Myriad Genetics' MyChoice CDx Test Approved by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 17 2026
0mins
Should l Buy MYGN?
Myriad Genetics announced that the FDA has approved the MyChoice CDx Test as the companion diagnostic for Zejula, a PARP inhibitor from GSK, for patients with advanced ovarian cancer. This approval is based on final data from the PRIMA trial, where the MyChoice CDx Test determined homologous recombination deficiency status and was used to stratify advanced ovarian cancer patients.
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Analyst Views on MYGN
Wall Street analysts forecast MYGN stock price to rise
5 Analyst Rating
2 Buy
2 Hold
1 Sell
Hold
Current: 4.590
Low
4.00
Averages
7.38
High
9.00
Current: 4.590
Low
4.00
Averages
7.38
High
9.00
About MYGN
Myriad Genetics, Inc. is a genetic testing and precision medicine company. The Company develops and offers genetic tests that help assess the risk of developing disease or disease progression and guide treatment decisions across medical specialties where genetic insights can significantly improve patient care and lower healthcare costs. The Company is focused on three key areas where it has specialized products, capabilities, and expertise: Oncology, Women's Health, and Mental Health. In oncology, it offers testing for patients who have cancer and companion diagnostic tests that work with corresponding drugs and treatments. It also offers the SneakPeek Early Gender DNA Test, which can reveal a baby's gender as early as six weeks into pregnancy. The Company’s testing products include MyRisk, BRACAnalysis, BRACAnalysis CDx, MyChoice CDx, Prolaris, Foresight, Prequel, Precis Tumor, Precise Liquid, SneakPeek and GeneSight, among others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Myriad Genetics Receives FDA Approval for MyChoice CDx Test
- FDA Approval: Myriad Genetics' MyChoice CDx Test has received FDA approval as a companion diagnostic for GSK's Zejula, based on final data from the PRIMA trial, ensuring precise treatment decisions for advanced ovarian cancer patients.
- Critical Data Support: The MyChoice CDx Test was used in the PRIMA trial to determine homologous recombination deficiency (HRD) status, with nearly half of women with advanced ovarian cancer being HRD-positive, highlighting the importance of accurate identification.
- Market Leadership: The MyChoice CDx Test is now the only FDA-approved companion diagnostic for Zejula in the U.S., utilizing next-generation sequencing to assess BRCA1/2 genes and tumor genomic instability scores, further solidifying Myriad's leadership in ovarian cancer diagnostics.
- Personalized Treatment Outlook: The FDA decision marks a significant milestone for Myriad in precision medicine, expanding its role in personalized cancer care and ensuring treatment decisions are guided by robust genomic insights.
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- Market Growth Drivers: CEO Samraat Raha highlighted that Q4 test results reached 382,000, with MyRisk in oncology growing at 14% year-over-year and MyRisk for unaffected individuals at 11%, demonstrating robust demand in high-growth market segments.
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Myriad Genetics Receives FDA Approval for MyChoice CDx Test
- FDA Approval: Myriad Genetics' MyChoice CDx Test has received FDA approval as a companion diagnostic for GSK's Zejula, based on final data from the PRIMA trial, ensuring precise treatment decisions for advanced ovarian cancer patients.
- Critical Data Support: The MyChoice CDx Test was used in the PRIMA trial to determine homologous recombination deficiency (HRD) status, with nearly half of women with advanced ovarian cancer being HRD-positive, highlighting the importance of accurate identification.
- Market Leadership: The MyChoice CDx Test is now the only FDA-approved companion diagnostic for Zejula in the U.S., utilizing next-generation sequencing to assess BRCA1/2 genes and tumor genomic instability scores, further solidifying Myriad's leadership in ovarian cancer diagnostics.
- Personalized Treatment Outlook: The FDA decision marks a significant milestone for Myriad in precision medicine, expanding its role in personalized cancer care and ensuring treatment decisions are guided by robust genomic insights.
See More
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Market Impact: The inclusion of these companies may influence market dynamics and investor strategies as they become part of a major stock index.
See More
VERTIV HOLDINGS, LUMENTUM HOLDINGS, COHERENT, AND ECHOSTAR TO BE ADDED TO S&P 500; ADDITIONAL COMPANIES TO ENTER S&P 100, S&P MIDCAP 400, AND S&P SMALLCAP 600
New Additions to S&P 500: Vert Holdings, Lumentum Holdings, CohereNT, and EchoStar are set to join the S&P 500 index.
Other Index Changes: Additional companies will be added to the S&P 100, S&P MidCap 400, and S&P SmallCap 600 indices.
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- AMD and Meta Partnership: AMD has signed a multi-year deal with Meta to supply up to 6 gigawatts of GPUs, which is expected to significantly enhance AMD's market share in AI data centers; while the deal's cost remains unclear, it includes a performance-based warrant potentially involving up to 160 million shares of AMD stock.
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- Hims & Hers Disappoints: Shares of Hims & Hers Health fell nearly 7% after the company projected first-quarter revenues between $600 million and $625 million, significantly below the $653 million expected by analysts, with adjusted EBITDA also falling short of estimates, highlighting challenges ahead.
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Keysight Technologies Quarterly Earnings Beat Estimates
- Strong Earnings Performance: Keysight Technologies reported earnings per share of $2.17, exceeding Wall Street's expectation of $2, demonstrating robust profitability that boosts investor confidence.
- Significant Revenue Growth: The quarterly revenue reached $1.6 billion, surpassing the analyst consensus of $1.54 billion, indicating successful business expansion and strong market demand, further solidifying its market position.
- Stock Price Surge: Keysight's shares jumped 16.8% to $286.03 in pre-market trading, reflecting a positive investor reaction to the company's financial performance, which may attract more investor interest.
- Market Dynamics Impact: Keysight's strong results could influence the performance of other related stocks, particularly in the technology and electronics sectors, signaling an overall improvement in market sentiment.
See More
Myriad Genetics Surges 24% After Earnings Beat and 2026 Revenue Target of $860M-$880M
- Earnings Beat: Myriad Genetics reported a non-GAAP EPS of $0.04 for Q4 2025, exceeding expectations by $0.06, with revenue of $209.8 million surpassing forecasts by $2.24 million, indicating strong growth potential in the cancer care sector.
- 2026 Revenue Target: The company has set a revenue target of $860 million to $880 million for 2026, with Q1 2026 revenue expected to range from $200 million to $203 million, reflecting a 2% to 4% growth despite challenges in year-over-year comparisons.
- Market Growth Drivers: CEO Samraat Raha highlighted that Q4 test results reached 382,000, with MyRisk in oncology growing at 14% year-over-year and MyRisk for unaffected individuals at 11%, demonstrating robust demand in high-growth market segments.
- Challenges and Strategies: While facing challenges in recovering prenatal testing volumes, management is actively rebuilding affected accounts to ensure future revenue growth, expressing confidence in sustaining high single-digit growth rates into 2027 and beyond.
See More
