Representatives from Novartis Molecular Diagnostics and Sanofi Pasteur weighed in on the increasing use of quantitative PCR in areas such as companion diagnostic development and vaccine analytical testing at an industry meeting this week.
Early studies involving a monoclonal antibody against PCSK9 show promise in lowering LDL in hypercholesterolemia patients. According to at least one published study, Pfizer is investigating assay methods for monitoring treatment response by gauging PCSK9 levels.
The study found that when doctors and their patients were educated about PGx-guided dosing for warfarin and tamoxifen in a pharmacy-initiated personalized medicine program, the testing rate increased 45-fold for warfarin and seven-fold for tamoxifen.
Although some industry observers suggest that Boehringer Ingelheim's newly FDA-approved anticoagulant spells the end for PGx-guided warfarin dosing, some still see opportunities where warfarin administration, made more accurate with genetic testing, may be a better option for patients.
Although several studies have shown that carriers of CYP2C19 alleles do not respond to Plavix as well as non-carriers, and the FDA has updated the drug's label to notify physicians of the role of these alleles in Plavix metabolism, the assay's label specifically notes that "the INFINITI CYP2C19 Assay is not intended to be used to predict drug response or non-response."
Cepheid will receive $5 million in an upfront payment and $3 million in milestone payments over the next 12 months as part of the deal, while Novartis would have exclusive global distribution rights to the test upon its commercialization in the US.
Although OncoMethylome could not disclose the specific drug development program for which its DNA methylation-specific PCR biomarker will be used, GSK's pipeline offers some hints as to the specific immunotherapeutic involved.
At an industry conference last week, a scientific reviewer at FDA's Office of In Vitro Diagnostics Device Evaluation and Safety discussed detailed strategies for navigating the regulatory process for Rx/Dx combination products.
The first available test on the system, for the CYP2C19*2 mutation that guides how patients metabolize the anti-coagulant Plavix, is currently in a clinical trial in Canada. The company expects that data from the study will help support regulatory filings around the world for the platform.
Rady's Children Hospital and San Diego County are teaming up to test pediatric patients and their families for COVID-19 to gauge the spread of the virus locally, according to the San Diego Union-Tribune.