Saladax Biomedical

What Saladax Biomedical does

Saladax Biomedical is a privately held, commercial-stage in-vitro diagnostics company founded in 2004 and headquartered in Bethlehem, Pennsylvania. The company develops and manufactures rapid therapeutic drug monitoring (TDM) immunoassays under its MyCare product line, targeting narrow-therapeutic-window drugs prescribed in psychiatry and oncology. Its core technology is a proprietary nanoparticle-based immunoassay platform that measures drug concentrations in blood, designed to run on existing clinical chemistry analyzers (including Beckman Coulter AU systems) without requiring new capital equipment, and via the portable MyCare Insite point-of-care device that delivers finger-prick results in approximately six minutes. The MyCare Psychiatry franchise covers six major antipsychotics (clozapine, risperidone, paliperidone, aripiprazole, olanzapine, quetiapine), while the MyCare Oncology franchise addresses 5-fluorouracil (My5-FU), paclitaxel, and busulfan dosing, including for gene therapy conditioning. The MyCare Clozapine Assay is the only commercial test of its kind authorized by the FDA.

The company's business model centers on sales of proprietary reagent kits to hospital and reference laboratories, supplemented by hardware sales of the MyCare Insite point-of-care device, licensing royalties from pharmaceutical partners (including companion diagnostic agreements with Janssen and Siemens Healthineers), and contract research services. Go-to-market relies on a hybrid of direct field sales in the United States led by National Sales Director Rob Bednarik, alongside a layered international distribution network featuring channel partnerships with Beckman Coulter (global), Thermo Fisher Scientific (international, from June 2026), HLS Therapeutics (exclusive Canada), and nine regional specialty distributors across Europe and the Middle East. Pricing is quote-based and not publicly disclosed. End customers include psychiatrists managing treatment-resistant schizophrenia and bipolar disorder, oncologists treating solid tumors with 5-FU and paclitaxel, hospital and reference laboratories, and pharmaceutical companies requiring companion diagnostics. The company holds a dense patent portfolio anchored by 17 patent families acquired from Janssen in 2022, plus founder Salvatore Salamone's personal estate of 41+ US patents and 100+ foreign patents.

Name

Saladax Biomedical

Legal name

Saladax Biomedical, Inc.

Website

https://saladax.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

11–50 employees

Short description

Saladax Biomedical is a privately held diagnostics company developing rapid nanoparticle-based therapeutic drug monitoring immunoassays for psychiatrists, oncologists, and hospital laboratories. Its MyCare product line measures blood levels of antipsychotics, 5-FU, busulfan, and other narrow-therapeutic-window drugs.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Toxicology & Therapeutic Drug Monitoring Laboratories (HLAFAMAF)

akta.pro secondary industries

Bioanalytical & PK/PD Sample Analysis (Trial Support) (HLAGAEAG), Bioanalytical Testing (PK/ADA/NAb) (HLAGADAA)

Keywords

• Therapeutic drug monitoring
• Clinical diagnostic assays
• Immunoassay diagnostics
• Psychiatry diagnostic tests
• Oncology diagnostic tests

Headquarters

HQ city

Bethlehem

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Reagent Kits Sales: Sale of MyCare™ diagnostic reagent kits for therapeutic drug monitoring in psychiatry and oncology. Products run on existing clinical chemistry analyzers or point-of-care devices.
2. Point-of-Care Device and Reagents: MyCare Insite point-of-care device with related diagnostic tests for measuring blood levels of antipsychotic drugs at point of care.
3. Licensing Royalties: Licensing agreements with pharmaceutical companies for companion diagnostics and clinical trial tests, including agreements with Janssen and Siemens Healthineers.

Pricing tiers

Go-to-market motion4 records

Distribution channels5 records

Marketing channels5 records

Core offering

Saladax Biomedical develops and manufactures therapeutic drug monitoring (TDM) immunoassays under the MyCare brand for psychiatrists and oncologists. Its portfolio includes laboratory-based assays for six major antipsychotics (clozapine, risperidone, paliperidone, aripiprazole, olanzapine, quetiapine), the MyCare Insite point-of-care clozapine device that returns results in about 6 minutes from a finger-prick blood sample, the My5-FU assay for 5-fluorouracil chemotherapy monitoring, and the busulfan TDM assay for gene therapy conditioning. The assays run on existing clinical chemistry analyzers already installed in hospitals and reference laboratories.

Product overview

Saladax Biomedical develops and manufactures therapeutic drug monitoring (TDM) assays for psychiatry and oncology. The core product portfolio consists of two main assay lines: the MyCare Psychiatry line (including MyCare Insite point-of-care device and laboratory-based assays for six antipsychotic drugs: clozapine, risperidone, paliperidone, aripiprazole, olanzapine, and quetiapine) and the MyCare Oncology line (including My5-FU for 5-fluorouracil monitoring and busulfan assays for gene therapy conditioning). The assays are designed to run on existing clinical chemistry analyzers (e.g., Beckman Coulter AU systems) without requiring new capital expenditure, or via the portable MyCare Insite point-of-care device for rapid bedside testing. Since 2007, Saladax's proprietary technology has been used in clinical laboratories and point-of-care settings worldwide, with distribution through partnerships including Beckman Coulter (global), Thermo Fisher (international expansion), and HLS Therapeutics (Canada).

Differentiator

Problem solved

Functional benefit

Brands

• MyCare™: Product line of therapeutic drug monitoring assays for psychiatry and oncology, including MyCare Psychiatry and MyCare Oncology tests such as MyCare Insite point-of-care device, My5-FU assay, and various antipsychotic drug tests.

Products and services

• MyCare Psychiatry Laboratory Assays

Quantifiable outcome

• Reduced inpatient hospital stays from 3 months to 3 weeks through rapid clozapine testing at South London and Maudsley NHS Trust
• +3 more outcomes

Named customers2 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

Feature5 records

Partnerships

Seven partnerships are on record, tiered core, regional, strategic and minor.

• Thermo Fisher ScientificcoreChannel Partner/ Reseller/ Distributor · 7 April 2026Global distribution partnership announced April 2026. Thermo Fisher will distribute Saladax MyCare Psychiatry and Oncology TDM assays through its established global commercial organization. Portfolio includes assays for monitoring top prescribed antipsychotics (clozapine) and chemotherapy agents. Distribution begins June 29, 2026 in select countries outside the US.
• Fosun Diagnostics (Fosun Pharmaceuticals)regionalChannel Partner/ Reseller/ Distributor · 14 May 2024China distribution partnership for personalized chemotherapy tests (5-FU). Tests approved for use in China.
• Janssen Pharmaceutica NVcoreTechnology or Integration · 5 April 2022Acquisition of antipsychotic drug testing patent portfolio from Janssen. Portfolio includes 17 patent families with 33 US patents and 296 international patents covering major antipsychotic drugs worldwide.
• Beckman CoultercoreChannel Partner/ Reseller/ Distributor · 15 March 2022Global distribution agreement for antipsychotic therapeutic drug monitoring assays. Saladax tests run on Beckman Coulter's scalable AU clinical chemistry analyzers (AU480, AU680, AU5800, DxC 700). Assays cover clozapine, risperidone/paliperidone, olanzapine, quetiapine, and aripiprazole. Distribution across Europe and US with global expansion plans.
• HLS TherapeuticscoreChannel Partner/ Reseller/ Distributor · 22 November 2021Exclusive distribution agreement for Canada. HLS distributes five MyCare Psychiatry Laboratory Assays measuring six commonly prescribed antipsychotics (clozapine, risperidone, paliperidone, aripiprazole, olanzapine, quetiapine). Also distributes MyCare Insite point-of-care device.
• AVROBIOstrategicStrategic or Co-development Partner · 4 May 2020Development and commercialization agreement for fully automated nanoparticle immunoassay kit for busulfan therapeutic drug monitoring. AVROBIO funds development to support their plato gene therapy platform. Assay designed to return busulfan metabolism results in minutes using standard hospital analytical devices.
• Siemens HealthineersminorOEM/ Whitelabel/ Licensing Partner · 18 January 2017Licensing agreement for Alzheimer's diagnostic tests. Saladax licensed diagnostic tests for early identification of Alzheimer's Disease to Siemens Healthineers.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Emerging players

• Myriad Genetics: Specialty diagnostics company with companion-diagnostic and pharmacogenomics franchises relevant to oncology dosing and personalized medicine. Comparable as a smaller, specialized diagnostics peer pursuing adjacent personalized-medicine use cases.

Broad incumbents

• Quest Diagnostics: Major US reference lab performing routine and specialty clinical and TDM testing. Peer via its psychiatric and oncology testing menu and as a potential channel competitor for Saladax's clinical lab assay portfolio.
• Siemens Healthineers: Large IVD and clinical chemistry incumbent with an Atellica/ADVIA Centaur analyzer installed base relevant to TDM. Already a Saladax licensing partner for Alzheimer's tests, and a broad comparable for any chemistry-analyzer-based TDM franchise.
• LabCorp: National reference laboratory running routine and specialty TDM panels including antipsychotic and chemotherapeutic drug levels. Comparable because it competes with hospital labs on TDM send-out volume and could also be a channel for Saladax assays.
• Bio-Rad Laboratories: Established clinical diagnostics and life science research company with a broad immunoassay and quality-control portfolio. Comparable as a mid-to-large specialty IVD peer that could expand into or compete with the TDM niche Saladax occupies.
• Roche Diagnostics: Global IVD leader offering a broad menu of clinical chemistry and immunoassays, including TDM-relevant platforms. Saladax founder previously led R&D here, and Roche represents both a potential acquirer and a broad incumbent whose analyzer strategy shapes Saladax's addressable installed base.
• Beckman Coulter: Major clinical chemistry and immunoassay analyzer vendor and Saladax's primary global distribution partner. Comparable because its AU/DxC analyzer platforms host Saladax assays, and its installed base defines the universe of labs Saladax can reach.
• Thermo Fisher Scientific: Recently announced global distribution partner for Saladax; broader life sciences and clinical diagnostics incumbent with overlapping immunoassay and clinical chemistry capabilities that creates both partnership leverage and a competitive ceiling.

Direct peers

• ARUP Laboratories: National reference laboratory known for specialized, esoteric testing including therapeutic drug monitoring and toxicology. Direct comparator for high-complexity TDM services that hospitals and clinics may send out instead of running on Saladax assays.
• ARK Diagnostics: Specialty in-vitro diagnostics company focused exclusively on therapeutic drug monitoring assays, including immunosuppressants and certain other drug classes. Direct peer to Saladax in the TDM immunoassay space with a similar reagent-kit business model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/Saladax
• Facebookfacebook.com/SaladaxBiomedical
• LinkedInlinkedin.com/company/saladax-biomedical

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds9 records

Investors8 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 Saladax Biomedical