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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 Mayo Clinic will develop tests to detect for the presence of alleles that increase the risk for developing the potentially deadly skin disease if certain drugs are taken.

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.

The funding will be used by Insight to develop companion diagnostics for lung cancer.

Dako will develop cancer diagnostic tests, which Quintiles will perform as part of the clinical validation.

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."

Myriad will test patients in a Phase III drug study for BRCA1 and BRCA2 mutations.

The Danish firm received FDA clearance to expand the intended use of its HercepTest and HER2 FISH pharmDx Kit to include patients with metastatic gastric or stomach cancer.

The firm is using the grants to develop tests to help oncologists predict the effectiveness of targeted cancer therapies.

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.

The program, called the Pharmacogenomic Resource for Enhanced Decisions in Care and Treatment, or PREDICT, started genetically testing cardiac patients on Sept. 15.

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.

Fluimedix is developing a diagnostic test for warfarin metabolism on the NanoCycler, its benchtop, PCR-based diagnostic platform.

Under the agreement, GlaxoSmithKline may use a DNA methylation-specific biomarker developed by OncoMethylome in its immunotherapeutics program.

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.

MPI's Drug Response Predictor pairs the company's algorithms and expertise with the Affymetrix GeneChip platform to help guide both clinical validation and patient treatment.

Findings in a NEJM study this week challenged previously reported data that alleles in the CYP2C19 gene can limit how certain carriers of the polymorphisms respond to Plavix.

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.


Nature News reports that genomics is being applied to trace and try to prevent additional COVID-19 waves.

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.

Wildlife managers aim to boost the genetic diversity of Mexican gray wolves by placing captive-born foster pups into packs with similarly aged wild pups, the Mercury News reports.

In Science this week: Genetic Probability tool identifies likely diagnoses in 45 percent of inflammatory arthritis cases, and more.