W.H.P.M., Inc.

What W.H.P.M., Inc. does

W.H.P.M., Inc. is a privately held medical device manufacturer founded in 1993 and headquartered at 5358 Irwindale Avenue, Irwindale, California. The company designs, develops, and manufactures point-of-care immunoassay diagnostic tests built around lateral-flow chemistry applied to urine, oral fluid, and stool specimens. Its product portfolio spans five verticals: (1) drugs-of-abuse testing covering 40+ analytes including amphetamines, opioids, cocaine, marijuana, benzodiazepines, and synthetic drugs, with specimen validity testing (pH, specific gravity, creatinine, nitrite, oxidants, glutaraldehyde); (2) colorectal cancer screening via immunochemical fecal occult blood (iFOB) tests and the Hemosure Accu-Reader A100 automated fecal immunochemical test (FIT) analyzer; (3) fertility diagnostics; (4) harm-reduction test strips for fentanyl, xylazine, tianeptine, and alpha-PVP, plus supporting accessories such as micro scoops and clear graduated caps; and (5) a forthcoming H. Pylori fecal antigen test on the Accu-Reader A100 platform scheduled for launch at ADLM 2026.

The company operates a dual manufacturing footprint, with cGMP-compliant, ISO 13485-registered production in Beijing, China and through its wholly-owned US subsidiary CareHealth America Corp in Blue Earth, Minnesota (southwest of Minneapolis). Products are sold in two main ways: (a) direct sales to healthcare providers, clinical laboratories, workplace/drug-testing facilities (including DOT/SAMHSA-aligned programs), and harm-reduction organizations via phone, fax, email, and mail orders; and (b) an OEM/private-label channel in which the company files FDA Add-To-File documentation so that distribution partners can rebrand the diagnostics for professional, point-of-care, or over-the-counter consumer use, with exclusive distributorships available. Pricing is not publicly disclosed; orders are routed through a sales department that also provides free samples on request.

Distribution and demand generation are run through a sales-led motion with channel-partner overlay: trade-show presence at ADLM and MEDICA, downloadable catalogs and sales literature, a curated set of industry links (DOT, SAMHSA, AAMRO, FDA), and an active "Become a Distributor" recruitment program. There is no institutional investor, parent-company, or public-market ownership disclosed; the firm appears independently owned and keeps ownership structure opaque. Revenue, headcount, and ownership data are not disclosed in the public sources reviewed, representing a material data gap for any prospective investor or acquirer.

Name

W.H.P.M., Inc.

Legal name

W.H.P.M., Inc.

Website

https://whpm.com

Company type

Private

Founded year

1993

Operating status

Operating

Headcount range

11–50 employees

Short description

W.H.P.M., Inc. is a privately held US medical device manufacturer that designs, produces, and OEM/private-labels point-of-care immunoassay diagnostic tests — drugs-of-abuse panels, FIT/iFOB colorectal screening, fertility, and harm-reduction test strips — from cGMP facilities in the US and China.

Ownership category

akta.pro rank

Product category

In-Vitro Diagnostic Medical Devices

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

Personal Medical Devices & Home Diagnostics (Thermometers, Blood Pressure Monitors, Glucose Meters, Rapid Tests) (CRADAMAK)

akta.pro secondary industries

Quality Control, Calibrators, Standards & Proficiency Testing (IVD Consumables) (HLAHAAAL), Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ)

Keywords

• Point-of-care diagnostics
• Immunoassay test kits
• Drugs of abuse testing
• Harm reduction test strips
• Fecal immunochemical testing

Headquarters

HQ city

San Gabriel

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Medical Diagnostic Products: Sale of point-of-care medical diagnostic test products including drugs of abuse tests, fecal occult blood tests, fertility diagnostics, and harm reduction tests
2. Private Label/OEM Manufacturing: OEM services for immunoassay testing kits with client-specific private labeling options; FDA Add-To-Files submitted for distributor branding of medical diagnostic tests
3. Contract Manufacturing: Contract manufacturing services from design to product development, technology transfer, and assay development for medical diagnostic tests

Go-to-market motion2 records

Distribution channels4 records

Marketing channels4 records

Core offering

W.H.P.M., Inc. is a medical device manufacturer that designs, develops, and produces point-of-care immunoassay diagnostic test kits and automated analyzers. Its product portfolio covers drugs of abuse screening, fecal immunochemical testing (FIT) for colorectal cancer screening, fertility diagnostics, and harm reduction drug checking test strips. The company also offers private label/OEM and contract manufacturing services to distribution partners globally.

Product overview

W.H.P.M., Inc. is a medical diagnostic manufacturer offering a portfolio of point-of-care immunoassay testing products. The core offerings include Drugs of Abuse Tests (covering 40+ substances), Harm Reduction Tests (including fentanyl, xylazine, tianeptine, and alpha-PVP test strips), Automated FIT Testing with the Hemosure® Accu-Reader A100 analyzer, Fecal Occult Blood (iFOB) Tests, and Fertility Diagnostic Tests. The company also provides Private Label/Contract Manufacturing services for OEM partners and immunoassay development. Products are manufactured at facilities in Beijing, China and Blue Earth, MN (CareHealth America Corp), with private labeling options that include FDA submissions for professional, point-of-care, and over-the-counter consumer use.

Differentiator

Problem solved

Functional benefit

Brands

• Hemosure: Medical diagnostic brand including AccuReader A100 FIT Analyzer and clinical diagnostics solutions
• DrugCheck

Products and services

• Drugs of Abuse Tests One-step immunoassay test kits for detecting drugs of abuse in urine and oral fluid specimens, covering 40+ substances including amphetamines, opioids, cocaine, marijuana, benzodiazepines, and synthetic drugs. Sold to clinical laboratories, workplace drug testing programs, and occupational health providers.
• Hemosure Accu-Reader A100 FIT Analyzer Automated fecal immunochemical test (FIT) analyzer for quantitative measurement of human hemoglobin in stool samples, designed for clinical and point-of-care colorectal cancer screening workflows.
• Harm Reduction Test Strips Lateral flow drug checking test strips for harm reduction use, including fentanyl, xylazine, tianeptine, and alpha-PVP test strips, with high sensitivity and selectivity and accessory products (micro scoops, clear caps) for sample preparation. Sold to harm reduction organizations, syringe exchange programs, and drug checking services.
• Fecal Occult Blood (iFOB) Tests Immunochemical fecal occult blood tests for colorectal cancer screening, sold to clinical laboratories and healthcare providers.
• Fertility Diagnostic Tests Point-of-care diagnostic tests for fertility assessment and reproductive health monitoring, sold to clinical providers and consumers through point-of-care and OTC channels.
• Private Label and Contract Manufacturing Services OEM and contract manufacturing services covering design, product development, technology transfer, and assay development for immunoassay medical diagnostic tests, with FDA Add-To-File support for distributor branding. Exclusive distributorships available for distribution partners.
• DrugCheck Made in USA Product Line Drug testing products manufactured in the USA under the DrugCheck brand, leveraging the CareHealth America Corp (Blue Earth, MN) cGMP manufacturing facility for buyers requiring domestic sourcing.

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Scale indicators1 record

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• OraSure Technologies: Established point-of-care diagnostics company (InteliSwab, OraQuick HIV, Intercept oral fluid drugs-of-abuse) with broader product portfolio and stronger commercial footprint; a relevant comparable showing the scale W.H.P.M.'s harm reduction strategy could potentially reach.
• Psychemedics Corporation: Specialty drug testing services company using hair analysis, serving workplace, legal, and clinical testing channels; comparable end customers and use cases to W.H.P.M.'s DOA portfolio even though testing modality differs.
• QuidelOrtho Corporation: Large IVD manufacturer with a Sofia rapid test platform and broad diagnostics menu; serves as the dominant incumbent against which W.H.P.M. competes for shelf space at clinical labs and point-of-care channels.
• Abbott Diagnostics (Alere): Global IVD leader whose toxicology, i-STAT, and rapid diagnostics platforms compete with W.H.P.M.'s drugs-of-abuse and FIT offerings in hospital and reference lab channels; relevant scale benchmark and competitive headwind.

Direct peers

• MedMira Inc. Canadian rapid diagnostics company with regulatory-cleared infectious disease and drugs-of-abuse tests sold through distribution; comparable in scale, regulatory profile, and channel strategy to W.H.P.M.
• BTNX Inc. Canadian rapid diagnostic manufacturer best known for fentanyl test strips and a broad drugs-of-abuse and infectious disease portfolio; directly competes with W.H.P.M. in harm reduction strips and DOA immunoassays sold to similar harm reduction organizations and clinical distributors.
• EKF Diagnostics Holdings: UK-based point-of-care and clinical chemistry diagnostics manufacturer with hemoglobin/HbA1c and rapid test products; comparable in size, product mix, and OEM/private label orientation to W.H.P.M.
• Premier Biotech: Specialty rapid diagnostics company focused on oral fluid drugs-of-abuse testing and oral fluid specimen collection devices; directly comparable to W.H.P.M.'s oral fluid DOA tests and the broader harm reduction / workplace testing channels.
• American Bio Medica Corporation: US-based manufacturer of on-site drugs-of-abuse test kits (Rapid Drug Screen brand) serving workplace testing, criminal justice, and clinical markets; closely comparable in product category, customer base, and FDA-cleared rapid test positioning to W.H.P.M.
• Confirm BioSciences: Manufacturer of point-of-care drugs-of-abuse, fertility, and infectious disease rapid tests marketed through distributors; overlaps with W.H.P.M. on DOA and fertility product lines and the OEM/private label distribution model.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/WHPM1993
• Facebookfacebook.com/wh.pm.9

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Subsidiaries1 record

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 W.H.P.M., Inc.