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Myriad Genetics Fortifies Molecular Diagnostics With FDA Nod
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Myriad Genetics, Inc. (MYGN - Free Report) recently announced the receipt of FDA approval for BRACAnalysis CDx test for usage as a companion diagnostic with AstraZeneca and Merck’s PARP inhibitor Lynparza (olaparib) in patients with HER2-negative metastatic breast cancer (MBC) and germline BRCA mutation.
In October 2017, the company had announced the FDA’s acceptance of supplementary premarket approval (sPMA) application for BRACAnalysis CDx for usage as a companion diagnostic with AstraZeneca's PARP inhibitor Lynparza (olaparib) in patients with HER2-negative MBC. Per management, on approval, the test will be available for around 125,000 patients who are unaware of their BRCA status out of the 155,000 patients with MBC in the United States.
Recent Developments in BRACAnalysis CDx
Myriad Genetics has been leaving no stone unturned to boost the uptake of BRACAnalysis CDx test. In December, the company presented encouraging data from the EMBRACA trial demonstrating the BRACAnalysis CDx test’s ability to effectively identify patients with MBC who responded to Pfizer's investigational PARP inhibitor, talazoparib. The EMBRACA trial covered roughly 400 patients who were tested positive for germline BRCA mutations as determined by the BRACAnalysis CDx test.
Also, as a companion diagnostic to olaparib for the treatment of HER2- MBC cancer patients, BRACAnalysis CDx has been submitted in Japan for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by the Ministry of Health, Labor and Welfare. Per the company, this approval will help cash in on a market opportunity of more than 10,000 patients per year.
Myriad Genetics has also received a sPMA for BRACAnalysis CDx in March 2017. Post-approval, BRACAnalysis CDx is being used as a complementary diagnostic test in ovarian cancer patients associated with improved progression free survival (PFS) when used with Tesaro’s PARP inhibitor Zejula (niraparib) maintenance therapy.
Market Potential
Myriad Genetics has been consistently trying to strengthen its hold in the high-potential 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 also encouragingly note that Myriad Genetics has been consistently trying to expand in the high-potential molecular diagnostics market, which is expected to reach a value of around $10.12 billion at a CAGR of 9.1% between 2016 and 2021 (per a report by MarketsandMarkets).
Share Price Performance
Myriad Genetics has been gaining investor confidence on consistently positive results. Over the past six months, the company’s share price has outperformed the broader industry. The stock has gained 46%, in contrast to the broader industry’s 2.1% fall.
Zacks Rank & Key Picks
Myriad Genetics carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical sector are Amedisys, Inc. (AMED - Free Report) , Bio-Rad Laboratories, Inc. (BIO - Free Report) and Intuitive Surgical, Inc. (ISRG - Free Report) .
Amedisys has a long-term expected earnings growth rate of 18.5%. The stock carries a Zacks Rank #2 (Buy).
Intuitive Surgical has a long-term expected earnings growth rate of 9.2%. The stock carries a Zacks Rank #2.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
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Myriad Genetics Fortifies Molecular Diagnostics With FDA Nod
Myriad Genetics, Inc. (MYGN - Free Report) recently announced the receipt of FDA approval for BRACAnalysis CDx test for usage as a companion diagnostic with AstraZeneca and Merck’s PARP inhibitor Lynparza (olaparib) in patients with HER2-negative metastatic breast cancer (MBC) and germline BRCA mutation.
In October 2017, the company had announced the FDA’s acceptance of supplementary premarket approval (sPMA) application for BRACAnalysis CDx for usage as a companion diagnostic with AstraZeneca's PARP inhibitor Lynparza (olaparib) in patients with HER2-negative MBC. Per management, on approval, the test will be available for around 125,000 patients who are unaware of their BRCA status out of the 155,000 patients with MBC in the United States.
Recent Developments in BRACAnalysis CDx
Myriad Genetics has been leaving no stone unturned to boost the uptake of BRACAnalysis CDx test. In December, the company presented encouraging data from the EMBRACA trial demonstrating the BRACAnalysis CDx test’s ability to effectively identify patients with MBC who responded to Pfizer's investigational PARP inhibitor, talazoparib. The EMBRACA trial covered roughly 400 patients who were tested positive for germline BRCA mutations as determined by the BRACAnalysis CDx test.
Also, as a companion diagnostic to olaparib for the treatment of HER2- MBC cancer patients, BRACAnalysis CDx has been submitted in Japan for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by the Ministry of Health, Labor and Welfare. Per the company, this approval will help cash in on a market opportunity of more than 10,000 patients per year.
Myriad Genetics has also received a sPMA for BRACAnalysis CDx in March 2017. Post-approval, BRACAnalysis CDx is being used as a complementary diagnostic test in ovarian cancer patients associated with improved progression free survival (PFS) when used with Tesaro’s PARP inhibitor Zejula (niraparib) maintenance therapy.
Market Potential
Myriad Genetics has been consistently trying to strengthen its hold in the high-potential 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 also encouragingly note that Myriad Genetics has been consistently trying to expand in the high-potential molecular diagnostics market, which is expected to reach a value of around $10.12 billion at a CAGR of 9.1% between 2016 and 2021 (per a report by MarketsandMarkets).
Share Price Performance
Myriad Genetics has been gaining investor confidence on consistently positive results. Over the past six months, the company’s share price has outperformed the broader industry. The stock has gained 46%, in contrast to the broader industry’s 2.1% fall.
Zacks Rank & Key Picks
Myriad Genetics carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical sector are Amedisys, Inc. (AMED - Free Report) , Bio-Rad Laboratories, Inc. (BIO - Free Report) and Intuitive Surgical, Inc. (ISRG - Free Report) .
Bio-Rad Laboratories flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. The company has a long-term expected earnings growth rate of 25%.
Amedisys has a long-term expected earnings growth rate of 18.5%. The stock carries a Zacks Rank #2 (Buy).
Intuitive Surgical has a long-term expected earnings growth rate of 9.2%. The stock carries a Zacks Rank #2.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X 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>>