Industry Newsmaker: Veracyte, Inc. Scores Big with Percepta and Affirma GEC

Veracyte, Inc. is a leader in developing noninvasive genomic diagnostic tests for lung cancer. And in February, Veracyte’s share of this lucrative market grew significantly.

Percepta Gets Thumbs Up from Medicare
It started on Feb. 6 when Veracyte announced that Medicare Administrative Contractor Palmetto GBA had issued a local coverage determination making the firm’s Percepta Bronchial Genomic Classifier the first genomic test covered by Medicare for improved lung cancer screening and diagnosis.

The US market for Percepta is $425 million to $525 million, according to company estimates. Approximately 50 percent of that market is comprised of Medicare patients.

Affirma GEC for Quest
But the month was just starting. The very next day, Veracyte had more good news regarding another one of its products, Affirma Gene Expression Classifier (GEC), a lab-developed test that uses fine needle aspiration biopsies to evaluate thyroid nodules for cancer, eliminating the need for surgery. On Feb. 7, Veracyte announced that it had made a deal with lab giant Quest Diagnostics allowing Quest’s physician clients to order Affirma GEC for its patients and refer specimens to Veracyte for genomic testing. Quest will make the service available via its AmeriPath anatomic pathology business of Quest Diagnostics, for use on cytopathology results of biopsies that are indeterminate, i.e., not clearly benign or malignant.

Affirma GEC Gets Blue Cross Blue Shield Coverage
It would get even better for Veracyte. Two weeks after the Quest deal was announced, Veracyte reported that 10 separate Blue Cross Blue Shield plans had issued positive coverage decisions finding Affirma medically necessary for diagnosing thyroid cancer. Word of the BCBS decision, which could be worth $26.4 million in additional revenue to Veracyte, fueled a 1 percent increase in the company’s shares in the next morning’s Nasdaq trading.

For more on Veracyte, see LIR, June 6, 2016.


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