Veracyte, Inc, a diagnostics company pioneering the field of molecular cytology to improve patient outcomes and lower healthcare costs, and Fleury Medicine and Health announced a new partnership that will make Veracyte's Afirma Gene Expression Classifier (GEC) available to patients in Brazil, helping to reduce unnecessary surgeries and potentially lower costs there as part of thyroid cancer diagnosis. Financial terms of the agreement were not disclosed.
Through the agreement, Fleury, which has diagnostics centers across Brazil, will exclusively offer the Afirma GEC when patients' thyroid nodule fine needle aspiration (FNA) results are indeterminate – not clearly benign or malignant – following cytopathology review. Genzyme, Veracyte's global co-promotion partner, will promote the Afirma GEC to physicians throughout Brazil, who will order the test through Fleury. FNA samples for the Afirma GEC will be sent to Veracyte's CLIA-certified laboratory in South San Francisco, Calif., for analysis.
"We are pleased that physicians and patients in Brazil will now be able to benefit from the Afirma Gene Expression Classifier, which has already helped spare thousands of patients in the United States from unnecessary thyroid surgeries since its commercial launch here in 2011," said Bonnie H. Anderson, president and chief executive officer of Veracyte. "Fleury is one of the largest and most respected diagnostics centers in Brazil and currently offers FNA cytopathology testing to patients across the country, making it an ideal partner to direct indeterminate thyroid nodule cases to the Afirma GEC."
Veracyte's genomic test is used to identify patients whose thyroid nodules are benign following an indeterminate cytopathology result and who can thus potentially avoid unnecessary diagnostic surgery. Based on 2014 Brazilian National Cancer Institute (INCA) estimates of 9,050 newly diagnosed thyroid cancers per year, Veracyte and Fleury estimate that nearly 100,000 thyroid nodule FNAs are performed each year on patients in Brazil, with 15% to 30% of such FNAs assumed to be inconclusive. Traditionally, these patients have been directed to surgery, with most of such thyroid nodules ultimately proving to be benign.
"Traditional techniques for evaluating thyroid nodules are limited, leading many patients to undergo surgery to remove all or part of their thyroids just to get a diagnostic result. These surgeries are invasive, costly and often result in lifelong thyroid hormone replacement therapy for the patient," said Dr. Rosa Paula Mello Biscolla, specialist in endocrinology at Fleury Medicine and Health. "Use of the Afirma GEC will enable physicians to help many patients avoid a surgery they do not need. This will improve patient care and should help reduce healthcare costs."
The Afirma GEC's clinical utility and cost-effectiveness have been demonstrated in multiple, peer-reviewed, published studies and its performance was established in a clinical validation study published in the New England Journal of Medicine in 2012. It is the only molecular test with published validation data demonstrating that it meets the performance criteria established in National Comprehensive Cancer Network (NCCN) guidelines for safely monitoring thyroid nodules in lieu of diagnostic surgery.
Fleury Medicine and Health is a national benchmark in diagnostic medicine and it offers over 3,000 different tests in 37 different medical specialties. The brand is also a precursor in the concept of integrated medical center that offers a complete diagnostic solution, medical advice and differentiated services.