Overall, a series of trials evaluating the Afirma Thyroid FNA Analysis have shown that in more than 95% of the cases, when the test indicated that cancer was not present, there was in fact no cancer present.
The test underwent two independent validation studies in 2010, and many of the investigators involved in the clinical validation study are currently offering the test to patients. A larger, prospective, multi-center study is underway to further evaluate the test data, and those results are expected to be published in late 2011 or early 2012.
Data from researchers at Johns Hopkins University School of Medicine also suggest that routine use of the Afirma process nationally would reduce the number of surgeries on patients with benign thyroid nodules by 74 percent -- or 50,000 each year -- and would generate in excess of $600 million in direct medical savings over a five-year period.
Paul Ladenson, MD is professor of endocrinology and metabolism and director of the Division of Endocrinology and Metabolism at the Johns Hopkins Medical Institutions, and was one of the researchers involved in the cost analysis of the Afirma Thyroid FNA Analysis. According to Dr. Ladenson:
The clinical and economic impacts of implementing this new technology are, in fact, similar in magnitude to those that accompanied the introduction almost 40 years ago of FNA cytology to differentiate between benign and malignant thyroid nodules. We found that, even when we assessed a wide range of possible scenarios in our economic model, 93% of our projections using the gene expression test actually reduced costs while improving health outcomes. This is a rare finding for implementation of a novel management strategy.According to Richard Lanman, MD, Veracyte's Chief Medical Officer:
"The Afirma Gene Expression Classifier is intended to help rule out cancer in those indeterminate FNA samples that are truly benign. Results are classified as either benign or suspicious for malignancy. Studies to date have shown the Afirma Gene Expression Classifier's false-negative rate to be about 5%, which is in line with the false-negative rate of benign cytopathology. Today, most patients with an indeterminate cytopathology result go to surgery, but only 30% are malignant. The Afirma Gene Expression Classifier does not make a malignant call. Rather, it is optimized to identify benign FNA samples among those classified as indeterminate by cytopathology. In doing so, data show the test can reduce by half the two-thirds rate of false positives associated with current practice."In addition to reducing the number of surgeries on patients who have benign nodules, research reported on in the Journal of Clinical Endocrinology and Metabolism also found that routine use of the Afirma process could increase by more than 50% the likelihood that patients who have surgery actually do have thyroid cancer.
Bryan Haugen, MD, who was leading clinical trials of the Afirma Thyroid FNA Analysis, told the 14th International Thyroid Congress in September, 2010: "A test with this high of a negative predictive value will help doctors rule out malignancy and confidently monitor many patients with ambiguous thyroid nodules, enabling these patients to avoid unnecessary surgery."
What You Need to Know As a PatientBecause the Afirma Thyroid FNA Analysis is new, many endocrinologists and physicians are not offering it at present. So if you are going to undergo an FNA biopsy and want the Afirma Thyroid FNA Analysis used, you need to have the FNA performed by a physician who is already using the test. Patients can call Veracyte for information on physicians who offer the service.
You can also speak with your physician about offering the Afirma process. According to Veracyte, physicians and their staff can be trained in one day to adopt the Afirma FNA Thyroid Analysis process.
If you have already had an FNA biopsy that found an indeterminate nodule, and your physician is recommending thyroidectomy, you may be interested in having another FNA done with a physician who uses the Afirma Thyroid FNA Analysis process. Having a conclusive result could potentially prevent an unnecessary surgery.
The Afirma Thyroid FNA Analysis test process is priced at around $3,500.
Veracyte is currently accepting all insurance to pay for the test, and they will manage the claims process for patients. To date, several insurance companies are already reimbursing for the test. Veracyte has also set up a program called "Afirma Access," which helps patients manage out-of-pocket expense in cases where the insurance carrier may not agree to coverage.
For more information, see the Veracyte website for Afirma at http://www.veracyte.com/afirma.