Myriad Genetics' New FDA Nod for BRACAnalysis CDx Widens Base

Various market performance charts

Moving steadily with its 11-year long partnership with AstraZeneca PLC AZN , Myriad Genetics, Inc. 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 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. 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 VEEV and Integer Holdings Corporation 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.

Today's Stocks from Zacks' Hottest Strategies

It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%.

And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.

See Them Free>>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Veeva Systems Inc. (VEEV): Free Stock Analysis Report

AstraZeneca PLC (AZN): Free Stock Analysis Report

Integer Holdings Corporation (ITGR): Free Stock Analysis Report

Myriad Genetics, Inc. (MYGN): Free Stock Analysis Report

To read this article on click here.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story


Other Topics


Latest Markets Videos


    Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at

    Learn More