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Thomas Jefferson University Hospital Offering Roche's FDA-Approved BRAF Test

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Thomas Jefferson University Hospital this week said it will offer Roche's Cobas 4800 BRAF V600 Mutation Test.

The hospital claimed that it is the first academic medical center in the US to provide the test, which was approved by the US Food and Drug Administration in August for use in determining which melanoma patients may benefit from treatment with Roche/Plexxikon's drug Zelboraf.

“Jefferson’s clinical laboratories have officially begun utilizing the FDA-approved test to help determine melanoma patients’ status and a subsequent and immediate treatment plan,” the hospital said in a statement. “According to Roche Diagnostics, its tool has improved sensitivity, accuracy, and speed compared to other commonly used detection methods.”

Roche recently released data showing that its PCR-based BRAF test is more sensitive than Sanger sequencing in selecting which patients will benefit from Zelboraf. The company released this data in an effort to convince more labs to replace their standard laboratory-based testing methods with its FDA-approved companion diagnostic (PGx Reporter 9/28/2011).

Although Roche's test is the only FDA-approved assay for gauging BRAF mutations in melanoma patients considering treatment with Zelboraf, CLIA-certified laboratories can legally market LDTs for gauging BRAF mutations as long as the FDA continues to exercise “enforcement discretion” over lab-developed tests.

While academic medical centers may therefore choose to stick with their LDTs rather than adopt the more expensive FDA-approved test, Thomas Jefferson University Hospital asserted that Roche's BRAF test would benefit patients.

“Melanoma is a deadly skin cancer, and this FDA-approved diagnostic tool plays a pivotal role in our approach to it,” Stephen Peiper, chair of the university's pathology, anatomy, and cell biology department, said in a statement. “The BRAF mutation test will allow us to quickly and accurately identify patients here at the hospital who will respond positively to this new treatment.”

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