SDX Labs

What SDX Labs does

SDX Labs is a CLIA-certified, high complexity molecular diagnostic laboratory based in Pittsburgh, Pennsylvania, operated by Signature Diagnostics Inc. The company's commercial core is the Prenactive noninvasive prenatal screening (NIPS) product family, which uses cell-free DNA (cfDNA) analysis from a single maternal blood draw powered by Illumina whole-genome next-generation sequencing to screen for trisomy 21, trisomy 18, trisomy 13, sex chromosome aneuploidies, and — in the Prenactive NIPS Plus variant — five microdeletion syndromes including 22q11.2 (DiGeorge), 15q11.2 (Prader-Willi/Angelman), 1p36, Wolf-Hirschhorn, and Cri-du-chat. The Prenactive NIPS product claims the lowest published test failure rate in the industry at 0.1%, supported by published literature cited on the company's NIPS page.

Beyond NIPS, SDX Labs offers pharmacogenomic (PGx) testing for pharmaceutical companies and contract research organizations (CROs) running clinical trials, with a 2-business-day turnaround time and a panel covering tier 1 and tier 2 alleles per the Association for Molecular Pathology PGx Working Group, including CYP2D6 copy number variation detection. Through a partnership with NxGen MDx, the company resells carrier screening and hereditary cancer screening services.

SDX Labs generates revenue through insurance billing (private insurance and Medicaid with benefit investigation and prior authorization support), self-pay (credit card, HSA, FSA) collected prior to testing, a sliding-scale financial assistance program for qualifying patients based on HHS Poverty Guidelines, and project-based contracts with pharmaceutical companies and CROs for PGx clinical trial services. Customers reach the laboratory through healthcare provider orders, an online self-pay portal, a 75+ pharmacy and community testing site network across Greater Pittsburgh and the Mid-Atlantic, and dedicated enterprise sales for clinical trial sponsors. Complimentary board-certified genetic counseling is provided across the patient journey.

Name

SDX Labs

Legal name

Signature Diagnostics Inc.

Website

https://sdx-labs.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

11–50 employees

Short description

SDX Labs is a CLIA-certified molecular diagnostic laboratory in Pittsburgh operating the Prenactive noninvasive prenatal screening (NIPS) brand and pharmacogenomic testing for clinical trials, serving obstetricians, pregnant women, and pharmaceutical/CRO clients through a regional pharmacy and community testing network.

Ownership category

akta.pro rank

Product category

Molecular Diagnostic Laboratory Services

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215), In-Vitro Diagnostic Substance Manufacturing (325413), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

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

akta.pro primary industry

Genetic & Prenatal Testing Laboratories (HLAFAMAH)

akta.pro secondary industries

Prenatal, Newborn & Reproductive Diagnostics (NIPT, IVF/PGT, newborn screening) (HLAAALAJ), Pharmacogenomics (PGx) Decision Support (HLAAANAB), Companion Diagnostics (CDx) Development & Commercialization (HLAAANAC), Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI)

Keywords

• Noninvasive prenatal screening
• Molecular diagnostic services
• Pharmacogenomic testing
• Cell-free DNA analysis
• Clinical laboratory services

Headquarters

HQ city

Pittsburgh

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B and B2C

Offering type

Services

Cost components

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

Revenue model

1. Laboratory Testing Services - Insurance Billing: SDxLabs bills private insurance providers and government-sponsored plans (Medicaid) for laboratory testing services. The company performs benefit investigations to determine coverage and assists with prior authorization. Patients may have out-of-pocket costs depending on their deductible and plan requirements.
2. Laboratory Testing Services - Self-Pay: Self-pay option for patients without insurance coverage, those with high out-of-pocket costs, or those whose insurance does not cover the test. Payment (credit card, HSA, or FSA) is collected prior to testing. Amounts do not go toward insurance deductible or out-of-pocket maximum.
3. Financial Assistance Program: Sliding-scale financial assistance for qualifying uninsured, underinsured, or financially hardship patients utilizing the self-pay billing option. Cost reductions are based on family/household size and annual gross income per HHS Poverty Guidelines.
4. PGx Clinical Trial Services: Dedicated pharmacogenomic testing services for pharmaceutical companies and CROs supporting all phases of clinical trials. Revenue generated through project-based contracts with quotes and contracts managed by a dedicated clinical trial team.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels8 records

Core offering

SDxLabs operates a CLIA-certified molecular diagnostic laboratory that performs noninvasive prenatal screening (Prenactive NIPS and Prenactive NIPS Plus) using cell-free DNA analysis from maternal blood and Illumina whole-genome next-generation sequencing. The lab also provides pharmacogenomic (PGx) testing for pharmaceutical companies and CROs conducting clinical trials on CYP450-dependent therapies, with a 2 business day turnaround time. Supporting services include complimentary board-certified genetic counseling and (via partnership with NxGen MDx) carrier screening and hereditary cancer screening.

Product overview

SDxLabs operates as a molecular diagnostic laboratory offering a portfolio of genetic testing products and services centered on its Prenactive NIPS brand. The core offerings consist of Prenactive Noninvasive Prenatal Screen (basic chromosomal screening) and Prenactive Noninvasive Prenatal Screen Plus (expanded screening including microdeletion syndromes). Supporting services include genetic counseling (offered at no charge) and pharmacogenomic testing for clinical trials. Through its partnership with NxGen MDx, the company also offers carrier screening and hereditary cancer screening services. The company operates as a CLIA-certified high complexity molecular diagnostic laboratory.

Differentiator

Problem solved

Functional benefit

Brands

• Prenactive: Noninvasive Prenatal Screening (NIPS) product brand offering screening for chromosomal conditions including trisomy 21 (Down syndrome), trisomy 18, trisomy 13, sex chromosome aneuploidies, and microdeletion syndromes.
• Prenactive NIPS Plus

Products and services

• Prenactive Noninvasive Prenatal Screen (NIPS) Noninvasive prenatal screening using cell-free DNA from maternal blood and Illumina whole-genome next-generation sequencing to screen for trisomy 21 (Down syndrome), trisomy 18, trisomy 13, and sex chromosome aneuploidies. Performed via a single maternal blood draw as early as 10 weeks gestation with the lowest published test failure rate in the industry at 0.1%. Intended for expectant mothers and ordered by obstetricians and other prenatal care providers.
• Prenactive Noninvasive Prenatal Screen Plus (NIPS Plus) Expanded noninvasive prenatal screening that includes all conditions screened by Prenactive NIPS plus additional microdeletion syndromes including 22q11.2 deletion (DiGeorge/VCFS), 15q11.2 deletion (Prader-Willi/Angelman), 1p36 deletion, Wolf-Hirschhorn, and Cri-du-chat syndromes, as well as expanded autosomal trisomies. Performed via a single maternal blood draw as early as 10 weeks gestation.
• Pharmacogenomic (PGx) Testing for Clinical Trials Pharmacogenomic testing services for pharmaceutical companies and CROs supporting clinical trials, covering tier 1 and 2 alleles per the Association for Molecular Pathology PGx Working Group, including CYP2D6 copy number variation and specific gene panels (APOE, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A5, VKORC1). Offers an industry-leading 2 business day turnaround time with dedicated project management support.
• Genetic Counseling Board-certified genetic counselors provide pre-test and post-test counseling sessions to help patients understand genetic testing options, results, and healthcare implications. Sessions are offered free of charge to patients via phone (412-677-0664 Option 3) and email ([email protected]).
• Carrier Screening Carrier screening services offered through partnership with NxGen MDx, providing patients with early, actionable insights into genetic health.
• Hereditary Cancer Screening Hereditary cancer screening services offered through partnership with NxGen MDx, providing early insights into genetic health risks.

Quantifiable outcome

• 0.1% test failure rate — lowest published failure rate in the NIPS industry
• +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

Feature4 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• IlluminacoreTechnology or IntegrationSDxLabs partners with Illumina, a global biotechnology company specializing in genetic analysis solutions, to power its Prenactive NIPS screening. Illumina's whole-genome next-generation sequencing technology enables leading-edge detection rates with high specificity and clear, concise results for prenatal chromosomal abnormality screening.
• NxGen MDxcoreTechnology or IntegrationThrough partnership with NxGen MDx, SDxLabs offers additional screening services including carrier screening and hereditary cancer screening, providing patients with broader access to early, actionable genetic health insights beyond prenatal screening.
• SignatureDxcoreStrategic or Co-development PartnerSDxLabs is operated by SignatureDx, a local research company focused on developing early-stage diagnostic and phenotyping tools for complex diseases in collaboration with the University of Pittsburgh and Magee-Womens Research Institute. Signature Diagnostics established SDxLabs to provide relevant lab services and translate research into novel diagnostic solutions.
• University of PittsburghcoreStrategic or Co-development PartnerSDxLabs is developed in collaboration with the University of Pittsburgh, where co-founder Dr. David G. Peters drives innovation in genetics since 1995. Research collaboration focuses on developing novel diagnostic and screening solutions using cell-free DNA and other biomarkers obtained via non-invasive techniques.
• Magee-Womens Research Institute and FoundationcoreStrategic or Co-development PartnerCollaboration with Magee-Womens Research Institute and Foundation underpins SDxLabs' women's health focus. Dr. Dave Peters continues to drive innovation at the Institute. The work to discover diagnostic tools utilizes cell-free DNA and other biomarkers for women's reproductive health applications.
• 75+ Pharmacies and Community Testing SitesminorChannel Partner/ Reseller/ DistributorCommunity Testing Network comprising over 75 pharmacy and community testing site partners enabling SDxLabs services to reach communities across the Greater Pittsburgh area and throughout the Mid-Atlantic regions.
• UPMCminorGTM or Marketing PartnerUPMC is referenced as an insurance partner expanding NIPS coverage to all expectant mothers regardless of risk level, demonstrating growing payer coverage for prenatal screening services.

Scale indicators5 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Natera: Natera is the leading commercial player in cell-free DNA-based NIPS with its Panorama test and one of SDX's primary direct competitors in noninvasive prenatal screening. Both offer cfDNA-based NIPS to OBs and expectant mothers, competing on accuracy, failure rate, and turnaround time.
• Invitae: Invitae (now under Labcorp) offers broad genetic testing including reproductive health and PGx via Genelex. It is highly comparable to SDX's PGx clinical trial business, and Dan Doherty (SDX's Lead Clinical Trial PM) previously worked at Invitae.

Broad incumbents

• Labcorp (Integrated Genetics): Labcorp offers MaterniT21 (via Integrated Genetics) and a broad menu of reproductive and genetic diagnostics through a national laboratory network. It competes with SDX on NIPS as well as broader women's health panels, leveraging national reach and payer contracts.
• Myriad Genetics: Myriad operates in women's health (Prequel NIPS, Foresight carrier screening) and offers extensive pharmacogenomic and hereditary cancer testing. It is a broad incumbent competing with SDX across both core lines (NIPS) and adjacent women's health/PGx categories.
• Roche (incl. Ariosa/Sequenom): Roche acquired Ariosa and offers the Harmony prenatal test, one of the largest NIPS products in the US. It is a broad incumbent competing with SDX across reproductive health diagnostics at a global scale.
• NeoGenomics: NeoGenomics provides oncology-focused molecular and genetic testing with a pharma services arm supporting clinical trials. It overlaps with SDX's enterprise PGx clinical trial services and serves pharmaceutical sponsors with comparable project-based contracts.
• Quest Diagnostics: Quest Diagnostics is one of the two largest US clinical reference labs and offers Q-NIPT (NIPS via its partner) plus broad women's health and PGx menus. It is a broad incumbent that competes with SDX across NIPS, reproductive health, and pharmacogenomics.

Emerging players

• BillionToOne: BillionToOne offers UNITY (NIPS with single-gene NIPT) and is an emerging, venture-backed challenger in NIPS with novel molecular approaches. It represents a fast-moving emerging competitor with differentiated accuracy claims, overlapping most directly with Prenactive NIPS.
• Genomind: Genomind is a PGx-focused specialty lab serving psychiatry and other therapeutic areas. It is an emerging player in pharmacogenomic testing with overlapping CYP450-panel capabilities and similar specialty positioning relative to SDX's clinical trial PGx offering.
• Progenity (Pangea Biosciences): Progenity (now Pangea) historically offered NIPS (Preparent) and molecular diagnostics, competing in the same reproductive health category as SDX. It is an emerging/mid-stage NIPS player with overlapping customer segments (OBs and expectant mothers).

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/sdx_labs
• Facebookfacebook.com/sdxlabs?mibextid=LQQJ4d
• LinkedInlinkedin.com/company/sdx-labs

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

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 SDX Labs