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Pfizer has previously touted PF-02341066 as "the first agent in clinical development that selectively targets a unique genetic feature of cancer cells." The drug is currently in Phase III trials, while Abbott is in the process of designing validating trials for a companion test with the capability to detect ALK gene rearrangements.

"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 company has begun a clinical trial for its Progensa PCA3 assay, enrolling 500 men who have had a negative prostate biopsy. The study is slated to complete in less than a year, at which point the company expects to submit its PMA to the FDA.

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.

By instituting a prior notification policy and placing Myriad in charge of determining which patients get tested, United Healthcare can monitor more closely which of its policy holders are receiving testing on BRACAnalysis.

The assays measure biomarkers — NGAL and KIM-1 — that the company said will help drug developers gauge the right dose for drugs in Phase I trials, validate proof-of-concept in Phase II, and confirm efficacy and safety in Phase III studies by helping avoid kidney damage in participants.

"I can go on and on and on about the silliness of randomized-controlled trials that are often required to demonstrate the value of diagnostics," Felix Frueh, vice president of research and development of personalized medicine at Medco, said during a conference last week.

OIVD Director Alberto Gutierrez acknowledged that the dual regulatory pathway — through CMS under the Clinical Laboratory Improvement Amendments and through the FDA — creates "an uneven playing field" for diagnostics developers.

Despite a report that Novartis intends to resubmit its application for the painkiller Prexige to the US Food and Drug Administration with a companion genetic test, the Swiss drugmaker says it is not trying to relaunch the drug in the US market.

Dako's HER-2 tests may be used as companion diagnostics for Herceptin in treating stomach cancer.

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President Donald Trump announced the US would be leaving the World Health Organization, NBC News reports.

A study of Great Danes homes in on a genomic region linked to fearfulness.

CDC head says a new analysis indicates earlier testing wouldn't have caught viral spread, NPR reports.

In PLOS this week: gene expression and epigenetics of Indonesian populations, hookworm parasite secretome, and more.