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Veracyte, Inc. (NASDAQ: VCYT) will extend access to its Afirma Gene Expression Classifier (GEC) through an agreement with Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services. The agreement is intended to meet growing physician demand for innovative genomic testing services to improve thyroid cancer diagnosis.

The Afirma GEC is a laboratory-developed test that is widely ordered by physicians who perform fine needle aspiration (FNA) biopsies to evaluate thyroid nodules for potential cancer. Under the agreement, physician clients of Quest Diagnostics will be able to order the test on behalf of patients and refer patient specimens to Veracyte for genomic testing. Quest Diagnostics will make the service available through AmeriPath, the anatomic pathology business of Quest Diagnostics, for use on cytopathology results of these biopsies in cases when they are indeterminate (not clearly benign or malignant).

Veracyte currently makes the Afirma GEC available to physicians at institutions and community-practice settings throughout the country. Quest Diagnostic serves approximately half the physicians and hospitals in the United States, further broadening access to the Afirma GEC for patients who could benefit.

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

"We are pleased to partner with Quest Diagnostics to further make the Afirma GEC available to physicians and their patients as our test increasingly becomes the new standard of care in thyroid cancer diagnosis," said Bonnie Anderson, Veracyte's chairman of the board, president and chief executive officer. "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."

Since launching the genomic test in 2011, Veracyte has performed over 65,000 Afirma GEC tests and estimates that the test has helped prevent more than 25,000 unnecessary thyroid surgeries. Such surgeries are invasive, costly and because they involve removal of all or part of the thyroid often render patients dependent on lifelong daily thyroid hormone replacement drugs. The Afirma GEC is supported by more than 20 published studies, including a clinical validation study published in The New England Journal of Medicine, and is recommended in leading clinical practice guidelines. The Afirma GEC is covered by Medicare and most leading private insurance companies, which collectively represent approximately 200 million Americans.

"Indeterminate thyroid nodules pose a significant challenge to physicians and patients, and many people have undergone unnecessary surgeries because it was difficult to rule out cancer in advance. It puts the physician and the patient in a difficult position," said Christopher C. Fikry, M.D., general manager, oncology, Quest Diagnostics. "The Afirma GEC is a terrific example of how diagnostic innovation can help replace uncertainty with clarity to promote better care and outcomes. We look forward to making it available through our already significant offering in cancer and endocrinology so that fewer people face the specter of unnecessary surgery and treatment."

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. 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.

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Veracyte (VCYT) Enters Agreement with Quest Diagnostics (DGX) to Expand Patient Access to GEC - StreetInsider.com

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