Princeton BioMeditech Corporation


Developer and manufacturer of rapid point-of-care and in-home diagnostic tests, offering a portfolio of one-step immunoassay-based assays and related point-of-care products across infectious disease, cardiac markers, fertility, food/environmental testing and veterinary diagnostics. Operates a U.S. manufacturing site and maintains regulated quality systems and international regulatory approvals.

Industries

Biotechnology
Health Care
Industrial
Mechanical Engineering
Medical Device
Professional Services
Medical Equipment Manufacturing

Nr. of Employees

medium (51-250)

Princeton BioMeditech Corporation

Monmouth Junction, New Jersey, United States, North America


Patents

Method and devices for rapid diagnosis of foot-and-mouth disease

US-11598775-B2

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Monoclonal antibody against D-dimer and diagnosis agent for detecting D-dimer, crosslinked fibrin and its derivatives containing D-dimer by using the antibody

US-11506674-B2

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Monoclonal antibody against D-dimer and methods of use therefor

US-9897616-B2

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Products

Status COVID-19/Flu A&B Antigen Rapid Test (EUA)

Antigen rapid test intended for COVID-19 and influenza A/B detection; available under EUA for home use and in multi-test kits.

BioSign Flu A+B

Rapid immunoassay for qualitative detection of influenza A and B.

BioSign E. coli

One-step immunoassay for qualitative detection of E. coli O157 antigen in enriched food cultures; results in ~10 minutes.

Uricult Vet

In-office urine culture method supporting growth of common uropathogens for diagnosis of urinary tract infections in dogs and cats.

Canine Heartworm Antigen Test

Rapid assay for detection of Dirofilaria immitis antigen in canine serum, plasma or whole blood; cleared by USDA.

POC Analyzers (platform)

Planned/coming-soon point-of-care analyzer systems intended to be used with rapid test formats.

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Services

Contract manufacturing, OEM supply and product support for diagnostic partners.

Assay design, development and validation for rapid, one-step immunoassays across multiple indications.

Expertise Areas

  • Point-of-care diagnostics
  • Rapid immunoassay development
  • Cardiac biomarker testing
  • Infectious disease testing
  • Show More (5)

Key Technologies

  • One-step rapid immunoassays
  • Antigen detection assays
  • Antibody detection assays
  • Quantitative immunoassays for biomarkers
  • Show More (4)

News & Updates

Participation at ADLM 2024 Clinical Lab Expo in Chicago, IL; July 29 - August 1, 2024.

Participation at MEDICA 2024 in Dusseldorf, Germany; November 11 - 14, 2024.

ISO 13485:2016 certificate for quality management system.

Medical Device Single Audit Program (MDSAP) certificate.


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