Inostics, a molecular diagnostics company that provides blood-based mutation testing, received CLIA (Clinical Laboratory Improvement Amendments) licensure for its clinical laboratory located in Baltimore, MD. This marks a critical milestone for the clinical adoption of this non-invasive molecular approach for the analysis of tumor biomarkers.
“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. We are extremely excited to be able to bring this solution to cancer patients as OncoBEAM tests offer a significant enhancement to clinical care over traditional tissue-based molecular testing,” Dr. Frank Diehl, CSO of Inostics, said.
The OncoBEAM blood test is based on BEAMing technology which combines emulsion based digital PCR with flow cytometry. This technology enables the molecular analysis of tumor DNA shed from primary and metastatic tumors, found circulating in the blood of patients.
Due to its non-invasiveness, OncoBEAM blood tests introduce new possibilities for the management of various cancers like skin, colorectal, breast, and lung cancer. Now a simple blood draw can support clinical decision making in the context of therapy selection, assessment of drug response, resistance and recurrence monitoring, and detection of minimal residual disease (MRD).