Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Veracyte Receives New York State License for Afirma® Gene Expression Classifier

Published: Wednesday, September 12, 2012
Last Updated: Tuesday, September 11, 2012
Bookmark and Share
Veracyte and Genzyme also announce that Memorial Sloan-Kettering Cancer Center is among the state's first institutions to offer genomic test to patients with inconclusive thyroid nodule results.

Veracyte, Inc. and Genzyme have announced that the New York State Department of Health has issued a license enabling Veracyte's Afirma® Gene Expression Classifier to be offered to patients in the state.

The companies also announced that Memorial Sloan-Kettering Cancer Center will become one of the first medical institutions in the state to offer patients the genomic test, which helps resolve inconclusive thyroid nodule results following traditional evaluation of fine needle aspiration (FNA) samples.

"We are delighted that the Afirma Gene Expression Classifier will now be available to physicians and their patients in New York State and that Memorial Sloan-Kettering is among the first in the state to offer our test," said Bonnie Anderson, Veracyte's cofounder and chief executive officer.

Anderson continued, "These milestones underscore the clinical need for and strength of the clinical data behind our test. Our goal is to help identify patients whose thyroid nodules are actually benign so that they may avoid unnecessary, invasive surgery."

Thyroid cancer is the fastest-increasing cancer in the United States, with 56,460 new cases expected in 2012, according to the American Cancer Society.

Approximately 450,000 thyroid nodule FNAs - a minimally invasive procedure to extract cells for examination under the microscope - are performed each year in the U.S. to rule out cancer.

Up to 30% of the time, the results are inconclusive, and current protocols typically recommend thyroid surgery for final diagnosis. Following surgery, however, 70-80% of patients turn out to have benign nodules.

The Afirma Gene Expression Classifier measures the expression of 142 genes to reclassify ambiguous thyroid FNA samples as either benign or suspicious for cancer.

A clinical validation study, published recently in the New England Journal of Medicine, showed that when applied to the major categories of indeterminate thyroid samples, the test reclassified the samples as benign with greater than 94% accuracy.

The Afirma Gene Expression Classifier is offered as part of Veracyte's comprehensive Afirma Thyroid FNA Analysis, which combines specialized cytopathology assessment for initial review of thyroid nodule FNAs, with the gene expression test used to clarify inconclusive results.

The test is now covered for Medicare patients nationwide and is available throughout the U.S. through a global co-promotion partnership with Genzyme, a Sanofi company and one of the world's leading biotechnology companies.

"We look forward to bringing to New York endocrinologists and thyroid patients a complete solution, which includes the Afirma Thyroid FNA Analysis for thyroid nodule assessment and Thyrogen® for the management of patients diagnosed with thyroid cancer," said Alicia Secor, Genzyme's vice president and general manager of Endocrinology.

Genzyme is an established leader in endocrinology globally, developing and marketing Thyrogen® (thyrotropin alfa for injection) for patients with well-differentiated thyroid cancer.

Thyrogen® is used as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow up of patients with well-differentiated thyroid cancer.

Thyrogen® is also approved in the U.S. and Europe as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of metastatic thyroid cancer.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,300+ scientific posters on ePosters
  • More than 4,900+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Veracyte to Acquire Allegro Diagnostics
Plans to launch lung cancer test in the second half of 2015, with meaningful revenue expected in 2017.
Tuesday, September 09, 2014
Scientific News
Detecting Alzheimer's with Smell Test
Odour identification test may offer low-cost alternative for predicting cognitive decline and detecting early-stage Alzheimer’s disease.
CDC Updates Zika Recommendations
CDC has issued updated Zika recommendations and guidance for healthcare providers with a focus on sexual transmission.
Review of the Analysis of Haemoglobin A1c for Diabetes Diagnostics
This paper aims to clarify methods, units, quality requirements, reference and cutoff limits for hemoglobin A1c (HbA1c) and ratio of blood glucose/HbA1c on the basis of the results from Finnish quality control surveys by comparing them to the literature.
Colon Cancer Blocked in Mice
Case Western Reserve University Researchers block common type of colon cancer tumour in mice, laying groundwork for human clinical trial.
Drug - Gene 'One-Two' Punch Against Cancer
Researchers identify gene-drug combinations that, together, target and kill cancer cells while not targeting healthy cells.
Liquid Biopsies Treating Ovarian Cancer
Researchers have discovered a promising monitor and treat recurrence of ovarian cancer. Detecting cancer long before tumours reappear.
72% Rise in Metastatic Prostate Cancer
Over the 2003-2013 period metastatic cancer has increased by an average of 72%, this could be caused by lax screening, more aggressive disease or both.
Lab-Tested Diagnosis Needed When Treating Persistent Diarrhea
New PCR multiplex method makes lab testing more effective.
Biomarker for Multiple Sclerosis Detection Discovered
Winthrop-University Hospital researchers discover biomarker for multiple sclerosis detection.
Scientists Link Bipolar Disorder to Unexpected Brain Region
Researchers from The Scripps Research Institute have found that gene within the brain’s striatum could be linked to biopolar disorder.
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!