Saladax Biomedical
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.
- Company typePrivate
- Founded2004
- HeadquartersBethlehem, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Saladax Biomedical firmographics
Firmographics- 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
Saladax Biomedical industry classification
Industry- 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
Where Saladax Biomedical is headquartered
LocationHeadquarters
- HQ city
- Bethlehem
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Saladax Biomedical business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Supply Chain
Revenue model
- 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.
- 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.
- Licensing Royalties: Licensing agreements with pharmaceutical companies for companion diagnostics and clinical trial tests, including agreements with Janssen and Siemens Healthineers.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | MyCare Psychiatry and Oncology Assays |
Go-to-market motion4 records
Distribution channels5 records
Marketing channels5 records
Saladax Biomedical product offering
Product offeringCore 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
Companies that use Saladax Biomedical
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles4 records
Saladax Biomedical technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Saladax Biomedical partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core, regional, strategic and minor.
- Thermo Fisher ScientificcoreGlobal 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)regionalChina distribution partnership for personalized chemotherapy tests (5-FU). Tests approved for use in China.
- Janssen Pharmaceutica NVcoreAcquisition 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 CoultercoreGlobal 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 TherapeuticscoreExclusive 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.
- AVROBIOstrategicDevelopment 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 HealthineersminorLicensing 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
Saladax Biomedical competitors and assessment
Company assessmentEmerging 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
Saladax Biomedical social profiles
Digital presenceSaladax Biomedical compliance and trust
Trust signalCompliance2 records
Saladax Biomedical financial estimates
Financial estimateRevenue estimate
Valuation estimate
Saladax Biomedical leadership team
Management profileNumber of profiles
Profiles10 records
Saladax Biomedical funding detail
Funding detailFunding overview
Funding rounds9 records
Investors8 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Saladax Biomedical M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Saladax Biomedical
What does Saladax Biomedical do?
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.
Is Saladax Biomedical a public or private company?
Saladax Biomedical is a private company. It is classified as venture growth investor backed and is currently operating.
When was Saladax Biomedical founded?
Saladax Biomedical was founded in 2004. It employs 11 to 50 people.
Where is Saladax Biomedical based?
Saladax Biomedical is headquartered in Bethlehem, United States, in the North America region.
How does Saladax Biomedical make money?
Three revenue lines are on record. Diagnostic Reagent Kits Sales are the primary driver. The others are point-of-Care Device and Reagents and licensing Royalties.
Who are Saladax Biomedical's main competitors?
Myriad Genetics is listed as an emerging player. Broad incumbents are Quest Diagnostics, Siemens Healthineers, LabCorp, Bio-Rad Laboratories, Roche Diagnostics, Beckman Coulter and Thermo Fisher Scientific. Direct peers are ARUP Laboratories and ARK Diagnostics.
Does Saladax Biomedical have an API?
No public API is recorded for Saladax Biomedical.
What industry is Saladax Biomedical in?
Saladax Biomedical's product category is In Vitro Diagnostics. Its primary akta.pro industry code is HLAFAMAF, Toxicology & Therapeutic Drug Monitoring Laboratories, with a secondary code of HLAGAEAG, Bioanalytical & PK/PD Sample Analysis (Trial Support). Its NAICS code is 325413 and its SIC code is 2835.