Myriad Genetics Publishes Analytical Validation of FirstGene Multiple Prenatal Screen
Myriad Genetics announced the publication of the analytical validation of the FirstGene Multiple Prenatal Screen in Clinical Chemistry. The study showed that each component of the test had exceptional sensitivity and specificity. Titled "Simultaneous prenatal cfDNA screening of aneuploidy, recessive single-gene conditions, and fetomaternal blood compatibility," the study used nearly 500 samples to assess the multiple components of the FirstGene screen, including fetal aneuploidy testing, RhD compatibility, and recessive condition status in the pregnant person and fetus, including 19 prevalent and severe conditions. It found that every component of the test had greater than or equal to98.2% analytical sensitivity and greater than or equal to99.0% analytical specificity.
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- Significant Revenue Growth: Myriad Genetics reported fourth-quarter revenue of $209.8 million, exceeding the high end of the pre-announced range, indicating strong performance in high-growth market segments that is likely to boost future investments and market confidence.
- Sustained Test Volume Increase: MyRisk tests achieved a year-over-year volume growth of 14% in the affected market and 11% in the unaffected market, demonstrating the company's expanding market share in oncology, which enhances its competitive edge.
- New Product Launch Plans: Management outlined plans to launch multiple new products in 2026, including an expanded MyRisk panel and AI-enhanced Prolaris prostate cancer test, which are expected to enrich the product portfolio and drive future revenue growth.
- 2026 Financial Outlook: The company reaffirmed its revenue guidance for 2026 at $860 million to $880 million, with an adjusted gross margin of 68%-69%, reflecting confidence in future growth while also showcasing a keen awareness of market dynamics.
- Earnings Beat: Myriad Genetics reported a Q4 non-GAAP EPS of $0.04, exceeding expectations by $0.06, indicating robust profitability that boosts investor confidence in the company's financial health.
- Slight Revenue Decline: The Q4 revenue stood at $209.8 million, a 0.4% year-over-year decrease, yet it surpassed expectations by $2.24 million, demonstrating the company's ability to maintain revenue stability in a competitive landscape.
- Volume Growth Drivers: Key drivers of year-over-year test volume growth in Q4 included a 12% increase in Prolaris prostate cancer testing, a 9% rise in hereditary cancer testing, and a 9% growth in GeneSight, reflecting ongoing innovation and demand in precision medicine.
- Stable Gross Margin: The gross margin for Q4 was 70.0%, consistent with Q3, showcasing effective cost management and operational efficiency that support long-term profitability prospects.
- Earnings Announcement Date: Myriad Genetics (MYGN) is set to announce its Q4 fiscal year 2023 earnings on February 23 after market close, with a consensus EPS estimate of -$0.02, reflecting a significant year-over-year decline of 166.7%, indicating pressure on profitability.
- Revenue Expectations Decline: The revenue estimate for the quarter stands at $207.56 million, down 1.4% year-over-year, highlighting challenges the company faces amid intensified market competition and demand fluctuations, which may impact investor confidence moving forward.
- Historical Performance Metrics: Over the past two years, MYGN has exceeded EPS and revenue estimates 88% of the time, although recent trends show no upward revisions in EPS estimates and three downward revisions, suggesting a cautious outlook from analysts regarding the company's future performance.
- Revision Trend Analysis: While there have been two upward revisions in revenue estimates, there have also been three downward revisions, indicating a conservative market sentiment towards Myriad Genetics' growth prospects, which could affect its stock price performance.
- Validation Results: Myriad Genetics' publication on the FirstGene Multiple Prenatal Screen shows that every test component achieved ≥98.2% analytical sensitivity and ≥99.0% analytical specificity, indicating exceptional accuracy and reliability in prenatal screening, which enhances clinicians' confidence in the results.
- Clinical Application Outlook: The test evaluated nearly 500 samples, covering fetal aneuploidy, RhD compatibility, and 19 severe recessive conditions, aiming to streamline prenatal genetic risk assessment by integrating multiple testing modalities, thereby improving screening rates among pregnant women in the U.S. and enhancing clinical practices.
- Technological Innovation: The FirstGene screen employs fetal-fraction amplification and a novel trajectory analysis algorithm to enhance genotype resolution, which not only improves test accuracy but also marks a significant milestone towards broad commercialization of prenatal screening technologies by Myriad.
- CONNECTOR Study Launch: The FirstGene screen is currently utilized in the CONNECTOR study, designed to evaluate test performance in real-world clinical settings, generating evidence to support clinical validity and utility as FirstGene advances towards full commercial launch.
- Earnings Call Scheduled: Myriad Genetics will hold its Q4 and full year 2025 earnings conference call on February 23, 2026, at 4:30 PM ET, releasing its quarterly earnings the same day, which is expected to impact investor confidence positively.
- Investor Conference Participation: Executives Sam Raha and Ben Wheeler will participate in several investor healthcare conferences, including the TD Cowen Annual Healthcare Conference on March 3 and the Leerink Partners Global Healthcare Conference on March 10, aimed at enhancing the company's visibility and credibility among investors.
- Webcast Accessibility: Investors can access live and archived webcasts of the earnings call on Myriad's Investor Relations website, which enhances transparency and provides convenient information access, likely attracting more potential investors.
- Leadership in Genetic Testing: Myriad Genetics focuses on genetic testing and precision medicine, aiming to improve patient care quality and reduce healthcare costs through disease risk assessment and treatment guidance, further solidifying its leadership position in the industry.







