Veracyte, Inc. today announced that new data presented at ENDO 2018, the annual meeting of the Endocrine Society, suggest that the Afirma Genomic Sequencing Classifier (GSC) can help significantly more patients avoid unnecessary surgery in thyroid cancer diagnosis, compared to the original Afirma test. The findings were presented in a poster session during the conference, being held March 17-20 in Chicago.
“Our study is the first to assess how the Afirma GSC performs in real-world clinical practice,” said Michael H. Shanik, M.D., an endocrinologist with Endocrine Associates of Long Island, who presented the new findings. “We found that the enhanced genomic test identified nearly two thirds of patients as benign – which is even more than was reported in our clinical validation study and reflects a significant increase compared to the original Afirma test.”
In the new study of 5,478 consecutive samples evaluated with the Afirma GSC following indeterminate cytopathology results, researchers found that the Afirma GSC identified 64 percent as benign and 36 percent as suspicious for cancer. In comparison, they found that the original Afirma test identified 44 percent of patients as benign following indeterminate cytopathology. Because of the Afirma classifier’s previously demonstrated high negative predictive value (95 percent), patients with benign genomic testing results are typically monitored with imaging in lieu of undergoing diagnostic surgery.
“Our original Afirma test has already transformed thyroid cancer diagnosis, where we estimate it has helped tens of thousands of patients avoid unnecessary surgery and saved significant healthcare costs,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “The Afirma GSC builds on that success, combining deep RNA sequencing and machine learning to provide a more granular genomic assessment of thyroid nodules. As a result, the Afirma GSC can better distinguish between even challenging thyroid biologies, such as Hurthle cells, and keep even more patients safely out of the operating room.”
The Afirma Genomic Sequencing Classifier combines RNA sequencing data with machine learning to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to preserve the thyroid. Since the commercial introduction of Afirma in 2011, Veracyte has performed over 100,000 genomic tests, and estimates it has saved more than 40,000 patients from unnecessary thyroid surgery and removed an estimated $800 million in surgery costs from the healthcare system. The Afirma classifier is included in most leading clinical guidelines and is covered as medically necessary by Medicare and all of the major U.S. health plans. The company plans to introduce the Afirma Xpression Atlas platform soon, which will use RNA sequencing to extract extensive genomic data – including gene expression, variants and fusions – from thyroid cytology samples.
Veracyte, Inc. (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).
Source – BusinessWire