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Quest Diagnostics, Veracyte Ink Agreement to Expand Access to Gene Expression Classifier

NEW YORK (GenomeWeb) – Veracyte said today that it has signed an agreement with Quest Diagnostics that will broaden access to the Afirma Gene Expression Classifier (GEC), a laboratory-developed test used to resolve indeterminate results on fine-needle-aspiration biopsies that were initially evaluated by cytopathology for potential thyroid cancer.

Physicians at institutions and community practices throughout the US already have access to the Veracyte Afirma GEC. Because Quest serves approximately half of the physicians and hospitals in the US, the agreement may help Veracyte fulfill the goal of meeting growing demand for genomic testing services that improve thyroid cancer diagnosis, the firm said.

Under the terms of the agreement, Quest will make the test service available through its anatomic pathology business AmeriPath, for use on cytopathology-based biopsy results when they are not clearly benign or malignant. Quest's physician clients will order the test and refer patient specimens to Veracyte for genomic testing.

Quest is expected to begin offering the test to its US customers in the second quarter of 2017. Financial and other terms of the agreement were not disclosed.

"We believe Quest's leadership in innovation and quality and its extensive reach to endocrinologists and other physicians will enable us to further accelerate growth for the Afirma GEC," Veracyte President and CEO Bonnie Anderson said in a statement.

Since launching Afirma in 2011, Veracyte has performed over 65,000 tests, and the firm estimates that it has helped prevent more than 25,000 unnecessary thyroid surgeries. The Afirma GEC is covered by Medicare and most leading private insurance companies, which collectively represent approximately 200 million Americans.

About 15 to 30 percent of the more than 520,000 patients who undergo evaluation for potentially cancerous thyroid nodules in the United States each year receive an indeterminate result, Veracyte said. Historically, most of these patients were directed to thyroid surgery for a definitive diagnosis. Following surgery, however, 70 to 80 percent of cases proved to be benign, meaning the surgery was unnecessary, the firm added.

Veracyte’s test helps replace uncertainty with clarity “so that fewer people face the specter of unnecessary surgery and treatment," added Christopher Fikry, general manager of oncology at Quest.

In a note to investors today, Leerink analyst Puneet Souda wrote that the test is addressing a $500 million market in the US, and that Veracyte believes that an additional $300 million market exists internationally, bringing “the total Afirma opportunity to $800 million.”