Princeton BioMeditech

What Princeton BioMeditech does

Princeton BioMeditech Corporation (PBM) is a privately held medical device manufacturer founded in 1988 and headquartered in Monmouth Junction, New Jersey. The company develops, manufactures, and distributes rapid point-of-care diagnostic tests built on its patented lateral flow immunoassay technology, with an FDA-registered manufacturing facility operating under cGMP and ISO 13485:2016 certified quality systems. PBM markets over 70 different rapid tests across seven diagnostic categories: cardiac care (e.g., StatusFirst D-Dimer, LifeSign MI Troponin I), infectious disease (e.g., Status COVID-19/Flu A&B, BioSign Flu A&B, BioSign Strep A), fertility (e.g., BioSign hCG, OvuSign, SpermCheck Fertility), drugs of abuse (e.g., AccuSign, Status DOA 10 Panel, Status Fentanyl), tumor markers (e.g., Status BTA, Status IFOBT), veterinary diagnostics (e.g., Uricult Vet, Canine Heartworm), and food and environmental testing (e.g., BioSign E. coli, Listeria, Salmonella).

The company serves two primary customer segments: healthcare professionals (doctors' offices, laboratories, clinics) requiring rapid point-of-care testing, and consumers purchasing home-use products including pregnancy, fertility, and COVID-19 tests. Products are distributed globally in over 48 countries through local and national distributors, retailers, and partnerships with pharmaceutical and diagnostic companies. Pricing is structured on an Ex Works factory basis with one-time unit sales, supplemented by $9.9 million in U.S. Department of Defense and HHS funding received in 2021 and a National Institute of Biomedical Imaging and Bioengineering grant in 2024. PBM is currently extending its portfolio into instrument-based POC analyzers (Dxpress 2, listed as "coming soon").

Name

Princeton BioMeditech

Legal name

Princeton BioMeditech Corporation

Website

https://pbmc.com

Company type

Private

Founded year

1988

Operating status

Operating

Headcount range

51–100 employees

Ownership category

akta.pro rank

Product category

Point-of-Care In-Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Equipment and Supplies Manufacturing (3391)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

IVD Reagents, Assay Kits & Consumables (Non-instrument) (HLAHAAAM)

akta.pro secondary industries

Personal Medical Devices & Home Diagnostics (Thermometers, Blood Pressure Monitors, Glucose Meters, Rapid Tests) (CRADAMAK), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)

Keywords

• Rapid diagnostic tests
• Point-of-care diagnostics
• Lateral flow immunoassay
• In-vitro diagnostics
• Rapid test kits

Headquarters

HQ city

Monmouth Junction

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Operations, Personnel, Technology or R&D, Supply Chain, Marketing or Sales, Infrastructure

Revenue model

1. Rapid Diagnostic Products: One-time sale of rapid diagnostic test kits for professional point-of-care use and consumer in-home use. Products include cardiac markers, infectious disease tests, fertility tests, drugs of abuse tests, tumor markers, veterinary diagnostics, and food/environmental tests. Pricing is Ex Works from factory, with shipping and handling additional.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels3 records

Core offering

Princeton BioMeditech develops, manufactures, and sells an extensive menu of more than 70 rapid, one-step point-of-care diagnostic test kits using its proprietary lateral-flow immunoassay technology. Products span cardiac markers, infectious disease, fertility, drugs of abuse, tumor markers, veterinary diagnostics, and food/environmental pathogen detection, serving both professional healthcare settings and at-home consumer use. The company operates its own USA-based cGMP manufacturing facility and sells globally through distributors, retailers, and OEM partnerships.

Product overview

Princeton BioMeditech Corporation (PBM) is a world leader in rapid, point-of-care diagnostics, developing and manufacturing high-quality diagnostic products for both consumer in-home use and professional point-of-care settings. The company offers an extensive portfolio of over 70 different rapid tests across seven major categories: Cardiac Care (including StatusFirst D-Dimer, LifeSign MI CK-MB/Myo/Tn I, LifeSign MI Troponin I), Infectious Disease (including Status COVID-19/Flu A&B, BioSign Flu A&B, BioSign Strep A, BioSign H. pylori), Fertility (including BioSign hCG, OvuSign, SpermCheck Fertility, SpermCheck Vasectomy), Drugs of Abuse (including AccuSign, Status DOA 10 Panel, Status Nicotine, Status Fentanyl), Tumor Markers (including Status BTA, Status IFOBT), Veterinary Diagnostics (including Uricult Vet, Canine Heartworm Antigen Test, BioSign FMDV Ab), and Food and Environmental Diagnostics (including BioSign E.coli, BioSign Listeria, BioSign Salmonella). Products are sold under branded families including Status®, BioSign®, AccuSign®, LifeSign®, and OvuSign®.

Differentiator

Problem solved

Functional benefit

Brands

• LifeSign: Trademark of Princeton BioMeditech Corporation for diagnostic products including LifeSign MI, LifeSign Plus
• BioSign
• BioStrip
• AccuSign
• Status
• OvuSign
• SpermCheck
• StatusFirst

Products and services

• StatusFirst D-Dimer Rapid quantitative immunoassay for D-Dimer determination in human whole blood and plasma as an aid in diagnosing DVT, pulmonary embolism, and DIC; targeted at professional point-of-care use in hospitals, clinics, and laboratories.
• LifeSign MI CK-MB/Myoglobin/Troponin I (3-in-1 Cardiac Panel) Rapid qualitative immunoassay for simultaneous detection of CK-MB, myoglobin, and cardiac troponin I in whole blood, serum, and plasma as an aid in diagnosing myocardial infarction; for professional point-of-care use.
• LifeSign MI Troponin I Rapid qualitative immunoassay for cardiac troponin I in whole blood, serum, and plasma as an aid in diagnosing myocardial infarction; for professional point-of-care use.
• StatusFirst CHF NT-proBNP Quantitative NT-proBNP immunoassay intended to aid in the diagnosis of congestive heart failure in professional settings; product not currently available for sale.
• AccuSign COC (Cocaine Metabolite Test) One-step qualitative immunoassay for detecting cocaine (benzoylecgonine) and metabolites in urine for professional drugs-of-abuse screening; demonstrated 97–99% correlation with GC/MS.
• Status DOA 10 Panel Rapid 10-panel urine drug test simultaneously detecting methamphetamine, marijuana, opiates, cocaine, amphetamines, benzodiazepines, barbiturates, tricyclic antidepressants, phencyclidine, and methadone for professional forensic and clinical use.
• Status DS Nicotine Rapid immunoassay detecting cotinine, a nicotine metabolite, in urine at a 500 ng/mL cutoff to identify active nicotine intake; intended for professional use.
• Status Fentanyl Rapid qualitative urine immunoassay for fentanyl and its analogues; results in 10 minutes with 97–99% correlation to GC/MS reference method; intended for professional drugs-of-abuse testing.
• BioSign hCG-Urine Rapid immunoassay for qualitative detection of human chorionic gonadotropin in urine for early pregnancy detection; results in 3 minutes for professional clinical and consumer use.
• BioSign hCG-Urine/Serum Rapid immunoassay for qualitative detection of hCG in serum or urine for early pregnancy detection, intended for professional clinical use.
• BioStrip P Pregnancy Test Strip One-step pregnancy test strip for qualitative detection of hCG in urine; results in 3–5 minutes; intended for professional or consumer use.
• OvuSign Ovulation Prediction Test One-step home-use ovulation prediction test; results in 3 minutes with 99% accuracy in laboratory studies; targeted at consumers monitoring fertility.
• SpermCheck Fertility FDA-cleared at-home rapid test to detect sperm concentration in semen; results in 7 minutes; intended for consumer fertility screening.
• SpermCheck Vasectomy FDA-cleared at-home test for detection of sperm in semen following a vasectomy procedure; intended for consumer post-vasectomy confirmation.
• LifeSign Home Pregnancy Test One-step home pregnancy test with 99% accuracy in laboratory studies; designed for convenient consumer in-home use.
• BioSign E. coli O157 One-step rapid immunoassay for qualitative detection of E. coli O157 antigen in enriched cultures; intended as an early indicator of food or environmental pathogen contamination.
• BioSign Listeria Rapid one-step immunoassay for qualitative detection of Listeria monocytogenes in enriched food or environmental cultures.
• BioSign Salmonella Rapid one-step immunoassay for qualitative detection of Salmonella antigen in enriched cultures; used as an early indicator of food-borne contamination.
• Status COVID-19 Antigen Rapid Test for Home Use Rapid immunoassay for direct detection of SARS-CoV-2 antigen from anterior nasal specimens, FDA Emergency Use Authorized for at-home consumer use; results visually read in 15 minutes.
• Status COVID-19/Flu A&B Combined Test FDA 510(k)-cleared and CLIA-waived rapid immunoassay for simultaneous direct detection and differential diagnosis of SARS-CoV-2, influenza A, and influenza B antigens from anterior nasal and nasopharyngeal swab specimens; results in 15 minutes for professional point-of-care use.
• BioSign Flu A&B CLIA-waived in vitro rapid qualitative test for influenza type A and B antigens directly from nasal swab, nasopharyngeal swab, and nasal aspirate/wash specimens; used at the point of care by healthcare professionals.
• Status Strep A Flip Rapid test for Group A Streptococcal antigen directly from throat swab specimens using an innovative flip-cassette design; positive results in 5 minutes for professional point-of-care use.
• BioSign Strep A Rapid detection of Group A Streptococcal antigen directly from throat swab specimens in cassette format; results in 5–10 minutes for professional clinical use.
• BioSign H. pylori IgM/IgG/IgA Qualitative immunoassay for detection of anti-Helicobacter pylori antibody (IgM, IgG, IgA) in whole blood, serum, or plasma specimens using small sample volumes; for professional diagnostic use.
• BioSign Rubella IgG Immunochromatographic assay for qualitative detection of anti-Rubella IgG antibody in human serum or plasma; used to determine immune status or confirm recent infection in professional clinical settings.
• BioSign Mono IgM Rapid qualitative immunoassay for infectious mononucleosis heterophile antibodies in whole blood, serum, or plasma; results within 8 minutes with 99.9% sensitivity for professional point-of-care use.
• BioStrep Strep A Strip Strip-format rapid test for Group A Streptococcal antigen from throat swab specimens; results within minutes for professional clinical use.
• POC Analyzers (Dxpress 2 — Coming Soon) Point-of-care analyzer hardware for professional diagnostic testing; listed as a forthcoming product on the company website and not yet commercially available.
• Status BTA (Bladder Tumor Antigen) Test Rapid qualitative test for bladder tumor-associated antigen in human urine; indicated for use as an aid in monitoring bladder cancer patients in conjunction with cystoscopy for professional clinical use.
• Status IFOBT (Immunochemical Fecal Occult Blood Test) Kit Complete rapid immunochemical fecal occult blood test kit with no dietary restrictions; includes 30 test devices, 50 collection tubes, and 50 mailing envelopes for professional colorectal cancer screening programs.
• Uricult Vet Easy-to-perform in-office urine culture method for aiding diagnosis of urinary tract infections in dogs and cats; supports growth of 7 common uropathogens with 99% correlation to reference laboratory culture methods for veterinary clinics.
• Cultura M Incubator Compact durable incubator suitable for incubation of media dip paddles for veterinary diagnostics; companion equipment sold alongside Uricult Vet for veterinary clinics.
• Canine Heartworm Antigen Test Rapid USDA-cleared test for detection of adult Dirofilaria immitis antigen in canine serum, plasma, and whole blood; results in 10 minutes for veterinary clinical use.
• BioSign FMDV Ab (Foot-and-Mouth Disease Virus Antibody Test) Rapid immunoassay for qualitative detection of Foot-and-Mouth Disease Virus antibody in cattle whole blood, serum, or plasma; results in 15 minutes; intended for livestock veterinary screening.

Quantifiable outcome

• COVID-19/Flu A&B test: Anterior nasal sensitivity 93.8%, specificity 100%; Nasopharyngeal sensitivity 93.1%, specificity 100%
• +3 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• Major League Table Tennis (MLTT)minorGTM or Marketing Partner · 22 November 2025Princeton BioMeditech became a corporate partner of Major League Table Tennis for the 2025-26 season. Partnership includes branding and digital visibility for MLTT teams including Atlanta Blazers and Princeton Revolution. The league has expanded to ten teams and secured a national TV deal with CBS Sports.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• QuidelOrtho: QuidelOrtho is a leading rapid diagnostics manufacturer (Sofia, QuickVue, Triage) with overlapping lateral flow and POC immunoassay products across infectious disease, cardiac, and DOA — a direct competitor to PBM in the professional and CLIA-waived segments.
• Chembio Diagnostics: Chembio is a smaller-cap rapid diagnostics company focused on lateral flow immunoassays for infectious disease (HIV, COVID, dengue, syphilis), competing with PBM's BioSign infectious-disease line in global health and POC markets.
• OraSure Technologies: OraSure develops and sells rapid diagnostic tests including OraQuick (HIV, HCV), DOA, and infectious disease products — directly comparable to PBM in lateral flow technology, POC delivery, and consumer/professional channels.
• ACON Laboratories: ACON is a privately held manufacturer of rapid diagnostic tests spanning infectious disease, fertility, DOA, and cardiac markers with strong distributor-based global reach — closely mirroring PBM's business model and product portfolio.
• Trinity Biotech: Trinity Biotech manufactures rapid diagnostic tests including infectious disease, hemoglobin A1c, and DOA products, with a similar profile of lateral-flow-based POC immunoassays sold globally — a close peer in product type and market positioning.
• Meridian Bioscience (Revvity): Meridian Bioscience, now part of Revvity, supplies rapid diagnostic tests for infectious disease (Strep A, hCG, influenza, RSV) and DOA, directly competing with PBM's portfolio in hospital and physician-office POC channels.
• Sekisui Diagnostics (OSOM): Sekisui Diagnostics' OSOM brand markets lateral flow rapid tests for Strep A, hCG, mononucleosis, and influenza, directly overlapping PBM's BioSign and Status infectious-disease and fertility lines in professional POC channels.

Broad incumbents

• BD (Becton Dickinson): BD's Diagnostic Solutions segment includes the BD Veritor system for rapid immunoassays (Flu, Strep, COVID, RSV), competing directly with PBM's Status and BioSign lines while also offering a broader microbiology and lab automation portfolio.
• Abbott Diagnostics: Abbott operates broad rapid diagnostics franchises (Binax NOW, Panbio, i-STAT) across infectious disease and cardiac, including consumer and professional POC — competing with PBM across most categories but as part of a much larger diagnostics portfolio.
• bioMérieux: bioMérieux is a global in vitro diagnostics company with rapid immunoassay products (VIDAS) and food microbiology testing, partially overlapping PBM's infectious disease and food/environmental rapid test offerings within a much broader portfolio.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/princeton-biomeditech-corporation

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds2 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Princeton BioMeditech