Myriad Genetics, Inc. MYGN announced the receipt of reimbursement and the subsequent launch of the BRACAnalysis Diagnostic System in Japan. Notably, the system can be utilized by physicians to identify whether people, who already have breast and ovarian cancer, have Hereditary Breast and Ovarian Cancer (“HBOC”) syndrome, thus qualifying for additional diagnostic and medical management.
Notably, Japan’s Ministry of Health, Labour and Welfare (“MHLW”) approved BRACAnalysis for the indication in November 2019. Further, the system was approved as a companion diagnostic for Lynparza (olaparib) in women with ovarian cancer in February 2019. In March 2018, it was approved as a companion diagnostic for Lynparza in patients with metastatic inoperable or recurrent breast cancer.
With the recent boost, Myriad Genetics aims to strengthen its Molecular Diagnostic Testing arm globally.
Significance of the Reimbursement Receipt
Per the Japan medical fraternity, the availability of BRACAnalysis significantly boosts their efforts to assess HBOC risk in people with breast and ovarian cancer. This, in turn, will simplify the identification of patients with BRCA mutations, who might require more advanced diagnostic and medical care. Physicians can order the BRACAnalysis test for affected patients, meeting the defined genetic testing criteria, effective immediately.
Per Myriad Genetics’ estimates, more than 25,000 people in Japan are currently eligible for genetic testing. Notably, the company collaborated with SRL, a subsidiary of Miraca Group, to commercialize BRACAnalysis in Japan. Myriad Genetics claims that since BRACAnalysis is the best available option at present for germline BRCA1 and BRCA2 testing globally, the partnership will enable it to provide wider test accessibility to the patients in Japan.
Per a report by Grand View Research, the global molecular diagnostics market size was valued at $9.2 billion in 2019 and is expected to reach $18.2 billion by 2027, witnessing a CAGR of 9%. Factors like growing prevalence of infectious diseases and technological advancements in molecular diagnostics are expected to drive the rally.
Given the market potential, the reimbursement receipt and the subsequent launch of the testing system are expected to be a major growth driver.ss
Recent Developments in Molecular Diagnostic Testing
Of late, Myriad Genetics has been witnessing a slew of developments in its business arm.
The company submitted a supplementary application with the MHLW for its BRACAnalysis in March. The application was regarding the use of the BRACAnalysis as a companion diagnostic to help in the identification of people with metastatic pancreatic or metastatic castration-resistant prostate cancer, having germline BRCA1 and BRCA2 mutations. Such people are potential candidates for targeted therapy with the PARP inhibitor, Lynparza (olaparib), subject to regulatory approval.
In February, Myriad Genetics announced the presentation of its study, where it was established that Prolaris precisely predicts which men with intermediate or high-risk prostate cancer will benefit from multi-modality therapy and which can avoid unnecessary treatment. Further, in the same month, the company submitted a supplementary premarket approval application (sPMA) to the FDA for its myChoice CDx test based on favorable study outcome from the Phase 3 PAOLA-1 trial of Lynparza. The test helps to identify women with advanced ovarian cancer, who are potential candidates for maintenance therapy with Lynparza (olaparib) in combination with bevacizumab.
In January, the company submitted a sPMA to the FDA for its myChoice CDx test to help predict outcomes of women with first-line platinum responsive advanced ovarian cancer treated with GlaxoSmithKline plc’s GSK PARP inhibitor Zejula (niraparib). The filing was made on the basis of the positive results from the Phase 3 PRIMA trial of Zejula. Further, in January, Myriad Genetics submitted a sPMA to the FDA for its BRACAnalysis CDx test as a companion diagnostic to AstraZeneca’s and Merck’s PARP inhibitor Lynparza (olaparib) for men with metastatic castration-resistant prostate cancer.
Shares of the company have fallen 53.3% in the past year compared with the industry’s 11.5% decline.
Zacks Rank & Key Picks
Currently, Myriad Genetics carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are ResMed Inc. RMD and National Vision Holdings, Inc. EYE.
ResMed has a projected long-term earnings growth rate of 14.4%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
National Vision’s long-term earnings growth rate is estimated at 10.7%. The company presently has a Zacks Rank #2.
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