Medicare Now Covers Tissue of Origin Test

Palmetto GBA, Medicare administrator for California, will now allow coverage for the Pathwork Diagnostics Tissue of Origin Test. Because all tissue of origin tests are processed in the Pathwork Diagnostics Laboratory in California, the Palmetto decision means that the test will be covered for patients nationwide.

The tissue of origin test is used to identify the primary tumor in metastatic disease, or those with a complex clinical history, through gene expression. A tumor’s site of origin may be difficult to determine because the original tumor may be small, and thereby avoid detection by imaging and other techniques. Tumor cells also may change appearance and no longer resemble tumors from the originating site.

Knowing the primary tissue type with greater certainty helps physicians prescribe prompt treatment with the most appropriate regimens. According to Pathwork Diagnostics’ website, “up to 10 percent are tumor types not readily classifiable in the course of the initial diagnostic workup. These tumors, which may be metastatic, undifferentiated, or poorly differentiated, are among the most frustrating for physicians, and place a disproportionate burden on patients, health care professionals, and the health care system.”

Pathwork Diagnostics’ Tissue of Origin Test by was approved by the Food and Drug Administration (FDA) in 2010, and currently is the only FDA-cleared molecular diagnostic test for tissue of origin.

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