LabCorp Develops Companion Diagnostic for Roche Cancer Drug

LabCorp has introduced a new companion diagnostic intended to aid patients in their treatment of non-small cell lung cancer (NSCLC).

The test, called cobas®, is to be used in conjunction with the Roche-manufactured drug Tarceva. That drug is used specifically to treat patients who have an initial diagnosis of NSCLC that has metastasized into other parts of the body. It can be useful for treating patients whose cancer has certain epidermal growth factor receptor (EGFR) mutations.

The LabCorp test focuses specifically on whether patients have a deleted exon 19 or exon 21 in the EGFR in their tumors, which is an indicator that Tarceva would be effective. The assay can be performed either using blood or tumor tissue. It is particularly useful for patients who are unable to undergo a tissue biopsy. Tarceva sales totaled nearly $1.2 billion last year.

“The FDA approval of the ... test ... offers a minimally invasive option for patients with NSCLC,” said Uwe Oberlaender, who heads Roche’s molecular diagnostics division. “Partnering with key labs ensures that patients can be tested conveniently.”

NSCLC lung cancer is among the deadliest forms of the disease, with long-term survival rates for patients with metastasis around 1 percent. The five-year survival rate for the disease is much higher if the tumor is localized, but symptoms often do not present until the cancer is advanced.

The North Carolina-based LabCorp said it received approval for the test from the U.S. Food and Drug Administration on June 1 and that it was the first test of its kind being offered in the country. A company spokesperson declined to release the retail price for the assay, which is available through LabCorp directly and via its Integrated Oncology affiliate.

“LabCorp is pleased to add this important new test to our menu of world-class diagnostics,” said Marcia Eisenberg, LabCorp’s chief scientific officer. “Knowledge is power for patients and their physicians, and tests like this can help patients access targeted, personalized treatment.”

Takeaway: LabCorp is offering a companion diagnostic to one of the leading drugs for treating NSCLC lung cancer