SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--During National Thyroid Awareness Month in January, Veracyte, Inc. (NASDAQ: VCYT) announced that to date it has performed 100,000 Afirma genomic tests to help reduce unnecessary surgeries in patients being evaluated for potential thyroid cancer. Veracyte also announced that since its Afirma solution became available in 2011, the company has touched over 325,000 patients with Afirma and helped more than 40,000 patients avoid having all or part of their thyroids removed unnecessarily.
“This is a significant milestone and we’re proud to be leading in a new era of genomic medicine in which our Afirma classifier is giving physicians and patients better diagnostic answers,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “With the advances that we have made in combining deep RNA sequencing and machine learning, we are committed to helping more patients avoid unnecessary surgery, while informing surgical decision-making on those who are likely to have thyroid cancer.”
Data suggest that the Afirma Genomic Sequencing Classifier (GSC) can save nearly 70 percent of patients with benign thyroid nodules from unnecessary surgery by identifying their nodules as benign following indeterminate results on their fine needle aspiration (FNA) biopsies. The enhanced Afirma GSC, which identifies 30 percent more benign cases than the original Afirma test, was introduced in May 2017.
“Thyroid cancer diagnosis is a poster child for overtreatment in medicine,” said Dr. Kepal N. Patel, Chief, Division of Endocrine Surgery, NYU Langone Medical Center. “Distinguishing benign from cancerous thyroid nodules has historically been challenging for physicians when traditional testing results are inconclusive. Unfortunately, patients have often paid a high price for this diagnostic uncertainty, with many patients undergoing surgery just to find out they didn’t have cancer.”
All patients who undergo full removal of the thyroid (thyroidectomy) and nearly one in five patients who undergo a partial thyroidectomy experience a loss of thyroid function (hypothyroidism), which requires lifelong daily thyroid hormone replacement medication. Patients with hypothyroidism can develop weight gain, fatigue, sleepiness and other symptoms – conditions that can be difficult to regulate even with medication.
Each year in the United States, more than 525,000 fine needle aspiration biopsies are performed to assess patients with potentially cancerous thyroid nodules. Up to 30 percent of the results are indeterminate (not clearly benign or malignant) and physicians have traditionally recommended thyroid surgery for a more definitive diagnosis. Following surgery, however, 70 to 80 percent of patients' nodules are diagnosed as benign, meaning the surgery was unnecessary. Such surgery is invasive, costly and often leads to the need for lifelong daily thyroid hormone replacement drugs. The Afirma classifier is included in most leading medical guidelines and is covered as medically necessary by Medicare and all of the major U.S. insurance companies.
About Veracyte
Veracyte (NASDAQ: VCYT) is a leading genomic diagnostics company that is providing trustworthy and actionable answers that fundamentally improve patient care when current diagnostic tests are uncertain. The company's products uniquely combine genomic technology, clinical science and machine learning to provide answers that give physicians and patients a clear path forward without risky, costly surgery that is often unnecessary. Since its founding in 2008, Veracyte has commercialized three genomic tests, which are transforming the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis and collectively target a $2 billion market opportunity. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, our belief that the use of the Envisia classifier to enable diagnosis of idiopathic pulmonary fibrosis, without the need for invasive, risky and costly surgical procedure; Envisia's ability to further give physicians confidence in using our test in lieu of surgery; and Envisia's ability to significantly improve patient care and reduce healthcare costs. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: benefits of our tests, the applicability of clinical results to actual outcomes; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our ability to successfully achieve and maintain adoption of and reimbursement for our products; the amount by which use of our products are able to reduce invasive procedures and misdiagnosis, and reduce healthcare costs; the occurrence and outcomes of clinical studies; and other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2017. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
Veracyte, Afirma, Percepta, Envisia, the Veracyte logo, and the Afirma logo are trademarks of Veracyte, Inc.
