Myriad Genetics and AstraZeneca expand their companion diagnostic pact for AztraZeneca?s investigational drug candidate olaparib.
Myriad Genetics, a molecular diagnostics company, has expanded its agreement with AstraZeneca to provide companion diagnostics for olaparib, an anticancer drug candidate. Olaparib is an investigational orally active poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca treating various tumor types including BRCA-mutated breast and ovarian cancers. BRCA 1 or BRCA 2 gene mutations are responsible for the majority of hereditary breast and ovarian cancers, according to information from Myriad Genetics.
Under the expanded agreement, Myriad will build out a new laboratory within its Salt Lake City, Utah regulations for companion diagnostic devices. In August 2013, FDA approved an investigational device exemption filed by Myriad, for BRCA analysis, a propretiary gentic test by Myriad for identifying patients with BRCA 1 or BRCA 2 gene mutations to enable clinical studies with olaparib to include BRACAnalysis testing as a diagnostic.
The collaboration builds on an existing agreement through which Myriad provided supply of BRACAnalysis to support the Phase II development program for olaparib in breast and ovarian cancers.
Source: Myriad Genetics
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.