Cancer Genetics’ Unique Tissue of Origin Test Receives Special FDA 510(k) Clearance

Cancer Genetics (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, today announced that it has received special 510(k) clearance from the U. S. Food and Drug Administration (FDA) for its Tissue of Origin test following modifications made to test reagents and software.

As quoted in the press release:

“Our TOO® Test represents a unique offering with the ability to add significant value to the continuum of care for cancer patients and greatly enhance our biopharma partners’ development efforts. This 510(k) clearance represents an important milestone toward our goal of gaining broad adoption of the test,” said John A. (Jay) Roberts, Interim Chief Executive Officer and COO of Cancer Genetics. “An important element of our recently implemented transformation strategy is the identification of new methods through which to monetize our world-class test portfolio. We are currently evaluating several partnering opportunities that would expand the reach of the TOO® Test and have the potential to generate high-margin revenue streams. We look forward to continuing this process as we leverage the capabilities of TOO® to drive future growth.”

Compared to the early version, the current TOO® assay uses new labeling reagents and has a higher accuracy rate and a shorter workflow with similar precision and reproducibility. The low RNA input requirement of the early version is maintained. The combined result of these new features offers a further optimized clinical assay to help clinicians make diagnostic decisions and subsequent treatment selections.

Click here to read the full press release.