US-based specialised molecular diagnostic tests and pathology services provider Interpace Diagnostics Group has introduced two new thyroid services, ThyGenX and ThyraMIR testing.
The services are expected to produce an estimated 400 new specimens in the first 45 days following the initial launch.
ThyGenX and ThyraMIR testing is designed to determine the presence and absence of cancer in thyroid nodules.
ThyGenX uses next-generation sequencing (NGS) to distinguish more than 100 genetic alterations corresponding to papillary and follicular thyroid carcinomas.
ThyraMIR is the first microRNA gene expression classifier.
The company's new cytopathology service is fabricated to help physicians and clinics that favour the initial Fine Needle Aspirate (FNA) biopsy evaluated by an independent third party versus having it performed on site.
The cytopathology service will be provided by the pathology labs, Allegheny General Hospital, Diagnostic Clinical Labs; and Reliance Pathology Partners.
These labs will evaluate the initial cytology for cancer risk and forward those cases concluded to be indeterminate to Interpace for molecular testing with ThyGenX and ThyraMir.
The company has obtained approvals for samples that were validated only on specimens from FNA biopsies that were preserved in RNA Retain.
In addition, it has also performed the validation of these services using smear-based cytology slides.
Interpace company president and chief executive officer said: "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."