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Inostics' Blood-Based Mutation Testing Receives CLIA Certification

Date: Jun-04-2013
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).
Courtesy: Medical News Today
Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.