Interpace Diagnostics Group, a company that provides specialized molecular diagnostic tests and pathology services for evaluating risk of cancer, completed the validation and launch of two new thyroid services.
The company expects the new service offerings will generate an estimated 400 new specimens in the first 45 days following the initial launch.
"We continue to expand our product offerings to service the needs of our customers and their patients, and these service enhancements to our thyroid program are in response to what the market is telling us is important," commented Jack Stover, President and CEO of Interpace.
Interpace's new cytopathology service is designed to assist physicians and clinics that prefer to have the initial Fine Needle Aspirate (FNA) biopsy assessed by an independent third party versus having it performed on site.
The cytopathology service will be provided by a network of three of the top pathology labs in the country for assessing thyroid cancer risk, including Allegheny General Hospital, Pittsburgh, PA; Diagnostic Clinical Labs, Indianapolis, IN; and Reliance Pathology Partners, Tampa, FL.
These labs will perform the initial cytology and forward those cases deemed indeterminate to Interpace for molecular testing with ThyGenX and ThyraMir.
The Company has also completed its validation to perform ThyGenX and ThyraMir molecular testing using smear-based cytology slides in addition to the previous approvals for samples that were validated only on specimens from FNA biopsies that were preserved in RNA Retain.
A poster entitled "Molecular Analysis of Thyroid Malignancy Using Cytology Smears by Combined THYGENX™ and THYRAMIR™ testing: A Prospective Study", highlighting the clinical performance of the combined ThyGenX and ThyraMIR tests when carried out on FNA material smeared on cytology slides, was presented at the American Thyroid Association (ATA) Annual Meeting held in Denver September 19-23.
Some customers prefer to send this sample type for molecular evaluation, and the Company can now accept and process both methods of preparation.
According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules.