Interpace Biosciences announced on October 21, 2021, that the United States Patent and Trademark Office has granted the company a patent (U.S. PTO Number 11,118,231 B2) for its innovative technology using microRNAs to distinguish benign from malignant thyroid neoplasms. The patent, issued on September 14, 2021, covers the underlying technology of the company's ThyraMIR® microRNA Classifier.
MicroRNAs are small, non-coding RNA molecules that bind to messenger RNA and regulate the expression of proteins involved in various human cancers, including thyroid cancer. This molecular mechanism forms the basis of Interpace's diagnostic approach.
The ThyraMIR® classifier is designed to work in conjunction with Interpace's next-generation sequencing-based ThyGeNEXT® test to risk stratify indeterminate thyroid nodules. By measuring the expression levels of 10 specific microRNAs, the combined testing approach provides clinicians with actionable "rule-in" and "rule-out" results.
"We are pleased to announce the approval of this patent by the US PTO," said Alidad Mireskandari, Ph.D., MBA, Chief Development Officer of Interpace Biosciences. "This patent adds to our existing portfolio of Intellectual Property that protects our innovative products and unique technology around the use of micro RNAs as key diagnostic analytes."
Clinical Significance of the Technology
Thyroid nodules are extremely common, with studies suggesting that up to 68% of the general population may have thyroid nodules detectable by ultrasound. However, only a small percentage of these nodules are malignant. The challenge for clinicians has been accurately identifying which nodules require surgical intervention.
Traditional cytopathology from fine needle aspiration biopsies classifies approximately 15-30% of thyroid nodules as indeterminate, creating diagnostic uncertainty. This uncertainty often leads to precautionary thyroidectomies, many of which are ultimately found to be unnecessary when final pathology confirms benign disease.
The ThyraMIR®/ThyGeNEXT® combination aims to address this clinical challenge by providing more definitive risk assessment, potentially reducing unnecessary thyroid surgeries and improving overall patient care and outcomes.
Expanding Molecular Diagnostic Portfolio
This patent approval strengthens Interpace Biosciences' position in the molecular diagnostics market. The company has been developing a suite of diagnostic tools focused on enabling personalized medicine approaches across various conditions.
Interpace Biosciences operates as a fully integrated commercial company providing clinically relevant molecular diagnostic tests and pathology services. Their focus on specialized services spans the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.
The company trades on the OTCQX market under the ticker symbol IDXG and continues to build its intellectual property portfolio to protect its innovative diagnostic technologies.
Market Impact and Future Directions
The thyroid diagnostics market is projected to grow significantly in the coming years due to increasing incidence of thyroid disorders and the push toward more precise diagnostic methodologies. Molecular testing approaches like those developed by Interpace represent an important advancement in this field.
With this patent approval, Interpace Biosciences secures its competitive position in the thyroid cancer diagnostics space, potentially opening doors for expanded applications of its microRNA technology in other cancer types and clinical scenarios.
As the field of molecular diagnostics continues to evolve, technologies that can accurately differentiate between benign and malignant conditions will play an increasingly important role in clinical decision-making, potentially reducing healthcare costs while improving patient outcomes.
