Inostics said this week that its clinical laboratory in Baltimore, Md., has received CLIA licensure, allowing it to offer its non-invasive OncoBEAM tumor mutation test.
The blood-based test is based on Beads, Emulsions, Amplification, and Magnetics, or BEAMing, technology, which combines emulsion-based digital PCR with flow cytometry. Inostics said the technology allows for the molecular analysis of tumor DNA shed from primary and metastatic tumors found circulating in a patient's blood.
"Due to the non-invasiveness and real-time reflection of tumor genetics, the OncoBEAM blood test represents a valuable tool to complement clinical decision making," Frank Diehl, CSO of Inostics, said in a statement.
Inostics is based in Hamburg, Germany and specializes in mutation detection technology.
The Medical Device Bureau of Health Canada has granted a license to Abbott to market its RealTime High Risk HPV molecular diagnostic test for detecting human papillomavirus.
The test, which was CE marked in 2008, detects 14 high-risk HPV genotypes, including HPV genotypes 16 and 18, which are known to pose the highest risk of progression to cervical cancer. About 70 percent of cervical cancer cases are found to have HPV 16 and/or 18, Abbott said.
The test runs on Abbott's m2000 RealTime molecular diagnostic system.
The US Food and Drug Administration this week approved a companion diagnostic for two drugs that treat patients with advanced or unresectable melanoma.
The FDA approved the GlaxoSmithKline drugs Tafinlar (dabrafenib) and Mekinist (trametinib) with the THxID BRAF test from BioMérieux, a PCR-based test that determines whether a patient's melanoma cells have the V600E or V600K mutation in the BRAF gene.
It is the second companion diagnostic approved by FDA for BRAF mutation detection following the August 2011 approval of Roche's Cobas 4800 BRAF V600 Mutation Test.
Approval of the BioMérieux test is based on data from clinical studies that supported the approvals of Tafinlar and Mekinist, FDA said.