PRESS RELEASE: 3 November 2020, 07:00 CET
Under the terms of the agreement, GeneproDx will take the lead in the development of the Idylla™ ThyroidPrint® test, whereas
Thyroid nodules are very common and are often detected during routine medical exam or by patient self-assessment. Only some 10% of fine needle aspirate (FNA) biopsy procedures1 reveal the presence of malignant cells, while approximately 70% confirm a benign (non-cancerous) diagnosis. The remaining 20% are reported as indeterminate, meaning that no certain diagnosis can be provided to physician and patients2. Annually, over 1.2 million thyroid cytology evaluations are reported as indeterminate3. In patients with such result, diagnostic surgery of the thyroid gland is frequently recommended4. The risk of malignancy in these indeterminate cases is estimated to be between 15-35%, meaning that surgical intervention is unnecessary in up to 65-85% of these cases4.
ThyroidPrint® is a qRT-PCR5 based mRNA-expression classifier6 test that helps to determine whether a thyroid nodule with an indeterminate cytology result is benign or malignant7. A benign test result8 allows physicians to recommend watchful waiting as an alternative to diagnostic surgery. This prevents exposing patients to surgical risks and permanent thyroid hormone supplementation. Moreover, it significantly reduces health costs associated with unnecessary surgery3.
GeneproDx’s ThyroidPrint® was initially clinically validated in a multicenter trial in
Herman Verrelst, Chief Executive Officer of
Hernán González MD, PhD, Professor of Surgery at the
Development of the ThyroidPrint® on Idylla™ will be initiated in Q4 2020.
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Head of
e-mail rdegrave@biocartis.com
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GeneproDx
Head of Corporate Communications GeneproDx
email fmena@geneprodx.com
tel +569 5608 654
About
About GeneproDx
GeneproDx’s mission is to offer patients with indeterminate thyroid nodules the highest quality of precision medicine through ThyroidPrint®. GeneproDx’s vision is to be pioneers and leaders in the diagnosis of patients with indeterminate thyroid nodules in
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1 In FNA biopsy procedures, approximately 350,000 of which are performed annually in the US alone (Popoveniuc G, Jonklaas J. Thyroid nodules.
2 Faquin WC, Bongiovanni M, Sadow PM 2011 Update in thyroid fine needle aspiration. Endocrine pathology 22:178‐183.
3
4 To determine the true nature of the nodule as standard practice. Haugen BRM, Alexander EK, Bible KC, Doherty G, Mandel SJ, Nikiforov YE, Pacini F, Randolph G, Sawka A, Schlumberger M,
5 Quantitative Reverse Transcription PCR. PCR or Polymerase chain reaction is an efficient and cost-effective way to copy (amplify) small segments of DNA or RNA. As such, millions of copies of a section of DNA are made in just a few hours, allowing further analysis for clinicians to diagnose and monitor diseases using a minimal amount of sample, such as blood or tissue. Source: www.genome.gov, last consulted on
6 Based on RTqPCR analysis, combined with an advanced machine learning algorithm
7 This means that the probability of the nodule being malignant drops from 25% to less than 5%, allowing follow-up to be recommended as an alternative to surgery. Info and source: https://thyroidprint.com/en/home-us/, last consulted on
8 NPV (Negative Predictive Value) > 95%
9
10 Results are expected end of
11 Dominguez et al., ThyroidPrint: Preliminary Clinical Utility Experience. Archives of Endocrinol & Metab Vol 63, Suppl 02, pp 81 – 2019
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