Cancer Genetics’ (NASDAQ:CGIX) long-suffering bulls finally have reason to celebrate: The FDA has granted 510(k) clearance to its Tissue of Origin test (TOO®) following modifications made to test reagents and software. CGIX shares reacted to the news, skyrocketing nearly 65%, as of this writing.
TOO® is a microarray-based gene expression test that analyzes a tumor’s genomic information to help identify its origin, which is valuable in classifying metastatic, poorly differentiated, or undifferentiated cancers. TOO® assesses 2,000 individual genes, covering 15 of the most common tumor types (representing 58 morphologies) and 90% of all solid tumors . These tumors include thyroid, breast, non-small cell lung, pancreas, gastric, colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma, melanoma, ovarian, sarcoma, testicular germ cell, and prostate.
TOO® is the only FDA-cleared test of its type and is Medicare-reimbursed. It is also the only test that provides a pathologist’s review and interpretation of a patient’s test results and diagnosis. TOO® provides extensive analytical and clinical validation for statistically significant improvement in accuracy over other methods, including IHC . TOO® results lead to a change in patient treatment 65% of the time. In challenging cancers that require a second round of IHC, TOO® increases diagnostic accuracy and confidence in site-specific treatment decisions .
Here’s what Interim CEO John A. (Jay) Roberts had to say about the approval:
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 […] 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.
CMO Rita Shaknovich added:
Despite increasing excellence in the diagnostic workup for malignancies, there are approximately 150,000 newly diagnosed cases of metastatic cancer with unclear diagnosis in the U.S. and Europe each year . This includes the subset of patients with cancers of unknown primary (CUP) and of uncertain origin. Increasingly complex algorithms and testing associated with a diagnostic workup also means that many challenging cases have insufficient amount of sample material for analysis. CGI’s TOO® aids in identifying the source of such challenging tumors while using less material, and could be used as a diagnostic or confirmatory tool both for routine clinical testing and for clinical trial enrollment of patients with such tumors, enabling them to be considered for novel drug therapies.
Cautious optimism circles this healthcare player, as TipRanks analytics exhibit CGIX as a Buy. Out of 3 analysts polled in the last 12 months, 2 are bullish on Cancer Genetics’ stock, while 1 remains sidelined.