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Myriad Genetics' BRACAnalysis Test Platform Gets PMA in Japan
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Myriad Genetics, Inc. (MYGN - Free Report) recently announced the receipt of manufacturing and marketing approval for its BRACAnalysis Diagnostic System from the Japanese Ministry of Health, Labour, and Welfare. The system can now be used as a companion diagnostic with the PARP inhibitor, Lynparza,
Following the approval, physicians in Japan are now authorized to prescribe BRACAnalysis to patients diagnosed with metastatic breast cancer to find out if they carry germline BRCA1 or BRCA2 gene mutations. We encouragingly note that, BRACAnalysis is the first and only diagnostic test for a PARP inhibitor to be approved in Japan.
Furthermore, Myriad Genetics has formed an exclusive partnership with the SRL Inc. to market BRACAnalysis in Japan. Notably, subsidiary of Miraca Group, SRL is one of the largest laboratory service providers in Japan.
Meanwhile, AstraZeneca and Merck, the marketers of Lynparza, are looking forward to getting approval for treating patients with BRCA-mutated metastatic breast cancer in Japan.
Recent Developments in BRACAnalysis
Myriad Genetics has been leaving no stone unturned to boost the uptake of BRACAnalysis test. The company markets this product in the United States as BRACAnalysis CDx. In January, Myriad Genetics had 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.
Again, last 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.
Market Potential
Per Myriad Genetics, about 40,000 patients with metastatic disease are currently eligible for BRACAnalysis testing in Japan. Moreover, approximately 15,000 new cases of HER2-negative breast cancer are diagnosed each year. This promising data indicates what a timely and strategic role the latest approval is going to play in favor of Myriad Genetics.
Share Price Performance
Myriad Genetics has been gaining investors’ confidence on consistently positive results. Over the past year, the company’s share price has outperformed the broader industry. The stock has gained 59.7%, in contrast to the broader industry’s 7.2% fall.
Zacks Rank & Key Picks
Myriad Genetics carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical sector are Bio-Rad Laboratories (BIO - Free Report) , athenahealth, Inc. and Align Technology, Inc. (ALGN - Free Report) .
athenahealth is a Zacks #1 Ranked player. It has long-term expected earnings growth rate of 21.5%.
Align Technology has long-term expected earnings growth rate of 29.2%. The stock carries a Zacks Rank of 2 (Buy).
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Image: Bigstock
Myriad Genetics' BRACAnalysis Test Platform Gets PMA in Japan
Myriad Genetics, Inc. (MYGN - Free Report) recently announced the receipt of manufacturing and marketing approval for its BRACAnalysis Diagnostic System from the Japanese Ministry of Health, Labour, and Welfare. The system can now be used as a companion diagnostic with the PARP inhibitor, Lynparza,
Following the approval, physicians in Japan are now authorized to prescribe BRACAnalysis to patients diagnosed with metastatic breast cancer to find out if they carry germline BRCA1 or BRCA2 gene mutations. We encouragingly note that, BRACAnalysis is the first and only diagnostic test for a PARP inhibitor to be approved in Japan.
Furthermore, Myriad Genetics has formed an exclusive partnership with the SRL Inc. to market BRACAnalysis in Japan. Notably, subsidiary of Miraca Group, SRL is one of the largest laboratory service providers in Japan.
Meanwhile, AstraZeneca and Merck, the marketers of Lynparza, are looking forward to getting approval for treating patients with BRCA-mutated metastatic breast cancer in Japan.
Recent Developments in BRACAnalysis
Myriad Genetics has been leaving no stone unturned to boost the uptake of BRACAnalysis test. The company markets this product in the United States as BRACAnalysis CDx. In January, Myriad Genetics had 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.
Again, last 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.
Market Potential
Per Myriad Genetics, about 40,000 patients with metastatic disease are currently eligible for BRACAnalysis testing in Japan. Moreover, approximately 15,000 new cases of HER2-negative breast cancer are diagnosed each year. This promising data indicates what a timely and strategic role the latest approval is going to play in favor of Myriad Genetics.
Share Price Performance
Myriad Genetics has been gaining investors’ confidence on consistently positive results. Over the past year, the company’s share price has outperformed the broader industry. The stock has gained 59.7%, in contrast to the broader industry’s 7.2% fall.
Zacks Rank & Key Picks
Myriad Genetics carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical sector are Bio-Rad Laboratories (BIO - Free Report) , athenahealth, Inc. and Align Technology, Inc. (ALGN - Free Report) .
Bio-Rad Laboratories sports a Zacks Rank of 1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. It has long-term expected earnings growth rate of 20%.
athenahealth is a Zacks #1 Ranked player. It has long-term expected earnings growth rate of 21.5%.
Align Technology has long-term expected earnings growth rate of 29.2%. The stock carries a Zacks Rank of 2 (Buy).
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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