Transgenomic announced this week that it has signed an agreement with Amgen to develop an IVD test to identify NRAS and KRAS mutated patients with advanced colorectal cancer using its RAScan kits.
The test is already available as an LDT through Transgenomic's CLIA lab and should be available soon in Europe under a CE mark. The company is also planning on offering a research-use only kit version of the test in the US.
In 2009, the US Food and Drug Administration updated the labeling for Amgen's Vectibix (panitumumab) — and Bristol-Myers Squibb's Erbitux (cetuximab), another EGFR-inhibiting drug — to note that patients with certain KRAS mutations will not respond to these therapies.
Transgenomic declined to provide details on whether the RAScan test is planned as a companion diagnostic to Vectibix, or other colorectal cancer drugs in development, but said it would announce additional details once a commercial kit version is available.
The new test covers both KRAS and NRAS mutations. In a sequencing study to identify genes beyond KRAS that might also influence patients' response to Vectibix, Amgen previously found the NRAS mutations may also be predictive of response to the drug (PGx 4/21/2010).
A Transgenomic representative told PGx Reporter in an email that the RAScan technology is the "most sensitive available for detection of RAS mutations," and that it detects a broader range of mutations than traditional Sanger sequencing methods or tests like Qiagen's KRAS therascreen kit.
Amgen previously collaborated with Qiagen to advance its therascreen kit as an FDA-approved companion test for Vectibix (PGx Reporter 9/2/2009). That test hasn't yet received the agency's okay.
Qiagen also developed a companion test for Erbitux and received FDA approval for that assay last year (PGx Reporter 7/11/2012). At the time, the company said it had also submitted a PMA for the therascreen test as a companion to Amgen's Vectibix.
Transgenomic did not provide any details on when it plans to file for FDA approval of its RAScan test as an IVD in the US or other information about its plans with Amgen to advance the test commercially.