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Published on April 4, 2019
Myriad Genetics said today it has expanded its companion diagnostic collaboration with AstraZeneca and Merck & Co., which have agreed to use Myriad’s BRACAnalysis CDx to identify men with a type of prostate cancer in a Phase III trial. BRACAnalysis CDx will be used to identify germline BRCA mutations in…
Published on March 14, 2019
Myriad Genetics said today it has received a final local coverage determination for its myPath Melanoma test from the Medicare Administrative Contractor Palmetto GBA MolDx. myPath Melanoma is designed to help physicians provide a definitive diagnosis when a suspicious skin lesion is equivocal based upon histopathology, according to Myriad. “We…
Published on October 17, 2024
Physicians will now be able to order Myriad Genetics’ MyRisk® Hereditary Cancer Test and view the results of the test directly in Flatiron Health’s cloud-based electronic medical record (EMR) platform, OncoEMR. MyRisk is the first hereditary cancer test to be incorporated into Flatiron’s OncoEMR. Myriad is a genetic testing pioneer,…
Published on November 2, 2022
Myriad Genetics announced on Tuesday that it acquired consumer-focused prenatal and pediatric genomic test developer Gateway Genomics for $67.5 million in cash. The deal could pay Gateway an additional an additional $32.5 million of cash payments in 2023 and 2024 if certain revenue, volume synergy and EBITDA targets are achieved.…
Published on March 14, 2022
Myriad Genetics today launched Precise Oncology Solutions, a new suite of tests that combines germline testing, tumor profiling, and companion diagnostic options including evaluation for Homologous Recombination Deficiency (HRD), an important cancer repair pathway. The suite includes Myriad’s new Precise Tumor Molecular Profile Test, developed in collaboration with Intermountain Precision…
Published on December 30, 2019
Myriad Genetics’ BRACAnalysis CDx The FDA has approved Myriad Genetics’ BRACAnalysis CDx test as a companion diagnostic for the latest indication of Lynparza (olaparib) authorized by the agency. The poly ADP-ribose polymerase (PARP) inhibitor, which is co-marketed by AstraZeneca and Merck & Co., has won additional…
Published on November 21, 2019
Myriad Genetics said today that its BRACAnalysis Diagnostic System has won a third regulatory approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) that will allow physicians to determine which women with breast cancer are at risk of having Hereditary Breast and Ovarian Cancer (HBOC) syndrome—and thus eligible for…
Published on November 5, 2019
Shares of Myriad Genetics fell more than 40% on Tuesday, after the molecular diagnostics developer lowered its earnings guidance for its current fiscal year and reported lower-than-expected quarterly revenue that its CEO blamed on this year’s change in Current Procedural Terminology (CPT) codes covering hereditary cancer testing for two genes.…
Published on October 24, 2019
The FDA has approved Myriad Genetics’ myChoice CDx as a companion diagnostic for Zejula (niraparib) to identify women with advanced ovarian cancer in the late-line treatment setting—an indication added by the agency to its approved uses for the poly ADP-ribose polymerase (PARP) inhibitor marketed by GlaxoSmithKline (GSK). The FDA’s approval…
Published on October 7, 2019
Since the completion of the Human Genome Project in 2003, the pharmacogenomics industry has experienced waxes and wanes in reaction to healthcare dynamics and technological advancements.[i] With the continued push towards personalized medicine, pharmacogenetics offers organizations a potential solution to fine-tune therapy by helping predict the patient’s response to a…
Published on September 16, 2019
Myriad Genetics said today it will assess the clinical utility of its Prolaris test in men diagnosed with prostate cancer, through a collaboration with the Leeds Centre for Personalised Medicine and Health (LCPMH) whose value was not disclosed. Myriad and LCPMH plan to partner on a study designed to evaluate the…
Published on August 7, 2019
Myriad Genetics said today it will pursue FDA authorization of its BRACAnalysis CDx test as a companion diagnostic for the AstraZeneca/Merck & Co. co-marketed drug Lynparza (olaparib) in metastatic castration-resistant prostate cancer (mCRPC) patients with germline mutations of the BRCA gene. Myriad said its decision to file a supplementary Premarket…
Published on October 16, 2018
The FDA today approved Myriad Genetics’ BRACAnalysis CDx as a companion diagnostic for Pfizer’s poly ADP-ribose polymerase (PARP) inhibitor Talzenna (talazoparib), which has also won agency approval. The approval allows healthcare professionals to use BRACAnalysis CDx to identify patients with HER2-negative metastatic breast cancer (mBC) who have a germline BRCA…
Published on May 29, 2018
Myriad Genetics said today it will acquire Counsyl for $375 million in cash and stock, in a deal designed to expand the buyer’s presence in women’s health genetic testing. Myriad said the acquisition will enable the company to position itself as a single source of genetic tests for the 40,000…
Published on April 2, 2018
Myriad Genetic Laboratories, a wholly-owned subsidiary of Myriad Genetics, announced that the Japanese Ministry of Health, Labour, and Welfare has granted manufacturing and marketing approval for Myriad's BRACAnalysis Diagnostic System (BRACAnalysis) to be used as a companion diagnostic with the PARP inhibitor Lynparza, known as MSD outside the United States…