Tissue of Origin Test Results May Have Treatment Implications

A new gene expression test, called the Tissue of Origin (TOO) test, designed to analyze a tumor’s genomic information, received 510(k) clearance from the Food and Drug Administration (FDA)

The TOO test, developed by Cancer Genetics, Inc., assesses 2,000 individual genes that are found within about 90 percent of all solid tumors, including thyroid, breast, lung, pancreatic, gastric, colorectal, liver, bladder, kidney, ovarian, testicular and prostate cancers, as well as non-Hodgkin lymphoma, melanoma and sarcoma. The test then uses this information to identify a tumor’s origin, which can help to classify it as metastatic, poorly differentiated or undifferentiated.

“This 510(k) clearance represents an important milestone toward our goal of gaining broad adoption of the test,” John A. (Jay) Roberts, interim chief executive officer and chief operations officer of Cancer Genetics, said in a press release.

Currently, TOO is Medicare-reimbursed, and, according to the release, is the only FDA-cleared test of its kind. Tests like these are growing increasingly important, as TOO results lead to treatment changes about 65 percent of the time and a site treatment change about 35 percent of the time, according to Cancer Genetics.

“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 US and Europe each year. This includes the subset of patients with cancer 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,” Rita Shaknovich, chief medical officer of CGI, said.

The most recent version of TOO has some differences from an earlier version. The test has new labeling reagents and a higher accuracy rate and shorter workflow. But this did not compromise precision and reproducibility. These new features can continue to help health care teams make more informed treatment decisions.

“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,” Roberts said.

Under this clearance, also known as Premarket Approval (PMA), a manufacturer must demonstrate to the FDA that it is substantially equivalent (as safe and effective) to a device already on the market. This occurs within 90 days before the company plans to put the device on the market. In the meantime, the FDA rules whether there is currently another similar or identical device that is already in use, which determines whether the company can manufacture the device.