Navigation Links
Veracyte Announces Medicare Coverage for Its Afirma® Gene Expression Classifier for Improved Thyroid Nodule Diagnosis
Date:1/9/2012

SOUTH SAN FRANCISCO, Calif., Jan. 9, 2012 /PRNewswire/ -- Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, today announced that Palmetto GBA, a national contractor that administers Medicare benefits, has established coverage for the company's Afirma Gene Expression Classifier for use in thyroid nodule diagnosis. This means that Veracyte's genomic test is now accessible to 40 million Medicare patients nationwide. Clinical data has shown that Veracyte's test helps resolve inconclusive results on thyroid nodule fine needle aspiration (FNA) samples being tested for cancer with a high degree of accuracy, demonstrating potential to help tens of thousands of patients each year avoid surgery.

Thyroid cancer is the fastest-growing cancer in the United States, with an estimated 48,020 new cases expected in 2011, according to the American Cancer Society. Approximately 450,000 thyroid nodule FNAs – a minimally invasive alternative to surgical biopsy – are performed each year in the U.S. In up to 30 percent of cases, the results are ambiguous, with current guidelines recommending surgery for most of these patients to obtain an accurate diagnosis. This approach is invasive, costly and can result in lifetime hormone therapy for the patients. Inconclusive thyroid FNA results, however, carry only a 20-30 percent chance of malignancy.

"We are pleased by this coverage decision," said Bonnie Anderson, cofounder and chief executive officer of Veracyte. "Inconclusive results on thyroid nodule FNA samples are a common and significant problem for patients and their physicians. This decision will help Medicare patients with inconclusive results access our Afirma Gene Expression Classifier, enabling them to potentially avoid surgery, while also saving money for the Medicare program."

With the move, Veracyte's Afirma Gene Expression Classifier also becomes one of the first molecular diagnostics tests to be granted Medicare coverage under Palmetto GBA's new Laboratory and Molecular Diagnostics Services Program. The initiative requires companies seeking Medicare coverage for such tests to register them and submit evidence of their clinical utility and effectiveness.

"Palmetto GBA's coverage of the Afirma Gene Expression Classifier demonstrates our commitment to ensuring that the molecular diagnostics tests we cover provide a proven clinical benefit to Medicare patients," said Elaine Jeter, M.D., medical director of Palmetto GBA. "We also believe that a more consistent and transparent approach to reimbursement will help to further drive innovation in the rapidly growing molecular diagnostics field."

Veracyte's gene expression test has been shown in two independent studies – both part of a large, multicenter, prospective clinical trial involving academic and community sites – to be able to reclassify patients with indeterminate thyroid FNA results as "benign" with the same degree of accuracy as a benign diagnosis by cytopathology. Additionally, researchers from the Johns Hopkins University School of Medicine concluded recently that routine use of the Afirma Gene Expression Classifier on patients with indeterminate thyroid nodule FNA results would prevent tens of thousands of unnecessary surgeries each year and would provide more than $600 million in direct medical savings over five years in the U.S. Their findings were published recently in the Journal of Clinical Endocrinology & Metabolism.

Veracyte began commercializing its genomic test in late 2010 as part of its comprehensive Afirma Thyroid FNA Analysis offering. This comprehensive approach to thyroid nodule diagnosis combines expert cytopathology assessment by Veracyte's partner, Thyroid Cytopathology Partners, with the company's Afirma Gene Expression Classifier used to clarify inconclusive thyroid FNA results as benign or suspicious for cancer.

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 disease 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, multicenter clinical program throughout discovery and development. Veracyte's first product – the Afirma Thyroid FNA Analysis – combines expert cytopathology assessment with the Afirma Gene Expression Classifier, a genomic test that clarifies inconclusive thyroid nodule results as benign or suspicious for cancer. The company is currently in the early biomarker discovery phase for lung cancer and interstitial lung diseases. 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. New Data Suggest Veracytes Molecular Test Improves Accuracy of Thyroid Nodule Diagnosis Using Fine Needle Aspirate (FNA) Samples
2. New Data Suggest Veracytes Afirma® Gene Expression Classifier Cost-Effectively Resolves Inconclusive Thyroid Nodule FNA Biopsy Results
3. China-Biotics, Inc. Announces Conference Call to Discuss First Quarter 2009 Financial Results
4. Odyssey Thera Announces Milestone Achievement in Pfizer Alliance
5. InNexus Biotechnology Announces Launch of Large Scale Primate Study of DXL625
6. Anesiva Announces Second Quarter 2008 Financial Results and Update
7. SGX Pharmaceuticals Announces Financial Results for the Three and Six Months Ended June 30, 2008
8. Insmed Announces Financial Results for Second Quarter and Six-Months Ended June 30, 2008
9. China Sky One Medical, Inc. Announces Conference Call to Discuss Second Quarter 2008 Results
10. China Yingxia International, Inc. Announces Conference Call to Discuss Second Quarter 2008 Results
11. ThirdBiotech Announces Kemeta as Newest Sponsor
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... 2016  Neurocrine Biosciences, Inc. (NASDAQ: NBIX ) today announced ... 2015. --> --> For ... of $29.3 million, or $0.34 loss per share, compared to a ... the same period in 2014. For the year ended December 31, ... $1.05 loss per share, as compared to a net loss of ...
(Date:2/11/2016)... NEW YORK , Feb. 11, 2016  Bioethics International, ... how medicines are researched, developed, marketed and made accessible to ... BMJ Open had named the publication of the ... for 2015. The publication is also featured as one of ... published in the last year that are most frequently read. ...
(Date:2/11/2016)... ... February 11, 2016 , ... ... dedicated to delivering cutting-edge information focused on the development and manufacture of ... become a premier sponsor of the 2016 BioProcess International Awards – Recognizing ...
(Date:2/11/2016)... BioInformant announces the February 2016 release of its ... and Technologies – Market Size, Segments, Trends, and Projections ... The first and only market research firm ... more than a decade of historical information on all ... type. This powerful 175 page global strategic report contains ...
Breaking Biology Technology:
(Date:2/2/2016)... NEW YORK , Feb. 2, 2016 ... healthcare facilities are primarily focused on medical ... that measure point-of-care parameters. Wearable devices that ... a user,s freedom of movement are being ... sensors for human biomedical signal acquisition coupled ...
(Date:2/2/2016)... NEW YORK , Feb. 2, 2016 /PRNewswire/ ... Potentials of that Rising Market Are you ... new analysis forecasts revenues for checkpoint inhibitors. Visiongain,s ... world market, submarket, product and national level. ... Instead discover what progress, opportunities and revenues those ...
(Date:2/2/2016)... , Feb. 2, 2016   Parabon NanoLabs ... the U.S. Army Research Office and the Defense ... and sensitivity of the company,s Snapshot Kinship ... Mission and, more generally, defense-related DNA forensics.  Although ... capabilities (predicting appearance and ancestry from DNA evidence), ...
Breaking Biology News(10 mins):