Interpace Biosciences Announces New Clinical Validation Data; Diagnostic Accuracy Significantly Improved
PARSIPPANY, NJ -- Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX: IDXG), a fully integrated commercial company that provides clinically relevant molecular diagnostic tests and pathology services for improved patient diagnosis and management, today announced new clinical validation data for their thyroid cancer test platform which is comprised of a mutation panel (ThyGeNEXT®) and a microRNA (miRNA) risk classifier. The new data demonstrates that the addition of miRNA pairwise expression profiling (ThyraMIR®v2) provides clinically and statistically superior risk stratification of indeterminate thyroid nodules (ITN) beyond that of the algorithmic classification analysis provided by the original ThyraMIR® assay.
ThyraMIRv2 was developed and validated in a fully blinded cohort (n=197) from a previous retrospective validation study. The new data analysis revealed improvement in the number of true negative results and reduction of false positive results with a subsequent improvement in the specificity and PPV at positive threshold, while preserving a high sensitivity and NPV. The ROC AUC increased from 0.85 to 0.97 (pp RAS-like (weak driver) mutations, minimally invasive follicular carcinomas, low-grade PTC, and Hürthle cell predominant nodules—providing significant improvement in test accuracy and the highest NPV and PPV of commercially available tests. The study has recently been published in THYROID®, the leading peer-reviewed journal for original research on thyroid cancer, and can also be accessed by visiting www.thyroiddx.com/pairwise.
Dr. Syd Finkelstein, Chief Scientific Officer of Interpace Diagnostics, commented that “miRNA analysis may also reduce the risk of RNA sampling error because miRNAs can migrate throughout the thyroid nodule. As a result, they may be less affected by spatial variability than the distribution of cells with DNA mutations.“
Further commenting was Dr. Carl Malchoff, Professor Emeritus, Medicine/Endocrinology, Founder of the Endocrine Neoplasia Program at UConn Health, and a co-author of the manuscript, “The addition of pairwise microRNA expression profiling represents a clinically important development in precision molecular diagnosis of indeterminate thyroid nodules. For 87% of samples, the positive and negative predictive values are ≥90% across a broad range of cancer prevalence (16% to 84%). Furthermore, as with earlier versions, this assay is performed using fresh FNA samples or diagnostic cytology slides, eliminating the need for an additional biopsy, refrigerated storage, or special shipping.”
Tom Burnell, PhD, President and CEO of Interpace Biosciences, added: “Mutational analysis alone is often insufficient to accurately “rule-in” or “rule-out” malignancy in indeterminate thyroid nodules. We have previously demonstrated the utility of pairwise miRNA analysis in the diagnosis of medullary thyroid cancer and are excited to be able to bring this more precise risk estimation to clinicians, who must integrate various risks and benefits when deciding for or against surgery.” He further stated, “The diagnosis and prognosis of thyroid and other cancers aligns fully to the Interpace corporate goal of improving healthcare by enabling personalized medicine.”