Navigation Links
New Data Suggest Veracyte's Afirma® Gene Expression Classifier Cost-Effectively Resolves Inconclusive Thyroid Nodule FNA Biopsy Results
Date:9/1/2011

SOUTH SAN FRANCISCO, Calif., Sept. 1, 2011 /PRNewswire/ -- Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, today announced that new data from researchers at Johns Hopkins University School of Medicine suggest that routine use of its Afirma® Gene Expression Classifier for clarifying inconclusive results on thyroid nodule fine needle aspiration (FNA) samples will improve patient care and save the healthcare system money. According to the economic impact study, nationwide use of the company's test would reduce the number of surgeries on patients with benign thyroid nodules by 74%, or 50,000 each year, and would provide more than $600 million in direct medical savings over five years. The study appears online in the Journal of Clinical Endocrinology & Metabolism and is scheduled for publication in the journal's November print issue.

"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," said study author Paul W. Ladenson, M.D., professor of endocrinology and metabolism and director of the Division of Endocrinology and Metabolism at the Johns Hopkins Medical Institutions. "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."  

The study was conducted using a Markov economic model to simulate costs over five years of managing adult patients with thyroid nodules whose FNA results are deemed inconclusive by cytology. The study compared direct medical costs using current practice, which relies on cytology alone, with hypothetical use of Veracyte's Afirma Gene Expression Classifier, which classifies as benign or suspicious for malignancy those thyroid nodule FNA samples deemed indeterminate by cytology. The analysis did not include indirect costs, such as time lost at work, decreased productivity or money spent on healthcare outside of the medical setting.

In addition to reducing the number of surgeries on patients with benign nodules, the authors found that routine use of the Afirma Gene Expression Classifier on indeterminate cases increased to 54% the likelihood that patients who go to surgery will actually prove to have cancer, from 35% using current practice. There was no increase in missed cancers using the gene expression test.

"These findings add to the evidence demonstrating that our Afirma Gene Expression Classifier can enable doctors to make better and more efficient treatment decisions that improve care for thyroid patients and provide cost savings to the healthcare system," said Bonnie Anderson, Veracyte's cofounder and chief executive officer. "We look forward to continuing to make our test available to doctors and their patients across the country."

The Afirma Gene Expression Classifier is part of Veracyte's Afirma Thyroid FNA Analysis, a novel solution for improved accuracy in thyroid nodule diagnosis. This comprehensive approach combines expert cytopathology assessment along with the company's genomic test, which clarifies as either benign or suspicious for cancer those thyroid nodule FNA results initially deemed indeterminate by cytopathology. Previous multicenter studies have shown the test to have a negative predictive value of greater than 95%. Veracyte began making its solution available earlier this year to endocrinologists around the country.

Thyroid cancer is the fastest-growing cancer in the U.S., with an estimated 44,670 new cases per year. Thyroid FNAs, a procedure conducted in the doctor's office in which a needle is inserted into the suspicious nodule to extract cells for examination under a microscope, are typically used to rule out cancer. An estimated 450,000 thyroid nodule FNAs are performed in the U.S. each year, but they are challenging to interpret, producing 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. This approach is invasive, costly and can result in lifetime hormone therapy for the patients. Inconclusive results, however, carry only a 20-30% chance of malignancy.

About Veracyte

Veracyte, Inc., based in South San Francisco, Calif., is pioneering the emerging field of molecular cytology, applying molecular biomarkers to cytology samples in order to improve cancer diagnosis by clarifying indeterminate results obtained from current methods. The company aims to enable doctors to make more informed treatment decisions that improve patient care and provide cost savings to the healthcare system. The company utilizes rigorous science and an extensive, multi-center clinical program throughout discovery and development. Veracyte is privately held and funded by Domain Associates, Kleiner Perkins Caufield & Byers, TPG Biotech and Versant Ventures. For more information, visit www.veracyte.com.


'/>"/>
SOURCE Veracyte, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Swine flu breath test could reduce future vaccination shortages, research suggests
2. Pennington Biomedical Research Center Study Suggests Decreases in U. S. Occupation Energy Levels a Significant Trigger of Obesity Epidemic
3. ACO Proposed Rule: Over 90 Percent of Commercial Payer RFI Suggestions Incorporated
4. First-of-Its-Kind Study Suggests Importance of Routine Mental Health Screening in the Care of Patients Suffering From Genetic Disease PKU
5. Tarsa Therapeutics and Unigene Present Preclinical Data Suggesting Calcitonin May Have Utility in Combination Therapy for the Treatment of Osteoarthritis
6. New Data Suggest Veracytes Molecular Test Improves Accuracy of Thyroid Nodule Diagnosis Using Fine Needle Aspirate (FNA) Samples
7. Stroke Therapy with Corkscrew Device Most Beneficial, Study Suggests
8. CEL-SCI Collaborators Present Data Suggesting That LEAPS Technology Has Ability to Modify Immune Response
9. CEL-SCI Presents Data at Prestigious Medical Conference Demonstrating That Its L.E.A.P.S. Technology Stimulates Maturation of Human Blood Cells Into Dendritic Cells Suggesting Potential for Prevention and Treatment of Infectious Disease
10. New Data Suggest CIMZIA(R) (Certolizumab Pegol) Active in Treating Moderate to Severe Crohns Patients With Fistulizing Disease
11. CorMatrix Announces Pre-Clinical Data Suggesting Next Generation ECM Technology(TM) Can Improve Cardiac Function
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... CLEVELAND , June 27, 2016  Global ... average 4.6 percent through 2020 to $7.2 billion.  ... (food and beverages, cleaning products, biofuel production, animal ... and biotechnology, diagnostics, and biocatalysts). Food and beverages ... gains driven by increasing consumption of products containing ...
(Date:6/27/2016)... ... June 27, 2016 , ... Parallel 6 , the leading software as ... Clinical Reach Virtual Patient Encounter CONSULT module which enables both audio and video ... trial team. , Using the CONSULT module, patients and physicians can schedule a face ...
(Date:6/27/2016)... --  Ginkgo Bioworks , a leading organism design ... awarded as one of the World Economic Forum,s ... innovative companies. Ginkgo Bioworks is engineering biology to ... in the nutrition, health and consumer goods sectors. ... including Fortune 500 companies to design microbes for ...
(Date:6/24/2016)... ... June 24, 2016 , ... Researchers at the Universita Politecnica delle Marche in ... peritoneal or pleural mesothelioma. Their findings are the subject of a new article on ... biomarkers are signposts in the blood, lung fluid or tissue of mesothelioma patients that ...
Breaking Biology Technology:
(Date:4/28/2016)... SAN FRANCISCO and BANGALORE, India ... part of EdgeVerve Systems, a product subsidiary of Infosys (NYSE: ... service provider, today announced a global partnership that ... convenient way to use mobile banking and payment services. ... Mobility is a key innovation area for financial services, but ...
(Date:4/19/2016)... April 20, 2016 The new ... a compact web-based "all-in-one" system solution for all door ... reader or the door interface with integration authorization management ... control systems. The minimal dimensions of the access control ... the building installations offer considerable freedom of design with ...
(Date:4/13/2016)... physicians supporting Medicaid patients in Central Florida ... telehealth thanks to a new partnership with higi.   ... can routinely track key health measurements, such as blood ... they opt in, share them with IMPOWER clinicians through ... location at no cost. By leveraging this data, IMPOWER ...
Breaking Biology News(10 mins):