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Myriad's BRACAnalysis Wins HBOC Risk Assessment Nod In Japan

Published 11/24/2019, 09:03 PM
Updated 07/09/2023, 06:31 AM

Myriad Genetics, Inc. (NASDAQ:MYGN) recently announced that the Japanese Ministry of Health, Labour and Welfare has approved the company’s BRACAnalysis Diagnostic System for HBOC (Hereditary breast-ovarian cancer syndromes) risk assessment. Following this nod, physicians in Japan can now identify if the patients with breast cancer have HBOC syndrome and accordingly, qualify for additional medical management.

BRACAnalysis is a genetic test that identifies germline BRCA1 or BRCA2 gene mutations. We encouragingly note that BRACAnalysis is the first and the only diagnostic test for a PARP inhibitor to be approved in Japan.

The latest approval of BRACAnalysis for HBOC risk assessment in Japan will further validate the superior standard of the BRACAnalysis Diagnostic System, globally.

Moreover, Myriad Genetics entered into an exclusive partnership with SRL Inc. to market BRACAnalysis in Japan. This subsidiary of Miraca Group is one of the largest laboratory service providers in Japan.

BRACAnalysis’ Earlier Breakthroughs in Japan

In February 2019, BRACAnalysis was approved in Japan as a companion diagnostic for Lynparza (olaparib) pertaining to women with ovarian cancer.

In March 2018, BRACAnalysis was approved as a companion diagnostic for Lynparza in relation to patients with metastatic inoperable or recurrent breast cancer. Post this nod, physicians in Japan were authorized to prescribe BRACAnalysis for patients diagnosed with metastatic breast cancer to detect if they carry germline BRCA1 or BRCA2 gene mutations.

Fortifying its foothold internationally, the company is steadily receiving a satisfactory response to its BRACAnalysis CDx in Japan for addressing metastatic breast cancer. In this regard, it secured a Japanese approval for BRACAnalysis CDx as the companion diagnostic to treat first-line ovarian cancer with olaparib.

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Market Potential

The company is optimistic about the scope of BRACAnalysis in Japan considering that every year, roughly 22,000 cancer patients across the Land of the Rising Sun are eligible for companion diagnostic testing.

This promising data indicates that this latest approval is timely and a strategic fit to play in favor of Myriad Genetics.

Share Price Performance

Myriad Genetics has been gaining investors’ confidence on consistently positive results. Over the past three months, shares of the company have outperformed its industry. The stock has gained 11.5% compared with its industry’s 7.9% rise.

Zacks Rank & Key Picks

Myriad Genetics carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the broader medical space are Haemonetics Corporation (NYSE:HAE) , NuVasive, Inc (NASDAQ:NUVA) and ResMed Inc (NYSE:RMD) .

Haemonetics has a Zacks Rank #2 and a projected long-term earnings growth rate of 13.5%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

NuVasive’s long-term earnings growth rate is expected at 10.9%. The company currently has a Zacks Rank of 2.

ResMed’s long-term earnings growth rate is estimated at 12.9%. The stock is currently Zacks #2 Ranked.

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ResMed Inc. (RMD): Free Stock Analysis Report

Haemonetics Corporation (HAE): Free Stock Analysis Report

NuVasive, Inc. (NUVA): Free Stock Analysis Report

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

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