Employment

Machaon Diagnostics compensation and benefits:

  • Competitive salary
  • 8 paid company holidays
  • Paid vacation and sick days
  • Comprehensive health and welfare benefits package
  • Employee share purchase plan
  • 401(k) retirement savings plan with matching employer contribution
  • Employee referral bonus
  • Relocation assistance, available for certain roles
  • Training and development opportunities
  • Workplace perks such as snacks and coffee, and flexible work schedules

Openings:

Job Title:

Clinical Research Project Manager

A Clinical Research Project Manager is in charge of coordinating study-related activities with Clinical lab, R&D, Business Development, Administration, and Quality Assurance teams. In this role project manager will use project-specific project planners and OKRs to manage study scope and timelines to ensure the overall growth and productivity of the Clinical research team.

The clinical Trials Project Manager is responsible for:
1. Management of incoming Request for Proposals (RFPs). Coordinate quote submission and contract execution.
2. Logging and tracking project scope and timelines.
3. Work with team leads to create project planners, short-term project milestones and manage deliverables.
4. Manage Audit schedules, deliverables
5. Schedule, Manage clinical research team calendars
6. Creation and Management of team OKRs

Minimum Position Requirements:
• Education: BA or BS with a minimum of 5 years of project management experience or MS with 3 years of project management experience or PG diploma in Clinical Trials Project Management with 2 years of Project Management experience.
• Desirable Experience: (a) A minimum of 2 years of project management experience in CRO or Pharmaceutical company, clinical research operations team.
• Knowledge: Must be knowledgeable regarding general laboratory practice and health and safety protocol.
• Special Skills/Equipment: Must be adaptable to the fast-paced work environment. Must have the mathematical ability, scientific background, and be able to recognize problems and troubleshoot appropriately. Must be able to collaborate with multiple teams. Must be able to communicate clearly and effectively in person and over the phone.

Please send cover letter and resume to Delanda@Machaondiagnostics.com

 

 

Job Title: Research Laboratory Scientist

Company:
Machaon Diagnostics Inc is an independent Clinical Reference Laboratory and CRO founded 18 years ago in Oakland, California. We specialize in coagulation and thrombosis, complement-mediated diseases, and rare disease genetics. Our mission at Machaon is to save more lives with lab testing. The laboratory is located on a hospital campus in the sunny San Francisco East Bay.

Job Responsibilities:

  • Develop, validate and implement genetic, cellular and biochemical assays (e.g., ELISA, clot assays, light transmittance assays, flow cytometry, RT-PCR).
  • Write validation reports, SOPs, reports for sponsor clients, IRBs, and FDA review.
  • Demonstrate high-level problem-solving skills and analytical abilities to successfully perform laboratory testing.
  • Maintain expertise in or knowledge of molecular and cellular biological techniques.
  • Adhere to established laboratory policies in areas of procedures, quality control, quality assurance, and safety and compliance.
  • Additional duties as assigned.

Experience Requirements:

  • Strong background in molecular and cellular biological techniques and demonstrated ability to perform bench work.
  • Must have excellent written and oral communication skills.
  • Strong analytical and organizational skills.
  • Must work effectively with an interdisciplinary team of scientists, physicians, lab technologists, quality assurance specialists, and client services team.
  • Must demonstrate a high degree of professionalism, integrity, enthusiasm and initiative on a daily basis. Must have ability to work in fast-paced environment and be solutions-oriented.
  • Attention to detail is critical: assay results will change clinical management of critically-ill patients!

Education Requirements:

  • PhD or MS in immunology, chemistry, biochemistry, molecular and cell biology or other biological science field.

To Apply:
Please send CV, cover letter and references to James Kain, PhD. (james.kain @ machaondiagnostics.com).

 

 

Job Title: Clinical Laboratory Scientist (CLS) Part-time, Full-time and Weekend shifts available, 9am-5pm

We are searching for clinical laboratory scientists (CLSs) to join Machaon Diagnostics’ Louisiana Coagulation for a unique opportunity. We are looking for a CLSs to fill a full-time or part-time position. You will be working in a state-of-the-art clinical laboratory that is internationally recognized for its expertise in coagulation, platelets, rare disease and genetic testing. The position involves the performance of various test types, which may include coagulation assays, platelet aggregation, ELISAs and others. We expect to train the hired candidate in all of these testing techniques.

Candidates with science degrees (chemistry, biochemistry, molecular and cell biology, medical technology, CLS, etc.) AND a current MLS or CLS board certification are welcome to apply.

Compensation is competitive and verified annually against current CLS rates offered in the region. Benefits include health, dental, vision insurance, 401K, profit sharing, paid time off, flex hours and other benefits, like an endless supply of gourmet coffee.

Machaon is a fun, fast-paced and challenging environment that delivers specialized clinical reference lab testing services to doctors and hospitals across the US. We also conduct contract research/ clinical trials for the pharmaceutical and biotech industries, making the workload fun and dynamic. Machaon Diagnostics was founded in 2003 by a team of CLSs and we invite you to learn from our creative and scientific approach to improving healthcare one disease at a time.

Our clients include the largest reference labs, major academic medical centers, pharmaceutical firms, biotech companies, and others.

This job is for the select few serious candidates that are positive, high-energy, uniquely detail-oriented and meticulous in QA/QC record keeping.

Your duties will include work in the following areas:
• Coagulation testing
• Platelet aggregation
• Stago Analyzers
• ELISA
• Test validation
• Lab assistant management

Please send your resume and references when applying for this position.

Machaon Diagnostics is an 18-year-old laboratory firm that is accredited by the College of American Pathologists (CAP), accredited by CLIA and licensed by multiple states. We are experts in hemostasis, thrombosis, immunology, special chemistry, platelet physiology/function, molecular diagnostics, and genetic assays.

The laboratory is located on Oak Street, in a fun neighborhood and just down the street from Ochsner Medical Center in New Orleans.

Please send CV, cover letter and references to Delanda@Machaondiagnostics.com.

 

Job Title: Quality Assurance Associate

Compensation: Competitive, Exempt

Employment Type: Full-Time, 9am-5pm (M-F)

Position Summary:

We are currently looking to hire a quality-driven individual with experience in the regulated environments of either the diagnostic laboratory, biotechnology industry, pharmaceutical industry, or clinical research trials environment(s). As a Quality Assurance Associate, you would be responsible for activities that support and continue to improve our foundational Quality Management program.

This unique opportunity would require familiarity with execution of day-to-day laboratory quality assurance tasks as well as provide the opportunity for oversight of longer-term quality assurance projects and initiatives within the team. Identification and implementation of continuous process-improvement activities is key to bringing our fast-growing operations to the next level. We are a dedicated team of individuals that nurture a culture of quality, value a growth-mindset, and enjoy taking on challenges with positivity and an appreciation for innovation and creativity while always striving for excellence.

The Quality Assurance Associate is responsible for performing and participating in activities and initiatives related to the support and maintenance our operational Quality Management program which is the framework for regulatory compliance within all of our working systems. The Quality Assurance Associate is expected to monitor and report on the existing quality systems utilized as well as identify and implement continuous quality process improvements to support our continued growth in the industry.

Main Responsibilities:

  1. Draft, approve, and review all manner of controlled documents such as standard operating procedures, policies, job-aids and forms
  2. Manage the review and development of key quality documentation such as: document control, non-conforming events & preventive and corrective action plans, audit and inspection reports, equipment qualification, training and competency programs, test method validations, preventive maintenance schedules, environmental-monitoring
  1. Establish and perform ongoing inspection-readiness activities
  1. Interpret, implement, and inspect for compliance with the internal quality management program and corresponding industry standards and regulations: FDA, CAP, CLIA, GLP, GCP, GCLP, GMP, HIPAA, GDPR, CLSI, ISO
  1. Manage the recording, tracking, and reporting of key quality metrics
  2. Participate in regular audits and inspections; both internal and external
  3. Maintain activities related to non-conforming event reporting and assist in performance of root-cause analysis and identifying corrective and preventive action plans
  4. Provide ongoing educational opportunities and/or training sessions for all staff in support of maintaining a culture of quality
  5. Identify and implement continuous process improvements
  6. Assist with other special projects, as assigned

Minimum Position Requirements:

Education: BS/MS in Clinical Laboratory Science, or PhD in Biology or related sciences

Desirable Experience: CLS (BS/MS) with 3-5 years of experience or PhD with 2+ years of experience in a quality or regulatory role in either a diagnostic laboratory, biotech/medical device field, clinical research and/or clinical trials environment(s).

Knowledge: Must be knowledgeable and familiar with clinical laboratory and/or clinical research industries and the corresponding regulatory standards and requirements. Must have direct experience with activities related to quality management program initiatives in a highly regulated environment.

Special Skills/Equipment: CLS/MLS certification is highly desired, but is not a requirement. Must possess a keen attention to technical and regulatory detail, an intrinsic desire and commitment to quality improvement, strong analytical ability, and a command of the English language; both verbal and written. A scientific background with experience recognizing systemic non-compliance and implementing long-term solutions is highly desired. This role is best suited for someone highly organized, articulate, systematic, and adept at managing multiple projects at once in a fast-paced environment with rigorous deadlines.

Physical Requirements: Office environment with the ability to remain in a stationary position, often standing or sitting for prolonged periods of time.

Working Relationships/Contacts: The incumbent will work directly with the Quality Assurance Manager, Clinical Research Associates, Clinical Research Scientists, Laboratory Assistants, Clinical Laboratory Scientists, PhD’s, MD’s and other department Supervisors, Managers, and Directors.

Uniform Requirements: Appropriate professional attire.

Days/Hours: Monday-Friday, 9:00AM-5:30PM. Work hours/variable shifts are negotiable.

To apply, please send a cover letter and a copy of your resume to: Delanda@Machaondiagnostics.com

Position Title: Quality Assurance Specialist; CRO

Reports To: Quality Assurance Manager

Position Summary:

The Quality Assurance Specialist; CRO is responsible for performing and managing all activities and initiatives related to the rare disease Clinical Research Operations (CRO) that ensure compliance with laboratory industry regulations and adherence to the quality management program. The Quality Assurance Specialist ; CRO is expected to monitor and manage the existing quality systems as well as identify and implement continuous process improvements for the department.

Main Responsibilities:

  1. Draft, approve, and review controlled documents such as standard operating procedures, policies, job-aids and forms
  2. Manage the development and review of key documentation such as: Study Plan Agreements, Clinical Research Protocols, IRB-related documentation, Clinical Study Reports, Training documentation, and data submission to research sponsors
  1. Perform and establish ongoing inspection-readiness activities
  1. Interpret, implement, and inspect for compliance with the internal quality management program and corresponding industry standards and regulations: FDA, CAP, CLIA, GLP, GCP, GCLP, GMP, HIPAA, GDPR
  1. Manage the recording, tracking, and reporting of key quality metrics
  2. Participate in regular audits and inspections; both internal and external
  3. Maintain activities related to non-conforming event reporting and assist in performance of root-cause analysis and identifying corrective and preventive action plans
  4. Provide ongoing educational opportunities and/or training sessions for all staff in support of maintaining a culture of quality
  5. Identify and implement continuous process improvements
  6. Assist with other special projects, as assigned

Minimum Position Requirements:

Education: BS/MS in Clinical Laboratory Science, or PhD in Biology or related sciences

Desirable Experience: CLS (BS/MS) with 3-5 years of experience or PhD with 2+ years of experience in a quality or regulatory role in either a diagnostic laboratory, biotech/medical device field, clinical research and/or clinical trials environment(s).

Knowledge: Must be knowledgeable and familiar with clinical laboratory and/or clinical research industries and the corresponding regulatory standards and requirements. Must have direct experience with activities related to quality management program initiatives in a highly regulated environment.

Special Skills/Equipment: CLS/MLS certification is highly desired, but is not a requirement. Must possess a keen attention to technical and regulatory detail, an intrinsic desire and commitment to quality improvement, strong analytical ability, and a command of the English language; both verbal and written. A scientific background with experience recognizing systemic non-compliance and implementing long-term solutions is highly desired. This role is best suited for someone highly organized, articulate, systematic, and adept at managing multiple projects at once in a fast-paced environment with rigorous deadlines.

Physical Requirements: Office environment with the ability to remain in a stationary position, often standing or sitting for prolonged periods of time.

Working Relationships/Contacts: The incumbent will work directly with the Quality Assurance Manager, Clinical Research Associates, Clinical Research Scientists, Laboratory Assistants, Clinical Laboratory Scientists, PhD’s, MD’s and other department Supervisors, Managers, and Directors.

Uniform Requirements: Appropriate professional attire.

Days/Hours: Monday-Friday, 9:00AM-5:30PM. Work hours/variable shifts are negotiable.

To apply, please send a cover letter and a copy of your resume to: Delanda@Machaondiagnostics.com

 

Title: Clinical Laboratory Assistant

Machaon Diagnostics is a clinical reference laboratory, specializing in the diagnosis, treatment and monitoring of hemostatic and thrombotic conditions. We are looking for a passionate, intellectually hungry, recent college graduate interested in gaining clinical laboratory, contract research, and clinical trial experience to fill our laboratory assistant job opening. Past laboratory assistants have had the opportunity to attend scientific conferences, followed by matriculation into CLS, MD, PharmD and other allied health graduate programs.

Job Details: Demonstrate proficiency and understanding of standard clinical laboratory practices. Review requisitions, orders tests and processes specimens in preparation for laboratory procedures. Perform general laboratory maintenance tasks including preparing reagents, re-stocking consumables and washing glassware. Assist with quality control and quality assurance paperwork. Assist with clinical trials including completion of Institutional Review Board documentation, subject recruitment, screening, and management, and performance of research related testing. Design and revise forms and protocols. Adhere to Machaon policies and procedures as directed by the supervisor, manager or medical director. Interact with patients, subjects, visitors, physicians, and coworkers in a professional and courteous manner.

Qualifications:
-B.A./B.S with coursework in chemistry, biochemistry, immunology, molecular biology,
statistics and related subjects required.
-6 months or more related experience preferred.
-Strong organizational skills
-Strong communication skills
-Proficiency in MS Excel, including statistical applications
-Must reside locally

Please send resume and cover letter via e-mail to: connie.ng@machaondiagnostics.com

Machaon Diagnostics is California’s only independent bleeding and clotting laboratory, located in Oakland on the Summit Campus of Alta Bates Summit Medical Center. Machaon Diagnostics is a CA-licensed, CLIA-accredited, CAP-accredited clinical
laboratory approved to provide high-complexity clinical lab testing services.

Position Title: Senior Clinical Associate with Phlebotomy

Reports To: Clinical Research Director

Position Summary:

The Senior Clinical Research Associate will participate in functions of both the clinical laboratory and clinical research at Machaon Diagnostics, and will report to the Director of Clinical Research and the Technical Supervisor.

Responsibilities:

Senior Clinical Research Associate is responsible for:

  1. Assisting in management of clinical trials and overseeing the smooth operation of clinical studies. Logging and tracking project scope and timelines.
  2. Preparing study materials such as study plans, IRB proposals, subject facing documents and deliverables. The role also includes engaging with research participants and sponsors, troubleshooting, informing study subjects details of the study, implementing informed consent, and liaising with sponsors or clinical research consultants to communicate needs to all involved in such studies.
  3. Assisting with data collection and management, presentation of findings and preparation of study reports.
  4. Assisting with regulatory compliance tasks and maintaining audit preparedness through revision and preparation of documents and forms. This includes assisting in preparing and editing validation materials for both clinical and research assays.
  5. Performance of low to moderate complexity assays under the supervision of licensed Clinical Laboratory Scientists (CLS) and Senior Research Scientists and statistical analysis of results may be required.
  6. Administrative support of CLS’ and technical supervisors, including but not limited to data management and organization, liaising with physicians and clinical laboratory clients, assisting with policy implementation, execution of good documentation policy practices, creating documents and forms, and quality assurance review of clinical laboratory material.
  7. Other special projects as needed.

Minimum Position Requirements:

• Education: BA or BS with minimum of 2 years of laboratory experience and clinical research  experience.

• Desirable Experience: (a) CA Certified Phlebotomy Technician (CPT-1) License, this role includes the collection of clinical and clinical research blood specimen via venipuncture, proper identification of individuals, labeling samples and processing samples for further clinical laboratory or research testing.

• Knowledge: Must be knowledgeable regarding general laboratory practice and health and safety protocol.

• Special Skills/Equipment: Must be adaptable to fast-paced work environment. Must have mathematical ability, scientific background and be able to recognize problems and troubleshoot appropriately. Must be able to collaborate with multiple teams. Must be able to communicate clearly and effectively in person and over the phone.

Physical Requirements: Mobility is required. Must be able to work in a laboratory environment with infectious, toxic and radioactive substances following OSHA regulations and laboratory protocols.

Working Relationships/Contacts:

The incumbent works directly with Director of Clinical Research, other Testing Personnel, the Technical Supervisor, Laboratory Manager, Laboratory Director, Medical Director, Clinical Research Associates, Laboratory Assistants and Clerical staff.

Uniform Requirements:

Appropriate professional attire, plus a clean lab coat and gloves and other personal protective equipment, as needed.

Days/Hours: Monday-Friday, 9:00AM-5:30PM. Overtime may be required.

To apply, please send a cover letter and a copy of your resume to: Delanda@Machaondiagnostics.com

Panels
Tests
Forms
Collection Guide
Education and Publications
Clinical Trial Services
Patients

Panels

Panel Name STAT Turnaround Time Draw Kit Available (Y/N) Sample Requirement
COVID-19-associated Thrombotic Microangiopathy (TMA) < 24 hours (7 days a week) No serum
Hemophagocytic Lymphohistiocytosis (HLH) Genetic Panel (UPDATED) 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
TMA-Complete Genetic Panel 48 hours Yes EDTA whole blood
Hypophosphatasia/Osteogenesis Imperfecta Genetic Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Polycystic Kidney Disease (PKD) Genetic Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
PlateletGenex Thrombocytopenia Panel 48 hours (M-F, two consecutive business days required) Yes EDTA Whole Blood
C3 Glomerulopathy Genetic Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Thrombophilia Genetic Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Factor XIII Genetic Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Dysfibrinogenemia Genetic Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Hemophilia-Complete Severe Bleeding Genetic Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
VWD-Complete Genetic Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
PlateletGenex Functional Defect Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Alport Syndrome Genetic Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
aHUS Genetic Panel 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Prolonged aPTT / PT Evaluation Panel < 24 hours No citrated plasma
Heparin Antibody Confirmation Panel < 24 hours (M-F) Yes serum
Mild Bleeding Disorder Panel < 24 hours No citrated whole blood
Hypercoagulability Panel < 24 hours No citrated plasma
Lupus Anticoagulant Screen < 24 hours No citrated plasma
Plavix Sensitivity Panel < 24 hours Yes citrated whole blood
von Willebrand Factor Profile with Multimer < 5 days No citrated plasma
Platelet Aggregation Study – Comprehensive < 24 hours No citrated whole blood
Dysfibrinogenemia Functional Panel < 24 hours No citrated plasma
Antiphospholipid Syndrome Criteria Panel < 24 hours Yes serum

Tests

Test Name STAT Turnaround Time Draw Kit Available (Y/N) Sample Requirement
CXCL9 24 hours No EDTA Plasma
CFH fusion and CFH region deletion/duplication analysis by MLPA 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
COVID-19 Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) (PF4 Antibody) < 24 hours (7 days a week) Yes serum
COVID-19 Antibody, Spike (IgG) – Qualitative < 24 hours (Mon. - Fri.) Yes serum
COVID-19 Antibody, Spike (IgG) – Titer < 24 hours (Mon. - Fri.) Yes serum
Soluble IL-2R alpha (CD25) < 24 hours (7 days a week) No serum
COVID-19 Diagnostic Genetic Test (mobile) 1-hour (on-site reaction time) Yes saliva swab in VTM, UTM, or DNA/RNA Shield
COVID-19 Diagnostic Genetic Test 24 hours (M-F) Yes respiratory swab in VTM, UTM, or DNA/RNA Shield
Familial Genetic Testing Please call. Yes EDTA Whole Blood
C3 Nephritic Factor (C3NEF) 1 Week No Serum
Inhibitor Titer (Hemlibra-specific) <24 hours Mon.-Fri. No citrated plasma
Hemlibra-specific Factor VIII (8) Activity <24 hours Mon.-Fri. No citrated plasma
Clinical Comments and Consultation from Medical Director < 24 hours No
Factor VIII (8) Activity – Chromogenic (Bovine reagent) <24 hours Mon.-Fri. (please call) No citrated plasma
Antiphosphatidylserine Antibody No serum
sC5b-9 Level 24 hours No EDTA plasma
Antithrombin III Gene Sequencing 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Factor II Gene Sequencing 48 hours (M-F, two consecutive business days required) Yes EDTA Whole Blood
Factor V Gene Sequencing 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Factor VIII Gene Sequencing and Factor VIII Inversions Assay 48 hours (M-F, two consecutive business days required) Yes EDTA Whole Blood
PAI-1 Gene Sequencing 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
MTHFR Gene Sequencing 48 hours (M-F, two consecutive business days required) No EDTA whole blood
ADAMTS13 Gene Sequencing 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Plasminogen Gene Sequencing 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Protein C Gene Sequencing 48 hours (M-F, two consecutive business days required) Yes EDTA whole blood
Protein S Gene Sequencing 48 hours (M-F, two consecutive business days required) Yes EDTA Whole Blood
Anti-CFH Antibody 48 hours Yes serum
PFA – Screen (Platelet Function Assessment) < 24 hours No citrated whole blood
ADAMTS13 Activity < 24 hours (7 days a week) Yes citrated plasma
Heparin Antibody Confirmation < 24 hours (M-F) Yes serum
Heparin (UFH) Level < 24 hours No citrated plasma
Platelet Aggregation Study – Comprehensive < 24 hours No citrated whole blood
Warfarin Sensitivity Genotype (CYP2C9 and VKORC1) < 1 week No EDTA whole blood
Thrombin Time < 24 hours No citrated plasma
Thrombin/Antithrombin Complex < 1 week No citrated plasma
von Willebrand Factor Antigen < 24 hours No citrated plasma
von Willebrand Factor Multimer < 5 days No citrated plasma
PT Mixing Study < 24 hours No citrated plasma
Reptilase Clotting Time < 1 week No citrated plasma
Ristocetin Cofactor Activity < 24 hours No citrated plasma
Ristocetin-induced Platelet Aggregation < 24 hours No citrated whole blood
Rivaroxaban (Xarelto) Level No citrated plasma
Russell Viper Venom Time (dilute) < 24 hours No citrated plasma
Thrombin Generation (normalized-ETP) < 24 hours No citrated plasma
Protein S Activity < 24 hours No citrated plasma
Protein S Antigen (Free) < 1 week No citrated plasma
Protein S Antigen (Total) < 1 week No citrated plasma
Prothrombin Fragment 1.2 (F1.2) < 1 week No citrated plasma
Prothrombin Gene Mutation < 24 hours No EDTA whole blood
Prothrombin Time < 24 hours No citrated plasma
Plavix Sensitivity – Genotype (CYP2C19 Genotyping) No EDTA whole blood
Aspirin Sensitivity – LTA (AA-induced Platelet Inhibition) < 24 hours No citrated whole blood
Ticagrelor Sensitivity – LTA (ADP-induced Platelet Inhibition) < 24 hours citrated whole blood
Brilinta Sensitivity – LTA (ADP-induced Platelet Inhibition) < 24 hours No citrated whole blood
Plavix Sensitivity – LTA (ADP-induced Platelet Inhibition) < 24 hours No citrated whole blood
Protein C Activity < 24 hours No citrated plasma
Protein C Antigen < 1 week No citrated plasma
Plasminogen Activator Inhibitor Activity < 10 days No citrated plasma
Plasminogen Activity < 5 days No citrated plasma
Plasminogen Antigen < 5 days No citrated plasma
Platelet Electron Microscopy Study This test is not offered STAT No ACD whole blood
Platelet Antibody ID – Indirect (GPIIb/IIIa, GP Ib/IX, GPIa/IIa) < 24 hours No serum
Inhibitor Titer (aPTT Factors) < 24 hours No citrated plasma
Inhibitor Titer (PT Factors) < 24 hours No citrated plasma
Lupus Anticoagulant Index < 24 hours No citrated plasma
MTHFR (A1298C) Gene Mutation < 1 week No EDTA whole blood
MTHFR (C677T) Gene Mutation < 24 hours No EDTA whole blood
Heparin Antibody ELISA (reflex) (PF4 Antibody) < 24 hours (7 days a week) Yes serum
Heparin (LMWH) Level < 24 hours No citrated plasma
Hexagonal Phospholipid aPTT < 1 week No citrated plasma
Homocysteine < 5 days No serum
Factor X (10) Activity < 24 hours No citrated plasma
Factor X (10) Activity – Chromogenic < 1 week No citrated plasma
Factor X (10) Antigen < 1 week No citrated plasma
Factor XI (11) Activity < 24 hours No citrated plasma
Factor XII (12) Activity < 24 hours No citrated plasma
Factor XIII (13) Activity – Quantitative < 1 week No citrated plasma
Fibrinogen Activity < 24 hours No citrated plasma
Fibrinogen Antigen < 1 week No citrated plasma
Fondaparinux (Arixtra) Level < 24 hours No citrated plasma
Dabigatran (Pradaxa) Level < 24 hours No citrated plasma
Euglobulin Clot Lysis Time < 1 week No citrated plasma
Factor II (2) Activity < 24 hours No citrated plasma
Factor V (5) Activity < 24 hours No citrated plasma
Factor V (5) Leiden Gene Mutation < 24 hours No EDTA whole blood
Factor VII (7) Activity < 24 hours No citrated plasma
Factor VIII (8) Activity < 24 hours No citrated plasma
Factor IX (9) Activity < 24 hours No citrated plasma
Antithrombin III Activity < 24 hours No citrated plasma
Antithrombin III Antigen < 1 week No citrated plasma
aPTT < 24 hours No citrated plasma
aPTT Mixing Study < 24 hours No citrated plasma
aPTT-FS (Factor Sensitive Reagent) < 24 hours No citrated plasma
aPTT-LA (Lupus Sensitive Reagent) < 24 hours No citrated plasma
aPTT-LA Mixing Study < 24 hours No citrated plasma
aPTT-FS Mixing Study < 24 hours No citrated plasma
Beta-2 Glycoprotein I Antibody (IgG, IgM, IgA) < 1 week No serum
ADAMTS13 Antibody < 3 days Yes citrated plasma
ADAMTS13 Inhibitor < 24 hours (7 days a week) Yes citrated plasma
Alpha-2 Antiplasmin Activity < 1 week No citrated plasma
Anticardiolipin Antibody (IgG, IgM, IgA) < 24 hours No serum
Activated Protein C – Resistance < 1 week No citrated plasma

Forms

Machaon Diagnostics has provided several downloadable documents to assist in ordering, processing and billing. Below please find links to our most frequently requested documents.

Collection Guide

Specimen processing is one of the most important aspects in the generation of accurate and reliable lab results. Many variables, such as, anticoagulant ratio, storage time and temperature, and surface of containers and drawing components can affect test results.

Machaon Diagnostics follows and recommends the use of the third edition of the National Committee for Clinical Laboratory Standards (NCCLS) guideline H21-A3: Collection, Transport, and Processing of Blood Specimens for Coagulation Testing and General Performance of Coagulation Assays.

Please contact the lab with any shipping questions

Specimen Collection

Frozen Citrated Plasma
Frozen citrated plasma is the specimen of choice for clotting assays and some ELISA testing. The anticoagulant used for these assays is 105 – 109 mmol/L, 3.13% – 3.2% of the dihydrate form of trisodium citrate (Na3C6H5O7 2H2O), buffered or nonbuffered.

Patients with hematocrit values above 55% should have their final citrate concentration corrected using the following equation:

X = (100 – PCV) / (595 – PCV) WB Volume

Where X is citrate volume required to prepare a whole blood volume (WB Volume) from a patient with a certain percent packed cell volume (PCV).

Please follow the listed suggestions for collection of citrated plasma samples.

  • A 1:9 ratio of anticoagulant to whole blood is imperative
  • Blood should be drawn directly into anticoagulant if possible
  • Syringe draws should be added to anticoagulant within 1 minute
  • Syringe draws should use no more that a 20mL volume syringe
  • A two-syringe technique is preferred for syringe draws
  • Coagulation draws should be the 2nd or 3rd tube drawn
  • Catheter draws should be avoided or under the advice of the attending physician
  • All tubes should be inverted at least 4 times to ensure adequate mixing
  • Suitable needle gauges range from 19 – 22 for coagulation and platelet testing
  • Cell-free plasma must contain less than 10,000 platelets/µL
  • Centrifugation should be performed at 1,500 × g for 15 or more minutes
  • Aliquots are frozen (<= -20ºC) promptly to minimize factor degradation
  • Specimens are shipped frozen on dry ice (-78.5ºC)

Frozen Serum
Frozen serum is the specimen of choice for most immunoglobulin detecting assays and many ELISA based tests. Whole blood is drawn into a glass or plastic tube possibly containing an activator. Please follow the tube manufacturer’s guidelines for tube handling and processing.

Please follow the listed suggestions for collection of serum samples.

  • Plastic tubes containing an activator should be inverted at least 4 times
  • Glass tubes without activator should be clotted for 2 hours at room temperature
  • Suitable needle gauges range from 19 – 22 for the serum based tests
  • Centrifugation should be performed at 1,500 × g for 15 or more minutes
  • Aliquots are frozen (<= -20ºC) before shipping and shipped on dry ice (-78.5ºC)

EDTA Whole Blood
EDTA anticoagulated whole blood is the specimen of choice for molecular genetic tests.

Please follow the listed suggestions for collection of genetic samples.

  • Blood should be drawn directly into anticoagulant if possible
  • Extracted DNA is acceptable if received from CLIA-certified labs
  • This must be a closed system draw to prevent contamination
  • All tubes should be inverted at least 4 times to ensure adequate mixing
  • Suitable needle gauges range from 19 – 22 to prevent cell lysis
  • A minimum of 2mL of whole blood is needed for genetic assays
  • No processing is required for this sample type
  • Ship this type of specimen at room temperature

Aliquoting Specimens
Submitting multiple aliquots (plasma or serum) for testing is an important aspect of clot, chromogenic and ELISA based tests. Aliquots of 1mL are requested for most of our assays. These should be frozen prior to shipment in a <= -20 C freezer or colder. Tubes should be placed into a rack to ensure the samples are frozen properly in the base of the tube. Freezing should occur within 1 hour of the time of draw. Please refer to the preferred number of aliquots when submitting samples.

Shipping

Shipment is a crucial aspect of clinical testing. Please follow the below instructions for easy shipments to the lab.

Local Shippers
Machaon Diagnostics contracts with Medical Couriers, Inc. (MCI). who service the entire San Francisco Bay Area and surrounding areas. MCI has a fleet of specially trained drivers that will visit your lab, clinic or office during specified times. Couriers carry dry ice, cold packs and room temperature containers for receipt of all specimen types.

Medical Couriers, Inc. can be phoned for individual pickup requests at the below number.

Medical Couriers, Inc.
(800)-652-1147

Place prepared samples and order forms in a shipping bag with Machaon and specimen type written in a clear and visible location.

Out-of-area Shippers
Please collect the following items:

  • Test Order Form
  • Packing material or newspaper
  • Styrofoam container, possibly with outer cardboard box
  • Packaging tape
  • Airbill for overnight shipments
  • ORM-A label for dry ice shipments (UN1845)
  • Dry ice (-78.5ºC) sufficient for transit time (5lb. per day)
  • Specimens in biohazard specimen transport bag

Packaging
Place the biohazard bag containing samples and the test order form into a Styrofoam container followed by dry ice. Fill remaining container space with packaging material and seal with packaging tape. Adhere a completed airbill and dry ice labels to the exterior of container in a visible location. Telephone your preferred overnight courier to request a pickup or place container in designated pickup area.

Please contact the lab with any shipping questions

Education and Publications

37th Annual Meeting of the Histiocyte Society Meeting

 

Podcasts

Education

Antiphospholipid Syndrome: criteria, non-criteria and triple positive testing – a video with Dr. Brad Lewis and Dr. Sciascia.

 

Platelet Functional Defects, from the clinic to genetics (a webinar given by Dr. Brad Lewis, Feb. 24, 2017)

Diagnosing Thrombotic Microangiopathies: TTP and atypical HUS: (A Grand Rounds presentation at Mattel Children’s Hospital, UCLA, to Pediatric Nephrology with Dr. Brad Lewis.)

A guide to the video content:

00:24 – Introduction (Why we should care about diagnosis of aHUS and TTP)
1:00 – What is microangiopathic hemolytic anemia (MAHA)?
1:16 – Blood smear with schistocytes
1:40 – Von Willebrand’s protein synthesis
02:09 – ADAMTS-13 and TTP pathophysiology
02:43 – How to interpret ADAMTS-13 activity testing and advantage of doing ADAMTS-13 activity testing with Machaon Dx
03:48 – Use of ADAMTS-13 testing to diagnose “Occult” TTP
04:40 – Ruling in or out aHUS with ADAMTS-13 activity testing
05:20 – Plasma exchange for aHUS patients
05:57 – The complement cascade and aHUS pathophysiology
08:04 –aHUS patients respond to eculizumab therapy
08:45 – Unlike TTP, aHUS has triggers in 70% of cases
09:26 – aHUS is a multisystem microvascular disease (aHUS-induced organs damage)
10:09 – aHUS presentation
11:41 – Can we differentiate TTP and aHUS clinically?
12:15 – 5 reasons why you should care about aHUS patients genotyping
14:17 – Advantage of doing aHUS genetic testing with Machaon Dx
14:52 – The punchline: aHUS and TTP diagnosis algorithm

Publications

Shapiro, AD. et al. Plasminogen replacement therapy for the treatment of children and adults with congenital plasminogen deficiency. Blood. 2018;131(12):1301–1310.

Stromsness B. et al. Physician Interpretation of Equivocal Results for aHUS Genetic Testing Varies Greatly and is Frequently at Odds with Laboratory Views. J Clin Apheresis. 2019; (abstract P-82).

Ero, MP, Kain, JS, inventors; Machaon Diagnostics, Inc., assignee. 2018 Dec 18. Method of diagnosis of complement-mediated thrombotic microangiopathies. United States patent US 10,155,983.

Tao J. et al. A rare case of Alport syndrome, atypical hemolytic uremic syndrome and Pauci-immune crescentic glomerulonephritis. BMC Nephrology. 2018;19:355.

Kain J. et al. Additional Genes Associated with Atypical Hemolytic Uremic Syndrome. ASN 2018 Abstract TH-PO713. 2018; (abstract).

Switala L. et al. Complement factor abnormalities detected in patients with suspected Heparin-induced Thrombocytopenia (HIT) but not in Thrombotic Thrombocytopenia Purpura (TTP). ISLH 2017 Abstract Proceedings. 2017; (abstract).

Ipe T. et al. An extremely rare splice site mutation in the gene encoding complement factor I in a patient with atypical hemolytic uremic syndrome. J Clin Apheresis. 2017;32(6):584-588.

Alge J. et al. Hemolytic uremic syndrome as the presenting manifestation of WT1 mutation and Denys-Drash syndrome: a case report. BMC Nephrology. 2017;18(1): 243.

Zhang K. et al. Atypical hemolytic uremic syndrome: a brief review. Hematology Reports. 2017;9(2):7053.

Jensen G. et al. Consumption of nattokinase is associated with reduced blood pressure and von Willebrand factor, a cardiovascular risk marker: resultd from a randomized double-blind, placebo-controlled, multicenter North American clinical trial. Integrated Blood Pressure Control. 2016;9:95-104.

Stromsness B. et al. Perceived clinical utility of ADAMTS-13 testing decreases quickly when turnaround time extends beyond two days. Int J Lab Hematol. 2015; (abstract).

Ero M. et al. Novel variant detection is essential when attempting to genetically confirm the clinical diagnosis of complement-mediated thrombotic microangiopathies (TMA). J Clin Apheresis. 2015; (abstract O-09).

Harbert J. et al. Inhibitory effects of fish oil on platelet-associated thrombin generation as measured by the calibrated automated thrombogram: an in vitro study. Int Soc Thromb Hemost 2014; (abstract 604).

Ero M. et al. Impact of telavancin on prothrombin time and activated partial thromboplastin time as determined using point-of-care coagulometers. J Thromb Thrombolysis. 2013;38(2):235-240.

Beattie DT. Et al. An in vitro investigation of the cardiovascular effects of the 5-HT4 receptor selective agonists, Velusetrag and TD-8954. J Thromb Thrombolysis. Vascular Pharmacology. 2013;58:150–156.

Ero M. et al. A pilot study on the serum pharmacokinetics of nattokinase in humans following a single oral daily dose. Alternative Therapies. 2013;19(3): 18-21.

Higgins D. et al. The inability of tegaserod to affect platelet aggregation and coronary artery tone at supratherapeutic concentrations. Archives of Pharmacology. 2012;385(1):103-9.

Ng C. et al. Oral bioavailability of nattokinase (NSK-SD). Am J Clin Pathol. 2010;134(suppl):11.

Lakshmi P. et al. Flavocoxid, an anti-inflammatory agent of botanical origin, does not affect coagulation or interact with anticoagulation therapies. Adv Ther. 2010;27(7):1-12.

Jeske WP. et al. Isolation and characterization of heparin from tuna skins. Clin Appl Thromb Hemost. 2007 Apr;12(2):137-45.

Fareed D. et al. Nitric oxide levels are upregulated in patients with malignancy-associated hypercoagulable state. Int J Lab Hematol. 2005; (abstract).

Jeske WP. et al. A survey of venous thrombosis models. Methods Mol Med. 2004;93:221-37.

Sahud et al. von Willebrand factor-cleaving protease inhibitor in a patient with human immunodeficiency syndrome-associated thrombotic thrombocytopenic purpura. Br J Haematol. 2002; 116(4):909-911.

Fenton JW. et al. Statin drugs and dietary isoprenoids downregulate protein prenylation in signal transduction and are antithrombotic and prothrombolytic agents. Biochemistry. 2002;67(1):85-91.

Ero M. et al. Comparative effects of a novel sulfated pentamannan oligosaccaride mixture (PI-88), heparin and related agents on the tissue factor-induced platelet activation and aggregation profile in whole blood. Thromb Haemost. 2001; (abstract 6260).

Ero M. et al. An antiplatelet drug, ticlopidine, inhibits heparin-induced thrombocytopenia responses as measured by platelet aggregometry and 14C serotonin release. Thromb Haemostasis. 1997; (abstract).

Clinical Trial Services

Machaon Diagnostics is a clinical reference laboratory, specializing in the diagnosis and monitoring of coagulation, platelet, rare disease and genetics. What makes us unique is our ability to provide high quality custom testing with unmatched speed.

  • Our Mission is to save more lives with lab tests.

Since 2003, we have grown into a team of clinicians, scientists, consultants and technologists bringing over 400 years of aggregated expertise to the field of laboratory medicine.

Our areas of clinical expertise include: Rare Disease Genetics, Advanced Hemostasis, (Platelets and Coagulation), Complement Disorders, Nephrology, Hematology / Oncology, Ophthalmology, Cardiology, Immunology, and Medical Devices.

Our esoteric and additional routine testing menu applies to a wide variety of disorders and clinical situations and, therefore, draws attention from both a national and an international clientele. Our clients include university medical centers, health system networks, community hospitals, commercial and research laboratories, doctor’s offices, biotechnology firms and pharmaceutical companies of all sizes.

CRO Services

Machaon Diagnostics provides a rapid and complete solution for companies in need of clinical trial services, contract research and independent marketing claim validation.  We have been performing studies on pharmaceuticals and medical devices since 2003. Design, subject recruitment, sample collection/storage, testing, statistical analysis, study reporting and manuscript preparation are all included in our comprehensive service. We have an extensive database of well-characterized study volunteers, allowing us to complete some IRB-approved clinical trials in as little as 5 weeks. Our subject database includes normal adult, rare disease, elevated risk of cardiovascular disease, high blood pressure, metabolic syndrome and other populations. We frequently collaborate with our larger CRO partners to aid in global clinical trials.

Research & Development

Machaon Diagnostics is the largest independent specialized coagulation lab in the US. We are a privately-owned company, staffed by MDs, PhDs, licensed clinical laboratory scientists (CLSs) and medical technologists.

As a clinical lab, we provide a unique testing environment for evaluating thrombotic and fibrinolytic potential. Pharmaceutical, device and biotech compounds and materials can be studied within established, validated and controlled clinical assays with verified reference ranges. Our clinical tests are further controlled within our quality assurance and proficiency testing policies and procedures. All tests can be modified or re-designed for best-fit analysis.

The Machaon Diagnostics laboratory facility is located on a medical center campus in Berkeley, California with a second lab site in New Orleans, Louisiana. Our scientists are published in and passionate about the field of laboratory medicine.

Assay Development

Our staff has had extensive experience designing unique testing systems or applying the proper testing system to answer the clinical trial questions quickly and accurately.

Custom-built assays, from ELISAs to NGS, from Sanger to Flow Cytometry, from TEG to Electrophoresis, we build custom assays to complement our pre-existing testing capabilities to fit your testing needs.

Machaon Diagnostics is a multi-state licensed, CLIA-accredited, College of American Pathologists (CAP)-accredited clinical laboratory authorized to provide high complexity clinical laboratory services. All laboratory testing is controlled within our Quality Assurance Program and studies are offered in a Good Laboratory Practices (GLP, 21CFR Part 58)/ EN 13612 environment.

Please contact the laboratory to inquire about any of these services.

Why the name, Machaon?

Machaon (pronounced may-chay-on) is a character from Homer’s Iliad (800 B.C.) and a key figure in the Trojan War. Described as a warrior, surgeon and healer, Machaon was revered for saving the lives of Menelaus, King of Sparta, husband Helen, and that of Philoctetes, the famed Achaean leader. Under the direction of King Agamemnon, Machaon saved these and many other warriors during the fierce Greek and Trojan War.

Patients

What you need to know

If you are reading this page, it likely means your doctor has ordered a bleeding or clotting test for you and would like you to get this test run at Machaon Diagnostics. Machaon Diagnostics is a clinical reference lab specializing in bleeding and clotting testing, one of the few independent coagulation labs in the country. We run very specific, unique blood tests which are often critical in helping doctors determine the correct course of treatment.

Machaon Diagnostics provides specialized lab testing to hospitals and doctors all over the country and is recognized for the speed and quality of our testing.

It is important to know that your insurance may or may not cover your testing. We have a long track record of working with patients to ensure they get the testing they need and we will work with you to help find a solution should your insurance not cover the testing we would provide.

If you are coming in to Machaon for a test, here are some things you will need to have with you:

  • Your doctors lab order
  • Your insurance information
  • Your identification
  • A list of your current medications
  • If you are coming in for a Platelet Aggregation, please remember you must fast before this test.

Machaon Diagnostics was founded in 2003 and is a California-licensed, CLIA-accredited, College of American Pathologists (CAP)-accredited clinical laboratory authorized to provide high complexity clinical laboratory services. All laboratory testing is controlled within our Quality Assurance Program and studies are offered in a Good Laboratory Practices (GLP, 21CFR Part 58)/ EN 13612 environment.

Please contact the laboratory if you have questions.