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"The fact is that Pathway's bold move to make themselves noticed achieved its end and brought them to our attention," an FDA official told Pharmacogenomics Reporter.

The FDA said that in expanding its DTC genomics service from the internet to Walgreens, Pathway Genomics "has moved outside of the currently sanctioned boundaries for laboratory-developed tests."

In the study, Amgen researchers and academic collaborators used the Roche 454 Life Sciences platform to sequence nine genes in 320 tumor samples from a clinical trial of the EGFR inhibitor Vectibix. It represents one of the first applications of next-gen sequencing to characterize samples from a clinical trial.

Although Qiagen is prioritizing Rx/Dx partnerships with pharma, that doesn't mean it won't look into bringing tests to market with payors or on its own.

After missing the first-to-market opportunities with KRAS, both Merck KGaA and Amgen are strategically looking into additional gene markers, with the likely aim of being able to launch companion tests to their drugs that are more sensitive and accurate than the competition.

Parker, a principal scientist in Amgen's Molecular Sciences group, spoke with In Sequence about the role of next-generation sequencing in his work, and where he sees a place for emerging sequencing technologies at Amgen.

Decode is hoping to incorporate the recently discovered SNP on chromosome 4p16 into a multi-gene panel test for UBC, according to Decode's Kari Stefansson.

When Vectibix received approval from the US Food and Drug Administration in 2006, "Amgen already knew the response rate was low," according to an Amgen official. The company began collecting patient tissue samples from mid-2005 to early 2007, knowing it would "need those samples for a biomarker analysis."

"DxS is seeking to avoid its exclusive obligation with Roche because it no longer finds it advantageous to benefit from the Roche distribution network," but a termination of the agreement would cause "irreparable" harm, Roche stated in a recently filed complaint.

Most DTC genomic service providers use either custom or catalog chips made by the two West Coast vendors, though some vow to integrate next-gen sequencing into their services when cost and reliability issues improve.

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A South African university has told the Wellcome Sanger Institute to return DNA samples it has from indigenous African communities, The Times reports.

The University of California, Berkeley's Rasmus Nielsen and Xinzhu Wei have retracted their CCR5 gene paper due to a technical artifact.

 

University of Virginia researchers are exploring a genetic risk test to gauge type 1 diabetes risk, NPR reports.

In PNAS this week: researchers compare two high-grade neuroendocrine lung cancers, height among ancient Europeans, and more.