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"If approved by the FDA, the DxS TheraScreen: K-RAS Mutation Kit would become a companion diagnostic for use with Erbitux in metastatic colorectal cancer to determine which patients have wild-type KRAS status in the US," DxS said this week.

The companies aim to offer the K-RAS mutation companion test to US markets.

Following the GWAS, researchers plan to conduct a prospective, randomized-controlled trial and form a pharmacogenomics consortium specifically focused on validating and discovering new gene-response variants for clopidogrel.

A team of scientists led by researchers at the University of Maryland Medical School reports today in JAMA that CYP2C19*2 influences Plavix treatment response as well as the frequency of coronary problems in those at higher risk of such events.

In order to make the labeling change, the agency reviewed retrospective data from seven clinical trials. But this is the exception, according to one official from a diagnostic company who believes FDA's lengthy deliberations have further nudged drug companies to advance diagnostics at the same time as therapeutics in prospective studies.

The FDA has updated the drugs' labels to note that "retrospective analyses of metastatic colorectal cancer trials have not shown a treatment benefit for the EGFR inhibitors in patients whose tumors had KRAS mutations in codon 12 or 13" and that the use of the drugs is not recommended for the treatment of colorectal cancer patients with these mutations.

Without PGx-guided dosing information, it is unclear whether genetic testing to gauge Plavix response will go the same way as genetic testing for warfarin. At least one national insurer, Aetna, feels that the FDA did not provide enough information in the updated label to warrant coverage for the intervention.

At a March meeting with industry groups, the FDA gathered comments regarding the barriers to drug/diagnostic codevelopment and noted the agency might issue a series of white papers on the topic.

The company also released its fourth-quarter financial results, posting higher losses on increased research and development spending as it worked to move its first drug into the clinic this year.

The FDA has confirmed to DxS that its TheraScreen KRAS test is a Class III device. The company is in the process of submitting its premarket approval application to the agency.

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Public health experts call for a transparent COVID-19 vaccine approval process in a letter; the Food and Drug Administration commissioner assures science-based approval.

The Verge reports that new gene-naming guidelines aim in part to avoid Excel-related name change confusion.

In Nature this week: tuatara genome sequence aids in understanding amniote evolution, and more.

According to the Guardian, UK virologists say in a letter to officials that their expertise has been pushed aside in COVID-19 response plans.