Myriad Genetics' New FDA Nod For BRACAnalysis CDx Widens Base

Moving steadily with its 11-year long partnership with AstraZeneca PLC (NYSE:AZN) , Myriad Genetics, Inc. (NASDAQ:MYGN) recently announced the receipt of FDA approval for using its BRACAnalysis CDx test to identify patients having a germline BRCA mutation (gBRCAm), suffering with advanced ovarian cancer and suitable for first-line maintenance therapy with AstraZeneca’s PARP (poly ADP (NASDAQ:ADP) ribose polymerase) inhibitor — Lynparza (olaparib) — following response to platinum-based chemotherapy.

Per Myriad Genetics, the approval is based on positive results from the SOLO-1 trial. In the trial, Myriad Genetics’ BRACAnalysis CDx test recognized patients with advanced ovarian cancer who may benefit from Lynparza. According to management, the FDA’s approval highlights the requirement for all ovarian cancer patients to find out about their BRACAnalysis CDx results at the time of diagnosis. This will enable these patients to develop a proper understanding of their treatment options.

We believe the FDA approval will help in expanding the customer base and increasing top-line contributions from the BRACAnalysis CDx test.

Solid Market Prospects

Myriad Genetics is boding well to cash on the huge potential in the breast cancer screening market. Per a report by DPI Research on Medium, the breast cancer screening market in the United States is expected to reach a value of roughly $5.8 billion by 2022.

We believe that an ageing population, rising awareness and healthcare expenditures will continue to drive growth in the breast cancer screening market.

Recent Developments in BRACAnalysis

In October 2018, Myriad Genetics announced the receipt of the FDA approval for using its BRACAnalysis CDx as a companion diagnostic with Pfizer’s PARP (poly ADP ribose polymerase) inhibitor, TALZENNA (talazoparib).

The company has also entered a new laboratory services agreement with Pfizer Inc. (NYSE:PFE) Per the agreement, Myriad Genetics will make available its BRACAnalysis CDx testing in a Phase 2 study assessing Pfizer’s PARP inhibitor — talazoparib — for neo-adjuvant treatment of germline BRCA-mutated triple negative breast cancer. According to Myriad Genetics, 35,000 women are diagnosed with new cases of triple negative breast cancer annually in the United States.

Share Price Performance

Myriad Genetics has been gaining investors’ confidence from consistent positive results. In a year’s time, shares of the company have significantly outperformed its industry. The stock has lost 15.1% compared with the industry’s 24.1% decline.

Zacks Rank & Key Picks

Myriad Genetics currently has a Zacks Rank #1(Strong Buy).

Other top-ranked stocks in the broader medical space are Veeva Systems (NYSE:VEEV) and Integer Holdings Corporation (NYSE:ITGR) .

Veeva Systems’ long-term earnings growth rate is estimated at 19.5%. The stock carries a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Integer Holdings, with a Zacks Rank #2 (Buy), has an earnings growth rate of 31.2% for the first quarter of 2019.

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