Ariosa Diagnostics
Ariosa Diagnostics is a San Jose-based molecular diagnostics company that developed the Harmony Prenatal Test, a cell-free DNA-based non-invasive prenatal screen. Founded in 2009 and now a Roche subsidiary, it serves obstetricians and expecting parents globally.
- Company typePrivate
- Founded2009
- HeadquartersSan Jose, United States
- Headcount51–100
- GTM typeB2B
- OfferingServices
What Ariosa Diagnostics does
Ariosa Diagnostics is a molecular diagnostics company founded in 2009 and headquartered in San Jose, California, that developed the Harmony Prenatal Test, a cell-free DNA (cfDNA)-based non-invasive prenatal test (NIPT). The test analyzes fetal DNA fragments in maternal blood from a single blood draw as early as 10 weeks of pregnancy to screen for the most common chromosomal conditions, specifically Trisomy 21, 18, and 13, sex chromosome aneuploidies, and 22q11.2 microdeletion. Ariosa serves two principal segments: expecting parents seeking early, low-risk screening as an alternative to invasive diagnostic procedures such as amniocentesis or chorionic villus sampling, and obstetricians, gynecologists, and other healthcare providers who order the test through their clinical practices.
The underlying technology is built on Ariosa's proprietary DANSR methodology for cfDNA analysis, with a clinical evidence base of 80 peer-reviewed published studies as of January 2025 — among the most validated NIPT offerings globally. The test is operated as a laboratory-developed test (LDT) with CE-IVD marking, and the Harmony and DANSR trademarks are registered intellectual property. Headcount is reported at 51–100 employees, consistent with a focused clinical laboratory operation rather than a broad consumer-facing business.
Ariosa's go-to-market operates as a B2B clinical channel model: tests are ordered by clinicians and processed in laboratory settings for distribution to patients. Ariosa was acquired by Roche and now operates as a wholly-owned subsidiary of Roche Diagnostics, with the Harmony test marketed through Roche's global diagnostics commercial infrastructure. The company has historically raised approximately $67.5 million across three institutional rounds (2009, 2010, and 2012) from Domain Associates, Meritech Capital Partners, and Venrock, with John Stuelpnagel serving as Executive Chairman. Pricing is not publicly disclosed.
Ariosa Diagnostics firmographics
Firmographics- Name
- Ariosa Diagnostics
- Legal name
- Ariosa Diagnostics
- Website
- https://ariosadx.com
- Company type
- Private
- Founded year
- 2009
- Operating status
- Acquired
- Headcount range
- 51–100 employees
- Short description
- Ariosa Diagnostics is a San Jose-based molecular diagnostics company that developed the Harmony Prenatal Test, a cell-free DNA-based non-invasive prenatal screen. Founded in 2009 and now a Roche subsidiary, it serves obstetricians and expecting parents globally.
- Ownership category
- akta.pro rank
Ariosa Diagnostics industry classification
Industry- Product category
- Non-invasive Prenatal Testing (NIPT)
- NAICS
- Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Genetic, Cytogenetic & Prenatal Screening IVD (HLAHAAAI)
- akta.pro secondary industries
- Prenatal, Newborn & Reproductive Diagnostics (NIPT, IVF/PGT, newborn screening) (HLAAALAJ), Genetic & Prenatal Testing Laboratories (HLAFAMAH), Genetic & Genomic Testing (germline, somatic, carrier, pharmacogenomics) (HLAAALAD)
Keywords
Where Ariosa Diagnostics is headquartered
LocationHeadquarters
- HQ city
- San Jose
- HQ country
- United States
- HQ region
- North America
Markets served
Ariosa Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Distribution channels1 record
Marketing channels3 records
Ariosa Diagnostics product offering
Product offeringCore offering
Ariosa Diagnostics develops and offers the Harmony Prenatal Test, a cell-free DNA (cfDNA)-based non-invasive prenatal test (NIPT) that screens for chromosomal conditions including Trisomy 21, 18, and 13, sex chromosome aneuploidies, and 22q11.2 microdeletion. The test requires only a single maternal blood draw and can be performed as early as 10 weeks of pregnancy, providing a lower-risk screening alternative to invasive diagnostic procedures such as amniocentesis and chorionic villus sampling (CVS). The test is performed as a laboratory-developed test (LDT) and is CE-IVD marked.
Differentiator
Problem solved
Functional benefit
Products and services
- Harmony Prenatal Test Cell-free DNA-based non-invasive prenatal test (NIPT) that screens for common chromosomal conditions (Trisomy 21, 18, 13), sex chromosome aneuploidies, and 22q11.2 microdeletion. Performed using a single maternal blood draw as early as 10 weeks of pregnancy and offered to patients through their healthcare providers (obstetricians, gynecologists, and other prenatal care clinicians).
Quantifiable outcome
- 80 peer-reviewed published studies demonstrating accuracy as of January 2025
Companies that use Ariosa Diagnostics
Customer profileSegments2 records
Ideal customer profiles2 records
Ariosa Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature1 record
Ariosa Diagnostics partnerships and signals
Strategic signalScale indicators2 records
Recent moves6 records
Expansion highlights4 records
Ariosa Diagnostics competitors and assessment
Company assessmentBroad incumbents
- Quest Diagnostics: Large reference laboratory offering the QNatal Advanced NIPT among its women's health services, providing clinicians with an alternative prenatal screening channel to Harmony.
- Illumina: Major sequencing platform provider whose VeriSeq NIPT solution and broader genomics ecosystem compete with Roche/Ariosa in the cfDNA-based prenatal testing market, with deep installed-base and reagent advantages.
- PerkinElmer: Diagnostics and life sciences company with prenatal and newborn screening products (e.g., Vanadis NIPT platform) that compete with Roche/Ariosa in reproductive genetic screening workflows.
- Myriad Genetics: Genetic testing company with women's health and reproductive testing offerings (e.g., Foresight carrier screen) that intersect with Harmony's clinical and patient markets, particularly through OB/GYN channels.
- Hologic: Women's health-focused diagnostics company whose prenatal and molecular diagnostics portfolio overlaps with Harmony in OB/GYN and reproductive health testing channels.
- Laboratory Corporation of America (LabCorp): Acquired Sequenom and offers the MaterniT21 NIPT alongside a broad clinical laboratory menu, competing with Harmony for clinician-ordered prenatal screening volume in the U.S.
Others
- Bio-Techne: Life sciences tools and diagnostics company with reagents and exosome/DNA-based assay components used across the NIPT and reproductive diagnostics value chain, including suppliers and partners in the cfDNA testing ecosystem.
Regional players
- BGI Genomics: China-based genomics company offering NIPT services (NIFTY) globally, representing a major international competitor to Harmony, especially in Asia and emerging markets where Roche is also expanding.
Direct peers
- Natera: Direct NIPT competitor offering the Panorama prenatal test using cfDNA technology to screen for common chromosomal conditions, microdeletions, and twin pregnancies, targeting the same clinicians and patient population as Harmony.
Emerging players
- Invitae: Genetic information company offering reproductive and prenatal genetic testing (carrier screening and non-invasive options) that compete with Harmony in the women's health genetic testing space.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights5 records
Customer concentration
Ariosa Diagnostics social profiles
Digital presenceAriosa Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Ariosa Diagnostics leadership team
Management profileNumber of profiles
Profiles1 record
Ariosa Diagnostics funding detail
Funding detailFunding overview
Funding rounds3 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Ariosa Diagnostics 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 Ariosa Diagnostics
What does Ariosa Diagnostics do?
Ariosa Diagnostics develops and offers the Harmony Prenatal Test, a cell-free DNA (cfDNA)-based non-invasive prenatal test (NIPT) that screens for chromosomal conditions including Trisomy 21, 18, and 13, sex chromosome aneuploidies, and 22q11.2 microdeletion. The test requires only a single maternal blood draw and can be performed as early as 10 weeks of pregnancy, providing a lower-risk screening alternative to invasive diagnostic procedures such as amniocentesis and chorionic villus sampling (CVS). The test is performed as a laboratory-developed test (LDT) and is CE-IVD marked.
When was Ariosa Diagnostics founded?
Ariosa Diagnostics was founded in 2009. It employs 51 to 100 people.
Where is Ariosa Diagnostics based?
Ariosa Diagnostics is headquartered in San Jose, United States, in the North America region.
Who are Ariosa Diagnostics's main competitors?
Broad incumbents on record are Quest Diagnostics, Illumina, PerkinElmer, Myriad Genetics, Hologic and Laboratory Corporation of America (LabCorp). Bio-Techne is listed as an others. BGI Genomics is listed as a regional player. Natera is listed as a direct peer. Invitae is listed as an emerging player.
Does Ariosa Diagnostics have an API?
No public API is recorded for Ariosa Diagnostics.
What industry is Ariosa Diagnostics in?
Ariosa Diagnostics's product category is Non-invasive Prenatal Testing (NIPT). Its primary akta.pro industry code is HLAHAAAI, Genetic, Cytogenetic & Prenatal Screening IVD, with a secondary code of HLAAALAJ, Prenatal, Newborn & Reproductive Diagnostics (NIPT, IVF/PGT, newborn screening). Its NAICS code is 621511 and its SIC code is 2835.