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Myriad Genetics Test to Identify Cancer Patients Gets FDA Nod

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Myriad Genetics, Inc. MYGN recently announced that it received the FDA approval for its myChoice CDx to be used as a companion diagnostic by medical care providers. The test will help identify women with advanced ovarian cancer, who are eligible for GlaxoSmithKline plc’s (GSK - Free Report) Zejula (niraparib) PARP Inhibitor in the late-line treatment setting.

myChoice CDx, which has been under development for quite a long time, is the first and only FDA-approved tumor test to treat cancer patients, who have received three or more prior chemotherapy cycles and whose cancer is associated with homologous recombination deficiency.

With the recent approval, the company aims to strengthen foothold in the global ovarian cancer treatment market.



Few Words on the Test

Per Myriad Genetics, myChoice CDx helps to identify the homologous recombination deficiency status by detecting BRCA1 and BRCA2 (sequencing and large rearrangement) variants, with an inclusive evaluation of genomic instability. For this, the test uses three vital biomarkers — loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions.

Significance of the Approval

In the United States, around 22,000 women are diagnosed with ovarian cancer every year, which is the fifth most frequent reason behind cancer death among women. About 85% of patients experience disease recurrence despite high response rates to platinum-based chemotherapy in the frontline treatment setting.

Over time, it becomes increasingly incurable due to frequent recurrences. There are hardly any late-line treatment options for women with ovarian cancer, with less than 10% of patients achieving an overall response after chemotherapy.

Hence, with this approval, cancer patients will likely be able to avail fast-track precision therapies.

Recent Developments

Of late, Myriad Genetics has been witnessing a slew of developments in cancer treatment.

The company announced that it collaborated with the University of Leeds in September 2019 for Personalised Medicine and Health to assess the clinical utility of the Prolaris test in men with prostate cancer. Myriad Genetics also published results of a clinical study in the same month, which proved that the Prolaris genetic test can successfully identify men with low-risk prostate cancer. This will help caregivers to chalk out appropriate treatment plans, thereby deferring the need for costly treatments with side effects.

Myriad Genetics announced receiving favorable outcomes from the AstraZeneca/Merck Phase III PROfound study in August 2019. The study met its primary endpoint and demonstrated that men with metastatic castration-resistant prostate (mCRPC) cancer responded positively to the treatment with Lynparza (olaparib), a novel PARP inhibitor.

Industry Prospects

Per a report by ResearchAndMarkets on Business Wire, the global ovarian cancer treatment market is estimated to reach $2.505 billion by 2024, witnessing a CAGR of 7.02%. The key factors driving the market are the increasing incidents of ovarian cancer among women worldwide, and the subsequent awareness and innovations to treat the disease.

Given the current market potential for tackling the disease, the approval has come at the right time.

Price Performance

The company’s shares have dipped 23.5% in the past year compared with the industry’s decline of 9.3%. However, the S&P 500 index rose 13.7% during the same period.

Zacks Rank & Key Picks

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

Some better-ranked stocks from the broader medical space are Aphria Inc APHA and Owens & Minor, Inc OMI.

Aphria, currently carrying a Zacks Rank #2 (Buy), has projected first-quarter 2020 earnings growth rate at 113.33%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Owens & Minor estimates earnings growth rate of 300% for third-quarter 2019. It currently sports a Zacks Rank #1.

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