Thyroid Nodule Testing By Molecular Cytology

Many people have thyroid problems.  Due to the instability of trying to control the function of the thyroid nodules can develop. An endocrinologist will need to do a biopsy if calcification is seen from an ultrasound
report. The doctor will take an aspiration needle and extract tissue from the nodules to be put on slide and prepared by the histology lab for the pathologist to view to determine carcinoma.

Genzyme and Veracyte have a great announcement concerning diagnosing cancer from thyroid nodules . These companies are the leaders in molecular cytology as tool for diagnosis.

The following are excerpts from a recent news article on the web about a testing product and how it really can be better than a microscopic view under a microscope.

Genzyme, a Sanofi company , and Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, today announced that the Afirma(R) Thyroid FNA Analysis, an innovative approach for improved thyroid nodule diagnosis, is now available to patients across the United States.

The Afirma(R) Thyroid FNA Analysis combines expert cytopathology assessment of thyroid nodule fine needle aspiration (FNA) samples, with the Afirma(R) Gene Expression Classifier, a novel genomic test, used to resolve inconclusive results and thus help patients whose nodules are actually benign avoid unnecessary surgery. Two independent clinical studies to date have shown that the Afirma(R) Gene Expression Classifier can reclassify patients with indeterminate thyroid FNA results as "benign" with the same degree of accuracy as a benign cytopathology diagnosis.

Thyroid cancer is the fastest-growing cancer in the U.S., with an estimated 56,460 new cases expected in 2012, according to the American Cancer Society. An estimated 450,000 thyroid nodule FNAs -- a minimally invasive procedure to extract cells for examination under a microscope -- are performed in the U.S. each year to rule out cancer. Thyroid nodule FNAs are challenging to interpret, however, producing ambiguous results in up to 30 percent of cases. Current guidelines recommend that most patients with ambiguous results undergo thyroid resection for a definitive diagnosis. Post-surgical results, however, show that only 20-30 percent of these patients have cancer. 

"Until now, most patients with 'indeterminate' thyroid nodules based on cytology went to surgery to help ensure that a cancer was not missed," said Dr. Bryan Haugen, professor of medicine and pathology at the University of Colorado School of Medicine. "Now, the Afirma(R) Gene Expression Classifier can potentially help tens of thousands of patients with inconclusive thyroid nodules each year avoid unnecessary surgery and improve patient outcomes." 

Genzyme is an established leader in endocrinology globally, developing and marketing Thyrogen(R) (thyrotropin alfa for injection) for patients with well-differentiated thyroid cancer. Thyrogen(R) is used as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging. Thyrogen(R) 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.

http://www.marketwatch.com/story/genzyme-and-veracyte-announce-expanded-us-availability-of-the-afirmar-thyroid-fna-analysis-for-improved-thyroid-nodule-diagnosis-2012-04-16?reflink=MW_news_stmp