ImClone

EGFR has emerged as a primary area of interest in cancer research, with biopharmaceuticals like Imclone's Erbitux and Amgen's Vectibix targeting the protein, but its multiple isoforms have made it difficult to predict these drugs' effectiveness, said Yale professor Nita Maihle.

Genomic Health discussed the status of its ongoing work with Pfizer in renal cancer and suggested it might eventually develop a companion test for Erbitux that gauges mutations "beyond KRAS."

The firms will use Molecular Templates' Direct Select Platform to create Engineered Toxin Bodies libraries that will be screened to identify potential drug candidates.

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.

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."

Since the FDA's 2005 preliminary concept paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance. A new white paper from the Personalized Medicine Coalition points out the areas requiring additional regulatory and evidentiary clarity from the agency.

At a meeting hosted by the Partners HealthCare Center for Personalized Genetic Medicine last month, the events leading up to the re-labeling for colorectal cancer drugs Vectibix and Erbitux sparked discussion among participants about what Amgen and Bristol-Myers Squibb/ImClone knew about the drugs and when.

Just because the sponsors performed genomic analyses on samples collected during previously completed trials doesn't mean "they went on a fishing expedition," said FDA's Lawrence Lesko, discussing the agency's re-labeling of Vectibix and Erbitux with gene-response data.

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A fire at a Manchester hospital may have destroyed lab equipment and data, the Guardian reports.

Researchers generate a genetic database from skeletal remains from the 1845 Franklin Expedition to the Arctic, Live Science reports.

Researchers in China have begun another trial using CRISPR/Cas9 approaches in cancer patients, according to the Wall Street Journal.

In Science this week: human DNA found in sediments from archeological sites lacking bones, and more.