Acutis Diagnostics

What Acutis Diagnostics does

Acutis Diagnostics is a privately held, specialized clinical diagnostics laboratory founded in 2014 and headquartered in Hicksville, New York. It operates a 40,000-square-foot CLIA-certified and CAP-accredited core laboratory in Long Island and a 60,000-square-foot research facility in Monmouth Junction, New Jersey under its wholly owned subsidiary, Acutis Biosciences, with an additional technology center in Hyderabad, India. The company delivers molecular diagnostic testing services — primarily PCR-based infectious disease panels (respiratory, gastrointestinal, urinary tract, pharyngeal, STI, COVID-19) and LC-MS-based clinical toxicology — alongside pharmacogenetics and NGS-based oncology profiling, organized under the Acutis Reveal™ (clinical diagnostics) and Acutis Align™ (genomics/biomarker) sub-brands.

The core technology stack spans qPCR, ddPCR, and NGS, validated to CLIA and partially FDA-cleared standards, and is delivered through the I-Acutis provider portal with logistics coordinated via FedEx and UPS. The Acutis Biosciences CRO arm extends this platform into biopharma services including custom assay development, immunohistochemistry and digital pathology, CDx/IVD consulting, and partnerships with Illumina (TruSight Oncology 500, TruSight Hereditary Cancer Panel) and SOPHiA GENETICS (DDM Platform) for hereditary cancer screening and oncology clinical trial support. Cumulative operational scale is reported at over 5 million samples processed and 1+ million patients served across 13,000+ client accounts nationwide.

Acutis generates revenue primarily through per-test billing to physician practices, treatment centers, urgent care facilities, and behavioral health programs, reimbursed through insurance payers, with cash-pay options such as the $200 COVID-19 PCR list price for uninsured patients. The go-to-market is enterprise field sales organized by territory (with active territories in Kentucky, Illinois, and Colorado), complemented by payer-channel distribution following the March 2026 Humana-contracted entry into Kentucky, plus a Shopify e-commerce storefront for at-home point-of-care testing cups. The leadership team is founder-led, with CEO Jibreel Sarij, CSO Dr. Abdel Halim (a triple-board-certified molecular diagnostician, clinical chemist, and toxicologist), CTO/COO Azhar Bhatt, CCO David Goldberg, CFO Lisa McGrory, and Laboratory Director Marjorie Bon Homme.

Name

Acutis Diagnostics

Legal name

Acutis Diagnostics Inc.

Website

https://acutis.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

51–100 employees

Short description

Acutis Diagnostics is a privately held, CLIA-certified specialty clinical laboratory offering PCR-based infectious disease, toxicology, pharmacogenetics, and NGS oncology testing to physicians, treatment centers, urgent care, and payer networks across the United States.

Ownership category

akta.pro rank

Product category

Clinical Diagnostic Laboratory Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Other Scientific and Technical Consulting Services (541690)

SIC

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

akta.pro primary industry

Point-of-Care Testing (POCT) & Near-Patient Labs (HLAFAMAI)

akta.pro secondary industries

Molecular POCT / NAAT Systems (PCR/Isothermal platforms & cartridges) (HLAHAOAI), Infectious Disease POCT (Respiratory, STI, HIV, Sepsis) (HLAHAOAA), Point-of-Care (POC) & Rapid Diagnostics (near-patient, lateral flow) (HLAAALAG), Point-of-Care & Decentralized Trial Testing Services (HLAGAEAK)

Keywords

• Clinical diagnostic testing
• Molecular diagnostics services
• Infectious disease testing
• Clinical toxicology testing
• Pharmacogenetics testing

Headquarters

HQ city

Hicksville

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Laboratory Diagnostic Testing Services: Clinical laboratory testing services for infectious diseases, clinical toxicology, and pharmacogenetics. Revenue generated through billable laboratory tests to healthcare providers, insurance payers, and patients. Tests are ordered by physicians and billed through insurance or direct patient payment.

Pricing tiers

Go-to-market motion2 records

Distribution channels5 records

Marketing channels5 records

Core offering

Acutis Diagnostics is a specialized CLIA-certified, CAP-accredited clinical laboratory that performs PCR-based molecular diagnostic testing for infectious diseases (UTI, respiratory, gastrointestinal, pharyngeal, STI, COVID-19), clinical toxicology for medication monitoring and substance use disorder treatment, pharmacogenetics, and oncology genomic profiling. Services are delivered to healthcare providers through its own I-Acutis provider portal, with specimen logistics handled via FedEx and UPS, and results typically returned within 24 hours for most tests.

Product overview

Acutis Diagnostics operates as a specialized medical laboratory offering a comprehensive diagnostic testing portfolio organized under the Acutis Reveal™ brand for clinical diagnostics and Acutis Align™ brand for genomics/biomarker services. The core Acutis Reveal™ product line includes PCR-based infectious disease testing (respiratory, gastrointestinal, urinary tract, sexually transmitted infections, and pharyngeal pathogens), COVID-19 testing, and clinical toxicology/substance use testing. The company also provides pharmacogenetics panels, oncology genomic profiling through TruSight™ panels, immunohistochemistry, and custom assay development services through its CRO operations for biopharmaceutical clients. The portfolio spans point-of-care diagnostic products, laboratory-developed tests, and contract research services, unified by molecular diagnostics expertise and PCR technology platforms.

Differentiator

Problem solved

Functional benefit

Brands

• Acutis Reveal: Brand name for diagnostic test products including UTI, respiratory, gastrointestinal, and COVID-19 testing platforms
• Acutis Align
• TruSight Oncology 500 Tissue (TSO 500)
• TruSight Hereditary Cancer Panel

Products and services

• Acutis Reveal UTI PCR-based urinary tract infection testing with antibiotic sensitivity testing for rapid pathogen identification and treatment guidance, for healthcare providers.
• Acutis Reveal RIT (Respiratory Pathogen Testing) FDA-approved molecular respiratory testing capable of detecting up to 22 major respiratory pathogens, often returning results the same day samples are received.
• Acutis Reveal GIT (Gastrointestinal Pathogen Testing) One-step non-invasive gastrointestinal infection stool test screening for infectious bacteria, viruses, and parasites with results in 5 to 24 hours.
• Acutis Reveal PIT (Pharyngeal / Strep A Testing) FDA-cleared molecular test for rapid identification of Group A Streptococcus pyogenes causing Strep A disease.
• Acutis Reveal STI Testing Sexually transmitted infection testing including detection of Neisseria gonorrhoeae and other common STI pathogens.
• Acutis Reveal COVID-19 PCR Testing SARS-CoV-2 PCR testing with FDA approval and cash pricing of $200 for uninsured patients; most insurances cover testing at no cost.
• Acutis Reveal COVID-19 Antibody Testing SARS-CoV-2 antibody testing with cash price of $75 per unit.
• Acutis Reveal Flu A/B & RSV Assay Molecular assay for detection of Influenza A, Influenza B, and Respiratory Syncytial Virus.
• Acutis Reveal Bordetella Molecular testing for Bordetella pathogens.
• Medication Monitoring Testing Clinical toxicology testing services for medical specialists prescribing controlled medications, supporting medication-assisted treatment and substance use monitoring.
• Substance Use & Addiction Testing Comprehensive toxicology panels for detection of substances including fentanyl, 7-hydroxymitragynine (7-OH), and other drugs of abuse, for addiction treatment and behavioral health providers.
• TruSight Oncology 500 Tissue (TSO 500) Next-generation sequencing (NGS) pan-cancer comprehensive genomic profiling assay detecting variants across 523 DNA genes and 55 RNA fusion genes, measuring tumor mutational burden (TMB) and microsatellite instability (MSI), for biopharma clients via Acutis Biosciences.
• TruSight Hereditary Cancer Panel Illumina-powered NGS panel analyzing 113 genes associated with hereditary cancer predisposition, including 125 SNPs for identification and polygenic risk scoring, validated to CLIA standards.
• Acutis Align Oncology Panels Genomic testing panels for prospective genomic screening for patient enrollment in oncology clinical trials and retrospective analyses for clinical outcomes and drug target discovery, offered via Acutis Biosciences.
• Acutis Pharmacogenetics Panels Comprehensive drug-metabolizing gene panels for clinical research to discover pharmacogenes influencing drug metabolism or side effects, offered via Acutis Biosciences.
• Molecular Genomics Services Comprehensive molecular genomic assays including NGS, qPCR, ddPCR, and whole exome/transcriptome sequencing with bioinformatics solutions, for biopharma clients via Acutis Biosciences.
• Immunohistochemistry & Digital Pathology Services IHC assay development, validation, and clinical sample analysis including FISH, ISH, UroVysion FISH, HER2 FISH/CISH, and digital pathology with full slide scanning, via Acutis Biosciences.
• CDx & IVD Consulting Companion diagnostic and in-vitro diagnostic strategic consulting for drug and device development from discovery through registration and lifecycle management, via Acutis Biosciences.
• Custom Assay Development & Validation Expert assay development, qualification, and validation services for clinical trials, with rigorous testing to guarantee sensitivity, precision, specificity, and reproducibility, via Acutis Biosciences.
• I-Acutis Provider Portal Provider-facing web portal for test ordering and on-demand access to patient results, available to healthcare provider clients.

Quantifiable outcome

• 95% of UTI results delivered same day sample is received
• +4 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature7 records

Partnerships

Three partnerships are on record, tiered core.

• HumanacoreStrategic or Co-development Partner · 26 March 2026Acutis Diagnostics expanded services into Kentucky as a contracted provider with Humana. This payer partnership reflects Acutis' commitment to improving access to reliable diagnostic services while aligning with healthcare providers and payer organizations to support better patient outcomes through value-driven care.
• SOPHiA GENETICScoreTechnology or Integration · 1 August 2023Acutis Biosciences pairs with SOPHiA GENETICS for NGS sequencing assay development. The collaboration leverages the SOPHiA DDM Platform to support genomic screening in hereditary cancers, enhancing patient enrollment and stratification in oncology clinical trials. The partnership enables researchers to work more efficiently with comprehensive data insights for clinical decision-making.
• IlluminacoreTechnology or IntegrationAcutis Biosciences utilizes Illumina TruSight Oncology 500 Tissue (TSO 500) and TruSight Hereditary Cancer Panel for comprehensive genomic profiling. The partnership provides optimized panels with extensive coverage for DNA variants, RNA fusions, and splice variants in cancer testing.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Quest Diagnostics: Largest US clinical reference laboratory offering infectious disease, toxicology, and molecular testing. Overlaps with Acutis across routine and specialty clinical lab services and competes for the same physician-office specimen volume, but operates at vastly greater national scale.
• Laboratory Corporation of America (Labcorp): National clinical laboratory providing infectious disease, women's health, and esoteric diagnostics. Directly comparable business model to Acutis Diagnostics with similar payer and provider customer channels.
• Sonic Healthcare: Global diagnostics operator with US presence including clinical laboratories and clinical trial services. Comparable footprint to Acutis Diagnostics' clinical lab plus Acutis Biosciences CRO combination.
• Eurofins Scientific: Global network of clinical diagnostics and pharmaceutical testing laboratories. Comparable breadth across infectious disease, toxicology, and CRO/biopharma services touching Acutis' full operating footprint.

Direct peers

• BioReference Health (OPKO Health): Specialty clinical laboratory focused on molecular diagnostics, oncology, and women's health. Closely aligned with Acutis' Acutis Reveal infectious disease and Acutis Align oncology panel approach.
• NeoGenomics: Specialty oncology and clinical trial testing laboratory with NGS-based profiling. Comparable to Acutis Biosciences' CRO/biomarker discovery and TruSight oncology panel offerings.
• ARUP Laboratories: National reference laboratory affiliated with the University of Utah, providing esoteric infectious disease, toxicology, and molecular testing. Closely comparable to Acutis' specialty clinical lab positioning.
• PathGroup: Mid-sized US specialty pathology and molecular diagnostics laboratory serving physician offices and hospitals. Comparable specialty-lab, multi-state GTM and infectious disease/toxicology menu.

Emerging players

• Natera: Molecular diagnostics company specializing in cell-free DNA and genetic testing. Comparable as a molecular/PCR-based specialty diagnostics player, but with a more oncology/reproductive health focus versus Acutis' infectious disease/toxicology mix.
• Fulgent Genetics: Molecular genetics and NGS-based clinical laboratory providing oncology, infectious disease, and reproductive health testing. Comparable next-gen sequencing and specialty-diagnostics orientation to Acutis Biosciences.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/acutislab
• YouTubeyoutube.com/channel/UCyk5TJ0r8WsUc4ogs29nSKg
• Facebookfacebook.com/AcutisDiagnosticsInc
• LinkedInlinkedin.com/company/acutis-diagnostics
• Instagraminstagram.com/acutisdiagnostics

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

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 Acutis Diagnostics