Myriad Genetics Launches FirstGene Multiple Prenatal Screen

Myriad Genetics, Inc., a significant leader in molecular diagnostic testing and precision medicine, announced the full commercial launch of FirstGene Multiple Prenatal Screen, the only lab test which runs four prenatal genetic screens concurrently from a single blood draw as early as eight weeks gestation. The FirstGene screen delivers fetal chromosome screening, fetal single-gene screening, patient carrier screening and fetal RhD screening in one incorporated report. The screen has better than 98% analytical sensitivity and greater than 99% analytical specificity.

With outcomes expected to be delivered in around 10 days, the FirstGene screen is intended to support physician know sooner by streamlining a historically fragmented prenatal screening technology. The screen brings together many guideline-supported screening modalities in one order, deprived of the requirement for a reproductive partner sample, supports providers deliver actionable insights for patients previous in pregnancy.

"The FirstGene screen shows the next generation of prenatal genetic screening, applying a new strategies to derive a broad range of health insights from a single blood sample," said Brian Donnelly, Chief Commercial Officer, Myriad Genetics. "Providing four key prenatal genetic results with a competitive turnaround time helps clinicians make informed decisions during a patient's pregnancy. One order. One draw. One report. Four simultaneous screens."

The FirstGene screen integrates four distinct prenatal genetic screens into a single assay:

Fetal chromosome screen assesses fetal challenges for common chromosomal conditions, involving trisomy: Down syndrome, trisomy: Edwards syndrome, and trisomy: Patau syndrome; sex chromosome aneuploidies; and 22q11.2 microdeletion: DiGeorge syndrome, with more than 99% analytical specificity and sensitivity.
Fetal single gene screen assesses fetal risks for common, actionable recessive conditions with more than 98% analytical sensitivity and greater than 99% analytical specificity, with no reproductive partner sample required.
Patient carrier screen evaluates the carrier status of the pregnant lady for 20 recessive conditions, involving spinal muscular atrophy, cystic fibrosis, sickle cell disease and fragile X syndrome, with greater than 99% analytical sensitivity and specificity.
Fetal RhD screen assesses RhD compatibility among the pregnant patient and fetus with greater than 99% analytical sensitivity and specificity for copy number variant calling.

The FirstGene screen was developed appling a rigorous, data-driven approach that involves extensive analytical testing, product optimization, and performance authentication. Throughout advancement, results were continuously evaluated for precision, reliability, and consistent product performance.

“As an OB/GYN, I know that in prenatal care, timing and access matter. Every additional test, blood draw or follow-up appointment can create friction for patients and providers alike and may delay access to important information that helps patients better understand their pregnancy,” said Dallas Reed, MD, Principal Medical Advisor, Myriad Genetics. “The FirstGene screen allows obstetricians to order multiple recommended prenatal genetic screens from one maternal blood sample, helping clinicians deliver more complete information earlier in pregnancy and support timely, informed conversations with patients.”

According to Towards Healthcare, the direct-to-consumer genetic testing market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 3.79 billion in 2026 to approximately USD 27.15 billion by 2035, representing a compound annual growth rate (CAGR) of 24.44% from 2026 to 2035, driven by, DTC tests has the potential to act as comparatively affordable, large-scale population health screening devices to find people who will be significantly affected by genetically-associated conditions but who may not have through contact with a health care supplier. Direct-to-consumer genetic testing offer targeted data about disease challenges, ancestry, and perticular health traits. DNA samples gathered simply at home and mailed or transported directly to the company. Direct-to-consumer genetic testing does not needed approval from a medical care provider or a health insurance organization.

About Myriad Genetics

Myriad Genetics is a leading molecular diagnostic and precision medicine organization committed to developing health and well-being for all. Myriad Genetics develops and commercializes molecular tests that supports patients and supplier uncover genetic insights. This tests assess the challenges of advancing disease or disease progression and guide management decisions in the healthcare specialties where molecular insights potentially enhance patient care, support earlier identification, allows more precise management and contribute to lessening healthcare expenses.

Myriad Genetics Safe Harbor Statement

This press release contains “forward-looking statements” within the meaning of the private securities litigation reform act of 1995, involving statements regarding the anticipated advantages, utility, and turnaround time of the FirstGene Multiple Prenatal Screen. These “forward-looking statements” are management’s expectations of future proceedings as of the date hereof and are subject to known and unknown challenges and uncertainties that could cause actual outcomes, conditions, and events to differ materially and adversely from those anticipated. Such factors involves those challenges described in the company’s filings with the U.S. Securities and Exchange Commission, involving the company’s Annual Report on Form 10-K filed on February 2026, also any updates to those risk factors filed from time to time in the organization’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not under any obligation, and it particularly disclaims any obligation, to update or alter any forward-looking declarations, whether as a result of novel data, future proceedings or otherwise except as needed by law.

A recent report by Towards Healthcare highlights that the direct-to-consumer genetic testing market is growing as DTC genetic testing offers consumers with the opportunity to learn related their genetic profiles associated to phenotypes of interest in a convenient and affordable manner. Major genetic tests performed by DTC organization are restricted to few major genetic variants associatedto the phenotypes of interest, which leads to poor discriminatory power. Direct-to-consumer genetic testing offers targeted data related disease challenges, ancestry, and specific health traits. DTC testing is an exciting addition to the traditional medical care model for consumers who want knowledge of their health status and disease challenges.