We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Myriad Genetics (MYGN) to Offer Companion Diagnostic for Lynparza
Read MoreHide Full Article
Myriad Genetics, Inc. (MYGN - Free Report) recently announced the receipt of FDA approval for its BRACAnalysis CDx test for use as a companion diagnostic to detect germline BRCA-mutated (gRBCAm) variants in patients with HER2 negative high-risk early-stage breast cancer who stand to gain from Lynparza (olaparib). It is worth noting that AstraZeneca and MSD Inc are commercializing Lynparza.
The collaboration between Myriad Genetics and AstraZeneca on olaparib began in 2007 and has led to FDA authorizations of the BRACAnalysis CDx for ovarian cancer patients and those with HER2 negative metastatic breast cancer. The latest regulatory approval affirms the benefits of utilizing biomarkers to guide the care process for breast cancer patients.
Per management, the recent advancement highlights the need for screening breast cancer patients for approved therapies by determining their BRCA status with an FDA-approved test post-diagnosis.
More on the News
The BRACAnalysis CDx classifies a patient’s clinically significant variants (DNA sequence variations) in the germline BRCA1 and BRCA2 genes. After the completion of classification, the results are sent to medical personnel to determine whether the patient is eligible for treatment with Lynparza.
The results from the OlympiA trial as well as several other clinical studies demonstrate the efficacy of the BRACAnalysis CDx test in aiding patients choose their best treatment options. In the OlympiA trial, patients suffering from HER2 negative early-stage breast cancer who also had BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants, and high-risk clinicopathological factors exhibited a statistically significant and clinically meaningful improvement with longer survival, free of invasive or distant disease.
Image Source: Zacks Investment Research
The Breast International Group, in collaboration with the Frontier Science & Technology Research Foundation, NRG Oncology, the US National Cancer Institute, AstraZeneca and MSD, is leading the OlympiA Phase III trial.
Industry Prospects
Per a report published in Mordor Intelligence, the breast cancer therapy market is expected to see a CAGR of 8.3% during 2021-2026. Factors such as increasing burden of breast cancer, growing investments in R&D and advancements in cancer biology and pharmacology promoting drug development are likely to fuel market growth.
Given the market prospects, the latest FDA approval of BRACAnalysis CDx as a companion diagnostic for olaparib seems well-timed.
Other Notable Developments
During the fourth quarter of 2021, Myriad Genetics’ total testing volumes reflected a 13% improvement on a year-over-year basis (excluding divested businesses), with prenatal test volumes in Women's Health growing 4% year over year and pharmacogenomics test volumes in Mental Health increasing 63% year over year.
In the last-reported quarter, the company also saw robust revenue growth from companion diagnostics, including significant revenue share from its proprietary myChoice CDx test. In its fourth-quarter earnings update, Myriad Genetics announced plans to expand its market-leading FDA-approved companion diagnostic test, MyChoice CDx, to other indications like breast, prostate and pancreatic cancers for expanded pharma clinical trials and commercial testing.
Share Price Performance
The stock has outperformed its industry over the year. It has declined 15.7% compared with the industry’s 39.4% fall.
Zacks Rank and Key Picks
Currently, Myriad Genetics carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space are Henry Schein, Inc. (HSIC - Free Report) , McKesson Corporation (MCK - Free Report) and AmerisourceBergen Corporation .
Henry Schein has an estimated long-term growth rate of 11.8%. Henry Schein’s earnings surpassed estimates in the trailing four quarters, the average surprise being 25.5%. It carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Henry Schein has outperformed the industry over the past year. HSIC has gained 23.4% compared with the industry’s 1.6% rise over the past year.
McKesson has a long-term earnings growth rate of 11.8%. McKesson’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 20.6%, on average. It carries a Zacks Rank #2.
McKesson has outperformed the industry over the past year. MCK has gained 48.9% against a 1.6% industry growth in the said period.
AmerisourceBergen has a long-term earnings growth rate of 8.2%. In the trailing four quarters, AmerisourceBergen’s earnings surpassed estimates in three and missed in one, delivering an average surprise of 2.3%. The stock currently sports a Zacks Rank #2.
AmerisourceBergen has outperformed its industry in the past year, gaining 26.9% versus the industry’s 1.5% rise.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Myriad Genetics (MYGN) to Offer Companion Diagnostic for Lynparza
Myriad Genetics, Inc. (MYGN - Free Report) recently announced the receipt of FDA approval for its BRACAnalysis CDx test for use as a companion diagnostic to detect germline BRCA-mutated (gRBCAm) variants in patients with HER2 negative high-risk early-stage breast cancer who stand to gain from Lynparza (olaparib). It is worth noting that AstraZeneca and MSD Inc are commercializing Lynparza.
The collaboration between Myriad Genetics and AstraZeneca on olaparib began in 2007 and has led to FDA authorizations of the BRACAnalysis CDx for ovarian cancer patients and those with HER2 negative metastatic breast cancer. The latest regulatory approval affirms the benefits of utilizing biomarkers to guide the care process for breast cancer patients.
Per management, the recent advancement highlights the need for screening breast cancer patients for approved therapies by determining their BRCA status with an FDA-approved test post-diagnosis.
More on the News
The BRACAnalysis CDx classifies a patient’s clinically significant variants (DNA sequence variations) in the germline BRCA1 and BRCA2 genes. After the completion of classification, the results are sent to medical personnel to determine whether the patient is eligible for treatment with Lynparza.
The results from the OlympiA trial as well as several other clinical studies demonstrate the efficacy of the BRACAnalysis CDx test in aiding patients choose their best treatment options. In the OlympiA trial, patients suffering from HER2 negative early-stage breast cancer who also had BRCA1 or BRCA2 germline pathogenic or likely pathogenic variants, and high-risk clinicopathological factors exhibited a statistically significant and clinically meaningful improvement with longer survival, free of invasive or distant disease.
Image Source: Zacks Investment Research
The Breast International Group, in collaboration with the Frontier Science & Technology Research Foundation, NRG Oncology, the US National Cancer Institute, AstraZeneca and MSD, is leading the OlympiA Phase III trial.
Industry Prospects
Per a report published in Mordor Intelligence, the breast cancer therapy market is expected to see a CAGR of 8.3% during 2021-2026. Factors such as increasing burden of breast cancer, growing investments in R&D and advancements in cancer biology and pharmacology promoting drug development are likely to fuel market growth.
Given the market prospects, the latest FDA approval of BRACAnalysis CDx as a companion diagnostic for olaparib seems well-timed.
Other Notable Developments
During the fourth quarter of 2021, Myriad Genetics’ total testing volumes reflected a 13% improvement on a year-over-year basis (excluding divested businesses), with prenatal test volumes in Women's Health growing 4% year over year and pharmacogenomics test volumes in Mental Health increasing 63% year over year.
In the last-reported quarter, the company also saw robust revenue growth from companion diagnostics, including significant revenue share from its proprietary myChoice CDx test. In its fourth-quarter earnings update, Myriad Genetics announced plans to expand its market-leading FDA-approved companion diagnostic test, MyChoice CDx, to other indications like breast, prostate and pancreatic cancers for expanded pharma clinical trials and commercial testing.
Share Price Performance
The stock has outperformed its industry over the year. It has declined 15.7% compared with the industry’s 39.4% fall.
Zacks Rank and Key Picks
Currently, Myriad Genetics carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space are Henry Schein, Inc. (HSIC - Free Report) , McKesson Corporation (MCK - Free Report) and AmerisourceBergen Corporation .
Henry Schein has an estimated long-term growth rate of 11.8%. Henry Schein’s earnings surpassed estimates in the trailing four quarters, the average surprise being 25.5%. It carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Henry Schein has outperformed the industry over the past year. HSIC has gained 23.4% compared with the industry’s 1.6% rise over the past year.
McKesson has a long-term earnings growth rate of 11.8%. McKesson’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 20.6%, on average. It carries a Zacks Rank #2.
McKesson has outperformed the industry over the past year. MCK has gained 48.9% against a 1.6% industry growth in the said period.
AmerisourceBergen has a long-term earnings growth rate of 8.2%. In the trailing four quarters, AmerisourceBergen’s earnings surpassed estimates in three and missed in one, delivering an average surprise of 2.3%. The stock currently sports a Zacks Rank #2.
AmerisourceBergen has outperformed its industry in the past year, gaining 26.9% versus the industry’s 1.5% rise.