New data from Johns Hopkins University School of Medicine researchers suggest that routine use of Veracyte's Afirma gene expression classifier for clarifying inconclusive results on thyroid nodule fine needle aspiration (FNA) samples will improve patient care while saving the healthcare system money. The South San Francisco-based company is developing diagnostics for thyroid nodules and lung cancer, two disease states that have high rates of ambiguous diagnostic test results.
Thyroid cancer is the fastest-growing cancer in the U.S., with an estimated 44,670 new cases annually, the company says in a release. Thyroid FNAs, a procedure in which a needle is inserted into the suspicious nodule to extract cells for examination under a microscope, are used to rule out cancer. An estimated 450,000 thyroid nodule FNAs are performed in the U.S. each year, but they produce inconclusive results in up to 30% of cases. Current guidelines recommend that most patients with inconclusive thyroid FNAs go to surgery to remove all or part of their thyroid--an invasive and costly approach. Furthermore, inconclusive results carry only a 20% to 30% chance of malignancy.
The JHU researchers' data contained in an economic impact study show the Afirma test could reduce the number of surgeries in those with benign thyroid nodules by 74%, or 50,000 each year, and would provide more than $600 million in direct medical savings over 5 years. The study appears online in the Journal of Clinical Endocrinology & Metabolism and is scheduled for publication in the journal's November print issue.
Veracyte co-founder and CEO Bonnie Anderson told FierceMedicalDevices the company has customers in 15 states and is bringing on new accounts constantly. Veracyte is concentrating on the U.S. at this time, but might look elsewhere at some point in the future.
Over the next 18-24 months, the company will focus on accelerating the growth of its thyroid business, building its commercial team and gaining coverage from top payers, she added.
- see the Veracyte release