FDA Gives Thumbs Up to Cancer Genetics' TOO Diagnostic Test

Oncologists are going to get one more tool for their arsenal to try and treat cancer, thanks to the U.S. Food and Drug Administration green-lighting the Tissue of Origin, or TOO®, test of Cancer Genetics Inc. (NASDAQ:CGIX).

The Rutherford, New Jersey based precision medicine company said that the FDA gave 510(k) clearance for the microarray gene expression test subsequent to modifications being made to test reagents and software.

By analyzing genomic information from the tumor TOO can help identify the tumor's origin, a value add in classifying metastatic, poorly differentiated, or undifferentiated cancers. Every year in the U.S. and Europe, about 150,000 cases of metastatic cancer are diagnosed without proper identification of where the cancer started.

The test can assess 2,000 individual genes, spanning 15 of the most common types of tumors and 90% of all solid tumors, including, but not limited to, breast, non-small cell lung, pancreatic, ovarian, melanoma, prostate and non-Hodgkin's lymphoma.

The company trumpets that there is no other test like it available today and it is the only one that provides a pathologist's review and interpretation of the results. Research shows that TOO can lend further credence and specificity to widely used diagnostics such as immunohistochemistry.

Furthermore, Medicare reimburses for TOO.

"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," commented John A. (Jay) Roberts, Interim CEO and COO of Cancer Genetics, in a statement today.

The good news comes to a company in turmoil at the moment. Cancer Genetics has the whole truckload of usual ambulance-chasing lawyers seeking a shareholder lawsuit making boilerplate allegations of mismanagement and misleading shareholders as they troll for a lead plaintiff.

The catalysts were the resignation of Panna Sharma as President, CEO and a director in February followed by the announcements of recording bad debt, a (not-out-of-the-ordinary) "going concern" statement and a strategic review to determine the best course for the company.

After being brutalized by the corporate announcements and lawyers spamming the news feed, shares of CGIX are amongst the top performers for NASDAQ issues on Monday, rising 44.4% to $1.40 as 1:00 p.m. approached in New York.