Medicare Covers the Pathwork® Tissue of Origin Test

Helps Diagnose Metastatic and Other Difficult to Diagnose Cancers

Redwood City, CA, June 13, 2011 – Pathwork Diagnostics, Inc., a molecular diagnostics company focused on oncology, announced today that Palmetto GBA, the contractor that administers Medicare in California, has issued a positive coverage policy for the Pathwork® Tissue of Origin Test. Because all Tissue of Origin test specimens are processed in the Pathwork Diagnostics Laboratory in California, the Palmetto decision means that the test will be covered for Medicare patients across the nation. The Tissue of Origin Test helps identify the primary tumor in difficult to diagnose cancer cases such as those that are metastatic or with a complex clinical history.

“Cancers are best treated according to their respective sites of origin and tissue type,” explained Karo K. Arzoo, M.D., Oncologist at the Roy and Patricia Disney Family Cancer Center and Chair of Hematology and Oncology at Providence Saint Joseph Medical Center in Burbank, CA, and Clinical Instructor at University of Southern California Norris Comprehensive Cancer Center in Los Angeles, CA. “This is true even when the disease is metastatic (spread to other locations in the body) at the time of diagnosis.” An accurate diagnosis of the primary tumor site helps the physician choose the best course of treatment for the patient.

“I think making the diagnosis was the difference between life and death,” cancer survivor Lance Shackelford remembered. “Now I had a chance of recovery.” Initial pathology results suggested that rapidly growing tumors in Lance’s chest were a rare and aggressive form of cancer which is difficult to diagnose and treat. However, the Pathwork Tissue of Origin Test strongly indicated testicular germ cell cancer. This was good news for Lance because testicular germ cell cancer is much more treatable.

In the case of retired schoolteacher Stella Carroll, standard pathology tests on a swelling in her armpit suggested cancer that could have originated in the ovary, cervix, esophagus, head or neck, while an MRI showed suspicious lesions in her breast and chest wall suggestive of breast cancer. Results of the Tissue of Origin Test indicated breast cancer with high confidence and ruled out 14 other cancer types.

“In the back of my mind, I thought I was going to die until they found out what was wrong,” Stella said. “When the Tissue of Origin Test also showed a result of breast cancer, that relieved me tremendously to know we could get started with the treatment.”

The Pathwork Tissue of Origin Test is the only FDA-cleared molecular diagnostic test for tissue of origin. The test has been extensively evaluated in multiple independent studies involving more than 1,100 patient specimens, including large validation studies published in the Journal of Clinical Oncology and the Journal of Molecular Diagnostics. To have a specimen processed by the Pathwork Diagnostics Laboratory using the Tissue of Origin Test or to learn more, call Pathwork Diagnostics at (877) 808-0006 or visit www.pathworkdx.com.

About Pathwork Diagnostics
Pathwork Diagnostics, Inc. is a privately held company based in Redwood City, CA, that develops and commercializes high-value molecular diagnostics for oncology. For more information call toll-free (877) 808-0006 or visit www.pathworkdx.com.