Sekisui Diagnostics


Global medical diagnostics manufacturer and supplier of clinical chemistry reagents, point-of-care and molecular diagnostic tests, enzymes and pre-analytic systems. Offers contract development and manufacturing (CDMO) and biopharma services, technical support and training, and regulatory documentation to healthcare laboratories, manufacturers, distributors and point-of-care providers.

Industries

Health Care
Manufacturing
Medical Device

Nr. of Employees

large (251-1000)

Sekisui Diagnostics


Patents

Sample collection and transport devices, methods, and kits

US-9297724-B2

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Acetaminophen assay

US-8715952-B2

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Acetaminophen assay kit

US-8236519-B2

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Products

Total bilirubin clinical chemistry reagent (liquid, ready-to-use)

Liquid, ready-to-use reagent for quantitative measurement of total serum bilirubin; available in multi-component formats and compatible with multiple chemistry platforms.

Rapid multiplex lateral flow antigen test for SARS-CoV-2 and influenza A/B

Point-of-care lateral flow immunoassay that differentiates SARS-CoV-2, influenza A and influenza B from a single anterior nasal specimen with ~10-minute results; includes integrated QC features.

Molecular point-of-care multiplex COVID/Flu test

Compact molecular test for multiplex detection and differentiation of SARS-CoV-2 and influenza viruses designed for point-of-care settings.

Enzymes and specialty biochemicals for diagnostics

Specialty enzymes and biochemical reagents intended for use in diagnostic reagent manufacture and biosensor applications.

Pre-analytic systems and blood collection tube materials

Raw materials and systems for manufacturing plastic vacuum blood collection tubes and related pre-analytic components.

Metrix® Molecular Diagnostics System

A point-of-care molecular diagnostics system that utilizes isothermal technology to amplify DNA in a patient sample to detect pathogens, including an EUA approved COVID-19 test, with more infectious disease tests coming soon.

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Services

Technical transfer, process scale-up and contract production for diagnostic reagents, biosensors, biotherapeutics and related materials.

Onsite and remote product training, customer training center demonstrations and technical support from laboratory professionals.

Preparation and distribution of regulatory and safety documentation, package inserts, quick reference guides and date-extension documentation.

Expertise Areas

  • Point-of-care diagnostics
  • Clinical chemistry reagent manufacturing
  • Molecular diagnostics (POC)
  • Rapid lateral flow immunoassays
  • Show More (6)

Key Technologies

  • Lateral flow immunoassays
  • Molecular point-of-care testing
  • Multiplex respiratory diagnostics
  • Enzyme reagents and specialty biochemicals
  • Show More (5)

News & Updates

Global headquarters relocated to One Wall Street, Burlington, MA; describes new office space and customer training center.

Announcement of 510(k) clearance and launch of a CLIA-waived rapid test for detection and differentiation of SARS-CoV-2 and influenza A/B for professional healthcare settings.

Editorial/insight content on the role of diagnostic data in personalized medicine.

Company reference to over 1.8 billion tests performed annually using its reagents.

Received 510(k) clearance and launched a rapid multiplex respiratory virus test for professional settings (US).


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