What LifeSign does

LifeSign LLC is a privately held medical diagnostic company founded in 1998 and headquartered at 85 Orchard Road, Skillman, New Jersey. The company manufactures rapid point-of-care (POC) lateral-flow immunoassay diagnostic tests and serves three core customer segments: healthcare providers (hospitals, clinics, physician offices, laboratories) requiring rapid disease detection and screening, industrial and manufacturing operators needing microbial contamination monitoring (paint, cutting fluids, paper/pulp, fuel tanks), and food service and institutional buyers conducting surface hygiene verification. Product brands include Status™ (rapid immunoassays for infectious disease, cardiac markers, drugs of abuse, women's health, GI health, urology, and alcohol/nicotine testing), Cultura® (incubators), Easicult® (industrial dip slides), Hygicult® (surface hygiene paddles), and Uricult® (in-office urine culture). The portfolio spans 10 product categories sold through direct phone ordering (800-526-2125) and online catalog channels at unit-level pay-as-you-go pricing with no subscription component.

The underlying technology is proprietary rapid immunoassay lateral-flow chemistry delivering visual read-out results typically within 5–15 minutes, with several assays carrying CLIA-waived status for use without complex laboratory infrastructure. Notable technical features include the Status COVID-19/Flu A&B combination assay (FDA Emergency Use Authorization, 93.9%/91.4%/87.6% sensitivity for SARS-CoV-2, Flu A and Flu B), Status MI Troponin I and the 3-in-1 CK-MB/Myoglobin/Troponin I panel for acute myocardial infarction work-up, Status DS drugs-of-abuse assays with 97–99% GC/MS correlation, Status hCG with reduced hook-effect susceptibility, and the Uricult in-office urine culture system (Moderately Complex CLIA, 24-hour culture). Companion hardware includes the Cultura M incubator for dip-paddle workflows. Performance and packaging documentation (package inserts, safety data sheets, sell sheets) are downloadable from the company website.

The commercial model is a focused direct-to-provider B2B motion targeting institutional buyers, with no disclosed distributor or platform dependency, no subscription revenue, and no public listing or external institutional investment. Brand visibility was supplemented in late 2025 via a corporate sponsorship of Major League Table Tennis (announced November 22, 2025) alongside co-sponsors First Advantage and Princeton BioMeditech, coinciding with MLTT's expansion to ten teams and a CBS Sports television deal. The firm operates with 11–50 employees, no disclosed management team, no disclosed certifications or accreditations, and an operating geography skewed to the United States with an aspirational 'global' claim. The broader diagnostic biomarkers market is sized to reach $155.92 billion by 2030 at a 15.5% CAGR, against which LifeSign's current scope is a small, narrowly-scaled participant.

Name

LifeSign

Legal name

LifeSign LLC

Website

https://lifesignmed.com

Company type

Private

Founded year

1998

Operating status

Operating

Headcount range

11–50 employees

Short description

LifeSign LLC manufactures rapid point-of-care immunoassay diagnostic tests across 10 categories, including infectious disease, cardiac, women's health, urology, and drugs of abuse. Founded 1998 in Skillman, NJ, the privately held firm sells direct to healthcare, industrial, and food service customers.

Ownership category

akta.pro rank

Product category

Point-of-Care Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

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

akta.pro primary industry

Home-Use & OTC Rapid Self-Tests (Consumer POCT kits) (HLAHAOAK)

akta.pro secondary industries

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Home Diagnostic & Self-Test OTC Kits (HLAIADAO)

Keywords

• Rapid diagnostic tests
• Point-of-care testing
• Immunoassay diagnostics
• Medical diagnostic devices
• Infectious disease testing

Headquarters

HQ city

Skillman

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Point-of-Care Diagnostic Tests: LifeSign generates revenue through the sale of rapid point-of-care diagnostic test kits to healthcare providers. Products include tests for infectious diseases, cardiac markers, drugs of abuse, women's health, GI health, urology, and industrial hygiene applications.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

LifeSign manufactures and distributes rapid point-of-care immunoassay diagnostic test kits across multiple categories including infectious disease (COVID-19/Flu A&B, Strep A, RSV, H. pylori), women's health (hCG), cardiac care (Troponin I, CK-MB, Myoglobin), drugs of abuse, urology (BTA bladder tumor antigen), G.I. health (iFOBT), alcohol and nicotine, industrial microbial monitoring, and surface hygiene testing. Products are CLIA-waived or moderately complex, deliver visual results in 5-15 minutes, and are sold primarily to healthcare providers, clinics, laboratories, industrial customers, and food service operators.

Product overview

LifeSign is a medical diagnostic company delivering high quality rapid point-of-care testing solutions to the healthcare industry. The product portfolio includes Status™ branded rapid immunoassay tests across multiple categories including infectious disease (COVID-19/Flu A&B, Strep A, RSV, Mono, H. pylori), women's health (hCG pregnancy tests), cardiac care (Troponin I, CK-MB, Myoglobin markers), drugs of abuse (DOA), alcohol and nicotine, G.I. health (iFOBT, H. pylori), urology (BTA, Uricult), hygiene monitoring (Hygicult TPC, Y&F), and industrial applications (Easicult Combi, TTC). Supporting laboratory equipment includes the Cultura® M Incubator. The company also provides associated controls and reagents across product categories.

Differentiator

Problem solved

Functional benefit

Brands

• Status: Product line brand for rapid immunoassay diagnostic tests including Status COVID-19/Flu A&B, Status Flu, Status Mono, Status Strep A, Status DS (Drugs of Abuse), Status hCG, Status BTA, Status iFOBT, Status RSV, Status H. Pylori, Status Nicotine, and related products.
• Cultura
• Easicult
• Hygicult
• Uricult

Products and services

• Status™ COVID-19/Flu A&B Rapid immunoassay for the simultaneous direct detection and differential diagnosis of SARS-CoV-2, Influenza Type A and Type B antigen. FDA Emergency Use Authorization, visually read in 15 minutes with 93.9% COVID-19 sensitivity, 91.4% Flu A sensitivity, and 87.6% Flu B sensitivity. For clinical use by healthcare providers.
• Status™ Strep A Plus Rapid immunochromatographic assay for the detection of group A streptococcal antigen directly from throat swab specimens. Simple dip-and-read procedure with results in 5-10 minutes, 96.2% sensitivity and 98.7% specificity.
• Status™ Strep A Strip Rapid immunochromatographic assay for the detection of group A streptococcal antigen directly from throat swab specimens. CLIA WAIVED with results in 5-10 minutes, 96.2% sensitivity and 98.7% specificity.
• Status™ COVID-19 Antigen Rapid Test For Home Use Rapid immunoassay for the detection of SARS-CoV-2 antigen for use with anterior nasal swab for at-home use. Visually read results in 15 minutes.
• Status™ RSV Rapid immuno-chromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) from anterior nasal swab specimens. CLIA waived / 510K cleared with results in 15 minutes.
• Status™ hCG Rapid immunoassay for the detection of human chorionic gonadotropin (hCG) in serum or urine. CLIA WAIVED for urine testing with minimal susceptibility to the hook effect in pregnancy tests.
• Status™ hCG Strip Rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. CLIA WAIVED with simple dip-and-read procedure, 25 mIU/mL sensitivity, results in 3-5 minutes.
• Status™ H. Pylori Rapid immunoassay for the qualitative detection of anti-helicobacter pylori antibodies in human whole blood, serum or plasma. CLIA WAIVED for whole blood with fingerstick convenience and results in 10 minutes.
• Status™ iFOBT Immunochemical fecal occult blood test for qualitative detection of human hemoglobin in human fecal specimens. CLIA Waived with human hemoglobin specificity to reduce false positives.
• Status™ BTA Rapid test for the qualitative detection of bladder tumor associated antigen in human urine. CLIA WAIVED, indicated as aid in monitoring bladder cancer patients in conjunction with cystoscopy with results in 5 minutes.
• Uricult® Preferred in-office urine culture system. Moderately Complex CLIA category culture method for urinary pathogens with quick and convenient results within 24 hours.
• Status™ DS (Drugs of Abuse) One-step immunoassay for the qualitative detection of drugs of abuse and their metabolites in urine. Results in as little as 5 minutes with 97-99% correlation to GC/MS laboratory testing.
• Status™ DS Nicotine Rapid immunoassay for the detection of cotinine and nicotine metabolites in urine. Results in 5-10 minutes with 500 ng/mL cut-off to detect active nicotine intake.
• Easicult® Combi Dip slides for rapid microbial contamination monitoring in industrial environments such as paint manufacturing, cutting fluids, paper/pulp, and fuel tanks. Contains TTC media for bacteria and Rose-Bengal media for fungi.
• Easicult® TTC Dip slides containing TTC agar that allows almost all aerobic bacteria to grow for estimation of total bacterial counts. Helps prevent equipment breakdowns by detecting early signs of corrosion or contamination.
• Hygicult® TPC Rapid hygiene culture system for monitoring surface hygiene. Supports growth of bacteria, yeasts, and fungi with antidote to neutralize cleaning agents. AOAC approved with hinged dip paddle for testing surfaces, solids or liquids.
• Hygicult® Y&F Rapid detection of yeast and molds on surfaces using malt agar that supports yeast and mold growth while inhibiting bacteria. For on-site hygiene status testing in schools, hospitals, and food service industries.
• Cultura® M Incubator Small, durable, reliable incubator suitable for the incubation of dip paddles used in hygiene and industrial testing.
• LifeSign™ MI CK-MB, Myoglobin, Troponin I Rapid qualitative detection of CK-MB, Myoglobin, and Troponin I cardiac markers in human whole blood, serum and plasma to aid in diagnosis of acute myocardial infarction. Combined 3-in-1 test with results in 15 minutes.
• LifeSign™ MI Troponin I Rapid qualitative detection of Troponin I cardiac marker in human whole blood, serum and plasma to aid in diagnosis of acute myocardial infarction. Moderately Complex CLIA category with results in 15 minutes.
• Cardiac Marker Controls External quality controls for monitoring precision of LifeSign™ MI cardiac marker assessment assays. For use with Troponin I, CK-MB, and Myoglobin tests. Lyophilized material with 8-hour reconstituted stability.

Quantifiable outcome

• COVID-19 test: 93.9% sensitivity, 100% specificity
• +3 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 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 2025LifeSign partnered with Major League Table Tennis as a corporate sponsor for the 2025-26 season. This sponsorship includes branding and digital visibility for LifeSign as the league expands to ten teams and secured a national TV deal with CBS Sports.

Scale indicators2 records

Recent moves2 records

Expansion highlights4 records

Emerging players

• Response Biomedical: Response Biomedical develops rapid immunoassay POC tests focused on cardiovascular, infectious disease, and biodefense — overlapping with LifeSign's cardiac marker line (Troponin I, CK-MB, Myoglobin) and operating at a comparable specialty scale.
• Access Bio (CareStart): Access Bio manufactures the CareStart™ line of rapid diagnostic tests (COVID-19, Strep A, pregnancy, drugs of abuse) at competitive price points, making it a comparable emerging player in low-cost lateral-flow POC manufacturing.

Broad incumbents

• Siemens Healthineers (Rapid Diagnostics): Siemens Healthineers offers the CLINITEST® Rapid COVID-19 Antigen Test and a broader POC diagnostics portfolio, including cardiac markers, competing with LifeSign in clinical settings where integrated lab diagnostics buyers prefer large-vendor solutions.
• Becton Dickinson (BD): BD's Diagnostic Systems segment sells the BD Veritor™ system and a portfolio of CLIA-waived rapid tests (Strep A, Flu, RSV, COVID) — overlapping directly with LifeSign's Status™ branded infectious disease and women's health products.
• QuidelOrtho: QuidelOrtho is a major U.S. diagnostics company with a broad rapid immunoassay portfolio (e.g., Sofia, Triage, QuickVue) spanning infectious disease, cardiac, and women's health — directly competing with LifeSign across most product categories, though at much larger scale and with connected reader platforms.
• Abbott Diagnostics: Abbott's rapid diagnostics division (BinaxNOW, ID NOW, Clearview) competes head-to-head with LifeSign in infectious disease and offers CLIA-waived lateral-flow and molecular POC tests, plus a global distribution footprint that dwarfs LifeSign's.

Direct peers

• Sekisui Diagnostics (OSOM): Sekisui's OSOM® brand of rapid immunoassay tests (Strep A, hCG, Flu, Mono, Trichomonas) is one of the closest direct comparables to LifeSign's Status™ line, with similar product positioning, CLIA-waived portfolio, and physician-office distribution channel.
• Trinity Biotech: Trinity Biotech is a specialty diagnostics company offering rapid point-of-care tests (e.g., Uni-Gold HIV, Strep A) and clinical lab products, with comparable mid-sized manufacturing scale and an overlapping POC infectious-disease focus.
• Meridian Bioscience: Meridian manufactures rapid diagnostic tests for infectious disease (Strep A, C. difficile, RSV) and other immunoassay kits under its own and partner labels — a similarly sized specialty POC diagnostics company that competes in many of the same clinical categories as LifeSign.
• Princeton BioMeditech: Princeton BioMeditech develops and manufactures rapid immunochromatographic assays (hCG, Strep A, drugs of abuse) and is publicly listed as a co-sponsor alongside LifeSign for MLTT; it is a direct peer in lateral-flow assay manufacturing and a likely technology partner.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks5 records

Key highlights5 records

Customer concentration

• Xx.com/lifesignllc

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

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 LifeSign