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FDA Approves Qiagen CDx for Vectibix Colorectal Cancer Drug

NEW YORK (GenomeWeb) – The US Food and Drug Administration has approved Qiagen's Therascreen KRAS RGQ PCR companion test to pick out best responders to Amgen's colorectal cancer drug Vectibix (panitumumab).

Simultaneously, the agency also approved late last week Vectibix in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, for first-line treatment of patients with wild-type KRAS metastatic colorectal cancer. The latest approval converts the accelerated approval for Vectibix into full approval.

The approval of the Therascreen KRAS test for Vectibix comes after the FDA cleared the same platform in 2012 to gauge best responders to Bristol-Myers Squibb/Eli Lilly's Erbitux (cetuximab), a drug in the same class. Last year, the agency approved Qiagen's Therascreen EGFR RGQ PCR Kit to guide treatment decisions with Boehringer Ingelheim's Gilotrif (afatinib).

In Europe, Qiagen markets Therascreen assays for biomarkers including KRAS, EGFR, NRAS, BRAF, PI3K, JAK2, MGMT, and UGT1A1, and sells various companion tests in China and Japan.

The Scan

Pig Organ Transplants Considered

The Wall Street Journal reports that the US Food and Drug Administration may soon allow clinical trials that involve transplanting pig organs into humans.

'Poo-Bank' Proposal

Harvard Medical School researchers suggest people should bank stool samples when they are young to transplant when they later develop age-related diseases.

Spurred to Develop Again

New Scientist reports that researchers may have uncovered why about 60 percent of in vitro fertilization embryos stop developing.

Science Papers Examine Breast Milk Cell Populations, Cerebral Cortex Cellular Diversity, Micronesia Population History

In Science this week: unique cell populations found within breast milk, 100 transcriptionally distinct cell populations uncovered in the cerebral cortex, and more.