ProciseDx
ProciseDx is a San Diego-based point-of-care diagnostics company using trFRET and proprietary Lumiphore technology to deliver 2–5 minute quantitative immunoassay results for gastroenterologists managing inflammatory bowel disease and biologic drug monitoring.
- Company typePrivate
- Founded2019
- HeadquartersSan Diego, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What ProciseDx does
ProciseDx is a point-of-care diagnostic platform company specializing in rapid quantitative immunoassays for gastroenterology applications. The company was created in June 2019 as a spinoff from Prometheus Laboratories and was originally wholly owned by Nestlé Health Science before Biosynex S.A. acquired a 37% stake via a Series A in July 2020 and ultimately acquired the full company in June 2023. Its core technology combines time-resolved Fluorescence Resonance Energy Transfer (trFRET) detection with proprietary Lumiphore chemistry, enabling lab-quality quantitative results from finger-prick whole blood in 2–5 minutes. The product portfolio centers on a compact benchtop instrument and an assay menu spanning C-Reactive Protein (CRP), infliximab (IFX), adalimumab (ADL), and fecal calprotectin (FCP), targeting therapeutic drug monitoring and inflammatory bowel disease management primarily for gastroenterologists and physician office laboratories.
The platform supports multiple specimen types including finger-prick whole blood, venous blood, serum, plasma, urine, saliva, and stool, with a proprietary stool collection device for FCP testing. ProciseDx commercializes through a hybrid model: direct sales to GI specialists and physician offices in the US post-FDA clearance, and a distribution-partner channel in EMEA led by Biosynex across 15+ countries. Revenue is generated through instrument placement (hardware sales) plus recurring assay/reagent kit sales in 20-test kit configurations. The instrument and CRP assay received FDA 510(k) clearance in November 2022; De Novo applications for IFX and ADL were submitted prior to the Biosynex acquisition.
The company operates from a 30,000 sq. ft. ISO 13485–certified facility in San Diego, California. As of mid-2021, more than 100 instruments had been shipped to EMEA, and approximately 30 were installed in the US by November 2022. ProciseDx raised approximately $23.5 million in total disclosed funding ($10.5M Series A in 2020 and a $13M convertible note in 2021) and was acquired by Biosynex S.A. in June 2023 to accelerate US commercialization of infliximab and adalimumab therapeutic drug monitoring tests.
ProciseDx firmographics
Firmographics- Name
- ProciseDx
- Legal name
- ProciseDx Corporation
- Website
- https://procisedx.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Acquired
- Headcount range
- 11–50 employees
- Short description
- ProciseDx is a San Diego-based point-of-care diagnostics company using trFRET and proprietary Lumiphore technology to deliver 2–5 minute quantitative immunoassay results for gastroenterologists managing inflammatory bowel disease and biologic drug monitoring.
- Ownership category
- akta.pro rank
ProciseDx industry classification
Industry- Product category
- Point-of-Care Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Rapid Antigen/Antibody Lateral Flow Tests (General Platform Category) (HLAHAOAH)
Keywords
Where ProciseDx is headquartered
LocationHeadquarters
- HQ city
- San Diego
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
ProciseDx business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- Instrument Sales: Sale of ProciseDx diagnostic instruments to physician offices, clinics, and distribution partners
- Assay/Reagent Kit Sales: Recurring sales of diagnostic assay kits including CRP, IFX, ADL, and FCP tests in 20-test kit configurations
- Distribution Partnership Revenue: Revenue from distribution relationships in EMEA markets through Biosynex and other distributors
Go-to-market motion2 records
Distribution channels3 records
Marketing channels4 records
ProciseDx product offering
Product offeringCore offering
ProciseDx develops and sells a point-of-care diagnostic platform consisting of a compact trFRET-based instrument and a menu of rapid immunoassay kits. The platform delivers lab-quality quantitative results in 2-5 minutes from a finger-prick blood sample and is targeted primarily at gastroenterology practices for therapeutic drug monitoring of infliximab and adalimumab and inflammatory marker testing (CRP, fecal calprotectin).
Product overview
ProciseDx offers a point-of-care diagnostic platform consisting of a compact instrument and a menu of rapid immunoassay tests. The platform uses trFRET (time-resolved fluorescence resonance energy transfer) detection combined with proprietary Lumiphore technology to deliver lab-quality quantitative results in 2-5 minutes. The core product portfolio includes the ProciseDx instrument platform and four main gastroenterology assays: Procise IFX (infliximab therapeutic drug monitoring), Procise ADL (adalimumab therapeutic drug monitoring), Procise CRP (inflammatory marker), and Procise FCP (fecal calprotectin). The system processes multiple sample types including finger prick whole blood, venous blood, serum, plasma, urine, saliva, and stool. The platform has received CE Mark for European commercialization and FDA clearance for the instrument and CRP assay in the United States.
Differentiator
Problem solved
Functional benefit
Products and services
- ProciseDx Instrument Platform A compact (approximately shoe-box sized, 8 inches / 20 cm wide) point-of-care diagnostic instrument that uses trFRET detection combined with proprietary Lumiphore technology to deliver lab-quality quantitative immunoassay results in 2-5 minutes. Compatible with finger-prick whole blood, venous blood, serum, plasma, urine, saliva, and stool samples. Sold to physician offices, gastroenterology practices, retail clinics, and urgent care facilities. CE Marked in Europe (Sept 2019) and FDA 510(k) cleared in the United States (Nov 2022).
- Procise IFX (Infliximab) Assay Therapeutic drug monitoring assay that quantitatively measures infliximab (Remicade and biosimilars Remsima, Inflectra, Flixabi, Renflexis) levels in blood, validated with a reportable range of 1.7-77.2 µg/mL. Delivers results in less than 5 minutes from a finger-prick blood sample on the ProciseDx instrument, enabling same-visit dose adjustments for IBD patients. Intended for gastroenterologists managing IBD patients on infliximab therapy.
- Procise ADL (Adalimumab) Assay Therapeutic drug monitoring assay that quantitatively measures adalimumab (Humira, Amjevita, Imraldi) levels in blood at the point of care in under 5 minutes from a finger-prick sample. Used by gastroenterologists to adjust biologic dosing for IBD patients during the same patient visit.
- Procise CRP (C-Reactive Protein) Assay Quantitative inflammatory marker assay that measures C-Reactive Protein (CRP) levels from finger-prick whole blood, venous blood, or serum in approximately 2 minutes, calibrated against the WHO standard with a reportable range of 3.6 mg/L - 100 mg/L. Performance: 7.0% CV at low QC and 5.4% CV at high QC. Used for monitoring IBD flares and acute inflammation. Sold in 20-test kit configurations.
- Procise FCP (Fecal Calprotectin) Assay Quantitative gastrointestinal assay for measuring fecal calprotectin levels to help differentiate IBS from IBD, predict IBD relapse, and monitor treatment response. Delivers results in 5 minutes from a stool sample collected with the dedicated Procise Stool Collection Device.
- Procise Stool Collection Device Specialized sample collection device used with the Procise FCP assay to enable reliable stool sample collection for fecal calprotectin testing at point-of-care.
Quantifiable outcome
- Results delivered in 2-5 minutes vs traditional lab testing taking days to weeks
- +3 more outcomes
Companies that use ProciseDx
Customer profileNamed customers3 records
Segments4 records
Ideal customer profiles2 records
ProciseDx technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
ProciseDx partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered minor and core.
- Biosynex COVID-19 BSS Antibody Test PartnershipminorProciseDx serves as US FDA agent and US distributor for Biosynex COVID-19 BSS Antibody test. Initiated clinical trials for finger prick blood claim. Test is a 10-minute blood test detecting anti-SARS CoV-2 antibodies.
- Dr. Magda MarquetcoreBoard Chair of ProciseDx. Co-founder of Althea Technologies, investor, scientist, entrepreneur and board member of multiple biotech companies. Serves on California governor's advisory committee for COVID crisis.
Scale indicators9 records
Recent moves10 records
Expansion highlights6 records
ProciseDx competitors and assessment
Company assessmentMarket position
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
ProciseDx social profiles
Digital presenceProciseDx compliance and trust
Trust signalCompliance3 records
ProciseDx financial estimates
Financial estimateRevenue estimate
Valuation estimate
ProciseDx leadership team
Management profileNumber of profiles
Profiles7 records
ProciseDx funding detail
Funding detailFunding overview
Funding rounds1 record
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ProciseDx 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 ProciseDx
What does ProciseDx do?
ProciseDx develops and sells a point-of-care diagnostic platform consisting of a compact trFRET-based instrument and a menu of rapid immunoassay kits. The platform delivers lab-quality quantitative results in 2-5 minutes from a finger-prick blood sample and is targeted primarily at gastroenterology practices for therapeutic drug monitoring of infliximab and adalimumab and inflammatory marker testing (CRP, fecal calprotectin).
Is ProciseDx a public or private company?
ProciseDx is a private company. It is classified as corporate owned and is currently acquired.
When was ProciseDx founded?
ProciseDx was founded in 2019. It employs 11 to 50 people.
Where is ProciseDx based?
ProciseDx is headquartered in San Diego, United States, in the North America region.
How does ProciseDx make money?
Three revenue lines are on record. Instrument Sales are the primary driver. The others are assay/Reagent Kit Sales and distribution Partnership Revenue.
Does ProciseDx have an API?
No public API is recorded for ProciseDx.
What industry is ProciseDx in?
ProciseDx's product category is Point-of-Care Diagnostics. Its primary akta.pro industry code is HLAHAOAH, Rapid Antigen/Antibody Lateral Flow Tests (General Platform Category). Its NAICS code is 325413 and its SIC code is 2835.