A Cambridge UK BioMedTech company has won a key FDA approval in the cancer research arena for its lab in South Carolina.Lab21, whose technology advances personalised medicine research and clinical diagnostics, says its CLIA laboratory in Greenville has been named as one of only nine throughout the whole of the US to offer the first FDA approved companion diagnostic test to provide guidance for the use of Erbitux® in colorectal cancer.
Recent FDA approval of the Qiagen therascreen KRAS test, allows it to be used to determine whether patients with metastatic colorectal cancer are suitable for treatment with Erbitux. The test has been routinely used in Europe since 2008 and is the first KRAS assay to secure FDA approval.
The breakthrough gives healthcare providers an FDA approved test which provides fast, consistent and reliable data to determine optimal treatment for colorectal cancer patients who are candidates for EGFR-targeted inhibitor therapy.
Lab21 has been providing a KRAS analysis service using the assay from its CPA Accredited laboratory in Cambridge UK for both Amgen and Merck Serono since 2008. It has since performed over 6,000 tests, including patient samples originating in a number of countries in Europe and the Middle East.
Michael Bolick, President of Lab21 Inc., said: “The therascreen KRAS assay is part of our initial portfolio of molecular diagnostic tests. As the only laboratory in Qiagen’s launch group based in the south-eastern region of the US market, Lab21 is well positioned to be the first provider of this valuable service to the regional cancer community.”