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Molecular diagnostics firm Inostics receives CLIA certification

Inostics, a molecular diagnostics firm providing blood-based mutation testing, has received the Clinical Laboratory Improvement Amendments (CLIA) license for its clinical laboratory in Baltimore.

The receipt of the license would mark a milestone for the adoption of non-invasive molecular approach in analysing tumor biomarkers.

Inostics CSO Frank Diehl said that 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," Diehl added.

The OncoBEAM blood test is based on BEAMing technology that combines emulsion based digital PCR with flow cytometry.

The technology allows the molecular analysis of tumor DNA shed from primary and metastatic tumors, found circulating in the blood of patients.

OncoBEAM blood test introduces newly managed possibilities due to its non-invasiveness for various types of cancers like skin, colorectal, breast, and lung.

A blood sample helps in making decisions with regard to therapy selection, assessing drug response, monitoring resistance and recurrence and detection of minimal residual disease (MRD).