Myriad Genetics Receives Approval for New Test in Japan
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
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Should l Buy MYGN?
Source: Newsfilter
- Test Expansion: Myriad Genetics' MyChoice® Test has been approved by Japan's Ministry of Health, Labour and Welfare as a companion diagnostic for Lynparza®, marking a significant milestone for the company in the Japanese market and is expected to enhance its market share in precision medicine.
- Patient Benefits: This approval allows clinicians to order MyChoice testing for prostate cancer patients to determine homologous recombination deficiency (HRD) status, potentially providing new testing options for over 100,000 newly diagnosed prostate cancer patients annually in Japan, thereby improving treatment decision-making accuracy.
- Insurance Coverage: The reimbursement approval for MyChoice testing now includes prostate cancer patients, and the addition of tumor-based testing alongside existing BRCA1/2 testing is expected to expand the number of patients who may benefit from PARP inhibitor treatments, further driving the company's cancer care product portfolio.
- Technical Advantage: The MyChoice Test offers comprehensive HRD testing through a composite of three proprietary technologies, enabling physicians to identify patients more susceptible to DNA-damaging drugs, which aligns with the company's strategic goal of advancing precision medicine while potentially lowering healthcare costs.
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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: 5.190
Low
4.00
Averages
7.38
High
9.00
Current: 5.190
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 to Present New Research at AACR Annual Meeting
- Research Presentation: Myriad Genetics will present six abstracts at the 2026 AACR Annual Meeting, including two key podium presentations that showcase the exceptional performance of its Precise MRD test in breast cancer treatment, potentially influencing personalized treatment decisions.
- Clinical Trial Data: New results from the MONITOR-Breast study will be presented on April 20 by Dr. Julia Foldi from the University of Pittsburgh Medical Center, revealing that frequent MRD testing during neoadjuvant therapy can provide clear insights into patient response patterns, aiding clinicians in optimizing treatment plans.
- Technological Innovation: Myriad's Precise MRD test employs whole genome sequencing technology with ultra-high sensitivity, enabling monitoring of circulating tumor DNA levels throughout a patient's cancer care journey, thereby enhancing the accuracy and timeliness of clinical decision-making.
- Industry Impact: Myriad Genetics' participation in the AACR meeting not only highlights its leadership in the molecular diagnostics field but also has the potential to attract more biopharma partnerships, advancing drug development and clinical applications.
See More
Myriad Genetics Receives Approval for New Test in Japan
- Test Expansion: Myriad Genetics' MyChoice® Test has been approved by Japan's Ministry of Health, Labour and Welfare as a companion diagnostic for Lynparza®, marking a significant milestone for the company in the Japanese market and is expected to enhance its market share in precision medicine.
- Patient Benefits: This approval allows clinicians to order MyChoice testing for prostate cancer patients to determine homologous recombination deficiency (HRD) status, potentially providing new testing options for over 100,000 newly diagnosed prostate cancer patients annually in Japan, thereby improving treatment decision-making accuracy.
- Insurance Coverage: The reimbursement approval for MyChoice testing now includes prostate cancer patients, and the addition of tumor-based testing alongside existing BRCA1/2 testing is expected to expand the number of patients who may benefit from PARP inhibitor treatments, further driving the company's cancer care product portfolio.
- Technical Advantage: The MyChoice Test offers comprehensive HRD testing through a composite of three proprietary technologies, enabling physicians to identify patients more susceptible to DNA-damaging drugs, which aligns with the company's strategic goal of advancing precision medicine while potentially lowering healthcare costs.
See More
Myriad Genetics Presents New Data at SGO Annual Meeting
- Research Presentation: Myriad Genetics will showcase four research findings at the SGO Annual Meeting from April 10-13, including two oral presentations and two posters, underscoring the company's commitment to cancer care and the significance of the data shared.
- Precise MRD Testing: The latest Precise MRD™ data indicates that the recurrence risk for ovarian cancer patients post-adjuvant therapy is significantly correlated with ctDNA levels, highlighting the test's critical clinical implications for monitoring recurrence risk.
- Large-Scale Research Registry: The Myriad Collaborative Research Registry™ includes de-identified data from over 1.3 million participants, revealing that the prevalence of pathogenic variants in ovarian cancer patients is associated with age and ancestry, providing vital insights for clinical decision-making.
- Advantages of Genetic Screening: The studies show that universal hereditary cancer screening identifies more individuals at high risk for endometrial cancer compared to age-based screening, demonstrating Myriad's strategic value in advancing early cancer detection and precision treatment.
See More
Myriad Genetics Under Investigation for Possible Securities Fraud
- Securities Fraud Investigation: The Portnoy Law Firm has initiated an investigation into Myriad Genetics, potentially filing a class action on behalf of investors to recover losses due to corporate financial issues, with investors encouraged to contact the firm for legal rights information.
- Stock Price Plunge: Myriad's stock price plummeted by $3.00, or 41.3%, closing at $4.27 per share on May 7, 2025, directly harming investors and reflecting severe market concerns regarding the company's financial health.
- Declining Financial Performance: The Q1 2025 financial results revealed total revenue of $196 million, a 3% year-over-year decline, with a notable 20% drop in pharmacogenomics revenue attributed to UnitedHealthcare reducing coverage for GeneSight®, leading to lowered future earnings guidance.
- Severe Market Reaction: The combination of lost insurance coverage for a key product and downward revisions of future earnings expectations resulted in extreme market volatility, indicating a significant lack of investor confidence in Myriad's future prospects.
See More
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
VERTIV HOLDINGS, LUMENTUM HOLDINGS, COHERENT, AND ECHOSTAR SET TO ENTER S&P 500
New Additions to S&P 500: Vertiv Holdings, Lumentum Holdings, Coherent, and Echosstar are set to join the S&P 500 index.
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
Myriad Genetics to Present New Research at AACR Annual Meeting
- Research Presentation: Myriad Genetics will present six abstracts at the 2026 AACR Annual Meeting, including two key podium presentations that showcase the exceptional performance of its Precise MRD test in breast cancer treatment, potentially influencing personalized treatment decisions.
- Clinical Trial Data: New results from the MONITOR-Breast study will be presented on April 20 by Dr. Julia Foldi from the University of Pittsburgh Medical Center, revealing that frequent MRD testing during neoadjuvant therapy can provide clear insights into patient response patterns, aiding clinicians in optimizing treatment plans.
- Technological Innovation: Myriad's Precise MRD test employs whole genome sequencing technology with ultra-high sensitivity, enabling monitoring of circulating tumor DNA levels throughout a patient's cancer care journey, thereby enhancing the accuracy and timeliness of clinical decision-making.
- Industry Impact: Myriad Genetics' participation in the AACR meeting not only highlights its leadership in the molecular diagnostics field but also has the potential to attract more biopharma partnerships, advancing drug development and clinical applications.
See More
Myriad Genetics Receives Approval for New Test in Japan
- Test Expansion: Myriad Genetics' MyChoice® Test has been approved by Japan's Ministry of Health, Labour and Welfare as a companion diagnostic for Lynparza®, marking a significant milestone for the company in the Japanese market and is expected to enhance its market share in precision medicine.
- Patient Benefits: This approval allows clinicians to order MyChoice testing for prostate cancer patients to determine homologous recombination deficiency (HRD) status, potentially providing new testing options for over 100,000 newly diagnosed prostate cancer patients annually in Japan, thereby improving treatment decision-making accuracy.
- Insurance Coverage: The reimbursement approval for MyChoice testing now includes prostate cancer patients, and the addition of tumor-based testing alongside existing BRCA1/2 testing is expected to expand the number of patients who may benefit from PARP inhibitor treatments, further driving the company's cancer care product portfolio.
- Technical Advantage: The MyChoice Test offers comprehensive HRD testing through a composite of three proprietary technologies, enabling physicians to identify patients more susceptible to DNA-damaging drugs, which aligns with the company's strategic goal of advancing precision medicine while potentially lowering healthcare costs.
See More
Myriad Genetics Presents New Data at SGO Annual Meeting
- Research Presentation: Myriad Genetics will showcase four research findings at the SGO Annual Meeting from April 10-13, including two oral presentations and two posters, underscoring the company's commitment to cancer care and the significance of the data shared.
- Precise MRD Testing: The latest Precise MRD™ data indicates that the recurrence risk for ovarian cancer patients post-adjuvant therapy is significantly correlated with ctDNA levels, highlighting the test's critical clinical implications for monitoring recurrence risk.
- Large-Scale Research Registry: The Myriad Collaborative Research Registry™ includes de-identified data from over 1.3 million participants, revealing that the prevalence of pathogenic variants in ovarian cancer patients is associated with age and ancestry, providing vital insights for clinical decision-making.
- Advantages of Genetic Screening: The studies show that universal hereditary cancer screening identifies more individuals at high risk for endometrial cancer compared to age-based screening, demonstrating Myriad's strategic value in advancing early cancer detection and precision treatment.
See More
Myriad Genetics Under Investigation for Possible Securities Fraud
- Securities Fraud Investigation: The Portnoy Law Firm has initiated an investigation into Myriad Genetics, potentially filing a class action on behalf of investors to recover losses due to corporate financial issues, with investors encouraged to contact the firm for legal rights information.
- Stock Price Plunge: Myriad's stock price plummeted by $3.00, or 41.3%, closing at $4.27 per share on May 7, 2025, directly harming investors and reflecting severe market concerns regarding the company's financial health.
- Declining Financial Performance: The Q1 2025 financial results revealed total revenue of $196 million, a 3% year-over-year decline, with a notable 20% drop in pharmacogenomics revenue attributed to UnitedHealthcare reducing coverage for GeneSight®, leading to lowered future earnings guidance.
- Severe Market Reaction: The combination of lost insurance coverage for a key product and downward revisions of future earnings expectations resulted in extreme market volatility, indicating a significant lack of investor confidence in Myriad's future prospects.
See More
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
VERTIV HOLDINGS, LUMENTUM HOLDINGS, COHERENT, AND ECHOSTAR SET TO ENTER S&P 500
New Additions to S&P 500: Vertiv Holdings, Lumentum Holdings, Coherent, and Echosstar are set to join the S&P 500 index.
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
