Myriad Genetics announced that it has completed the analytical validation of its FirstGene Multiple Prenatal Screen, a single‑blood‑draw test that simultaneously screens for fetal aneuploidy, RhD compatibility, and 19 severe recessive conditions. The study, published in Clinical Chemistry on February 19, 2026, evaluated nearly 500 samples and demonstrated analytical sensitivity of at least 98.2% and analytical specificity of at least 99.0% for each component.
The validation confirms the test’s ability to detect a broad range of genetic abnormalities with high accuracy, supporting the company’s plan to launch the product in the first half of 2026. FirstGene builds on Myriad’s existing prenatal portfolio, including the Prequel test, and is designed to streamline care by combining multiple screening modalities into one assay. The test employs fetal‑fraction amplification and a novel trajectory analysis algorithm to enhance detection performance.
The milestone brings FirstGene closer to commercial availability and strengthens Myriad’s position in the prenatal diagnostics market, where integrated screening solutions are increasingly sought by clinicians and payers. The validation results provide a key evidence base that will support reimbursement discussions and market adoption once the product is launched.
Management emphasized the strategic importance of the launch. President and CEO Sam Raha said the introduction of FirstGene in a large clinical study is “meaningful progress towards expanding our prenatal portfolio and represents an important growth opportunity for Myriad.” He also highlighted the company’s focus on “unlocking Myriad Genetics’ potential by implementing a compelling strategy” and “immediate steps to reduce overall expenditures while prioritizing investment in new product development and programs intended to drive revenue growth.”
Analysts note that the validation supports Myriad’s broader strategy to expand its prenatal portfolio and strengthen its competitive position. The company’s focus on integrated screening solutions aligns with market demand for streamlined, high‑accuracy tests, and the strong performance metrics position FirstGene as a compelling addition to its product line.
The company plans to launch FirstGene in the first half of 2026, a timeline supported by the validation, though some analysts suggest commercial rollout may extend into the second half of 2026. The validation provides the evidence base needed for reimbursement discussions and market adoption.
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