Clinical laboratory managers and pathologists can expect more companion diagnostics in responses to advances in molecular knowledge about various diseases
Recently, the Food and Drug Administration (FDA) cleared two products for market, one of which may be of particular interest to anatomic pathologists. The first product is a therapeutic drug for the treatment of late-stage skin cancer. The second product is a companion clinical laboratory test that will be used to identify skin cancer patients most likely to benefit from this new drug.
This development is attracting attention by experts watching the molecular diagnostics marketplace. That’s because both products were developed by the same company on a tight timeline and this process is likely to be much studied by other pharma companies and genetic test developers.
The company that developed the new drug and its companion diagnostic test is Roche Holdings AG (OTCQX: RHHBY). In its press release about the FDA’s decisions, the company simultaneously announced market clearance of the drug Zelboraf (vemurafenib) and the approval of the companion diagnostic, the cobas 4800 BRAF V600 Mutation Test.