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Myriad Genetics (MYGN) Gets Extensive Coverage for BRACAnalysis

Myriad Genetics, Inc. MYGN recently received expanded coverage from Japan’s Ministry of Health, Labour and Welfare (MHLW) for using BRACAnalysis Diagnostic System as a companion diagnostic. The system detects patients with germline BRCA-mutated (gRBCAm) and HER2 negative high-risk recurrent breast cancer who stand to gain from Lynparza (olaparib). This expanded coverage will enable more breast cancer patients to qualify for BRCA1/2 testing in Japan.

Per management at Myriad Genetics, the latest coverage expansion confirms the benefits of leveraging biomarkers to guide care for breast cancer patients.

Few Words on Lynparza

The Lynparza is jointly developed and commercialized by AstraZeneca and MSD Inc. The collaboration between Myriad Genetics and AstraZeneca on olaparib began in 2007 and has led to prior regulatory authorizations in the United States and Japan.

The Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS) during the OlympiA trial. It has been shown to lower the risk of invasive breast cancer recurrences, new cancers, or death.

A Detailed View on BRACAnalysis

The BRACAnalysis Diagnostic System categorizes a patient’s clinically significant variants (DNA sequence variations) in the germline BRCA1 and BRCA2 genes. It detects deleterious or suspected deleterious germline BRCA variants in patients with HER2-negative high-risk early breast cancer. Post classification, the test findings are sent to medical personnel in Japan for determining diagnostic and therapeutic patient management decisions.

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The BRACAnalysis has been demonstrated to be an effective test for patients deciding their best course of treatment, based on data from the OlympiA Phase III trial and other clinical studies.

Industry Prospects

Per a report by Mordor Intelligence, the breast cancer therapy market is expected to see a CAGR of 8.3% during 2021-2026. The increasing burden of breast cancer, growing investments in R&D and advancements in cancer biology and pharmacology promoting drug development can be attributable to market growth.

Given the market prospects, the latest MHLW-approval of BRACAnalysis as a companion diagnostic for Lynparza seems well-timed.

Other Notable Developments

In Aug 2022, Myriad Genetics formed two partnerships with the Institutfür Hämopathologie Hamburg (HPH) in Hamburg, Germany and the Centre Georges-Francois LeClerc (CGFL) in Dijon, France, to broaden access to MyChoiceCDx Plus testing. The MyChoiceCDx Plus is a CE-IVD-marked companion diagnostic test that evaluates Homologous Recombination Deficiency (HRD) status in ovarian cancer patients. HPH and CGFL have teamed up with Myriad Genetics to support equitable patient access to genetic testing in major European markets.

In June 2022, the company partnered with a renowned healthcare software company, Epic, to integrate its full line of genetic tests with the latter’s expansive network of 600,000 physicians and over 250 million patients. This integration will enable healthcare providers to order Myriad tests and review results directly within their everyday Epic platform. This collaboration is expected to fortify Myriad Genetics’ growth plan to scale customer-centric, tech-enabled commercial capabilities with more than 600 EHR integrations in 2022.

Share Price Performance

The stock has outperformed its industry over the year. It has declined 34.3% compared with the industry’s 40.2% fall.

Zacks Rank and Key Picks

Currently, Myriad Genetics carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical space that investors can consider are AMN Healthcare Services, Inc. AMN, Patterson Companies, Inc. PDCO and McKesson Corporation MCK.

AMN Healthcare has a long-term earnings growth rate of 3.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 15.7%, on average. It currently flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

AMN Healthcare has outperformed its industry in the past year. AMN has lost 6% against the industry’s 34.9% fall.

Patterson Companies has an estimated long-term growth rate of 7.9%. The company’s earnings surpassed estimates in all the trailing four quarters, the average beat being 16.5%. It currently flaunts a Zacks Rank #2 (Buy).

Patterson Companies has outperformed its industry in the past year. PDCO has lost 5.1% compared with the industry’s 12.4% fall in the past year.

McKesson has an estimated long-term growth rate of 9.9%. The company surpassed earnings estimates in the trailing three quarters and missed in one, delivering a surprise of 13%, on average. It currently carries a Zacks Rank #2.

McKesson has outperformed its industry in the past year. MCK has gained 77.3% against the industry’s 12.4% fall.

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