9 October 2018 - - US-based genomic diagnostics company Veracyte, Inc. (NASDAQ: VCYT) has received new findings from six studies reinforcing the "real world" performance of the next-generation Afirma Genomic Sequencing Classifier and the Afirma Xpression Atlas in thyroid cancer diagnosis were presented at the 88th annual meeting of the American Thyroid Association, the company said.

The meeting was held October 3-7 in Washington, DC.

Researchers from leading institutions presented posters showing that use of the Afirma GSC at their respective centers significantly increased the identification of benign thyroid nodules among those deemed indeterminate not clearly benign or malignant following cytopathology review, compared to the original Afirma test.

The Ohio State University Researchers compared results of 113 indeterminate samples that were tested with the Afirma GSC to those of 403 samples using the earlier version of the test (the Afirma Gene Expression Classifier, or GEC).

The Afirma GSC identified 74.1% of the nodules as benign, compared to 48.4% with the GEC, an increase of 53%. The overall surgery rate among all patients who underwent genomic testing decreased by more than half from 42.2 % with the GEC to 20.2 % with the GSC.

Cleveland Clinic Comparing results of 46 samples tested with the Afirma GSC between July 2017 and December 2017 with 182 samples tested with the original test between December 2011 and July 2017, researchers found that the GSC identified 67.4% as benign, compared to 41.8% with the GEC an increase of 61%.

The overall surgery rate for nodules tested with the GSC was 32.6%, compared to 47.3% with the original test, a decrease of 31%.

Brigham and Women's Hospital Researchers evaluated results for 583 thyroid nodules tested with either the Afirma GSC or GEC (n=486) between 2011 and 2018. They found that the Afirma GSC identified 64.9 % of nodules as benign, compared to 47.9 % with the GEC, an increase of 35%.

Additionally, in two oral presentations, researchers shared the first "real world" Afirma Xpression Atlas data, providing insights into the distribution of a wide range of gene variants and fusions across key categories of indeterminate thyroid nodules and Afirma GSC results.

For example, among 13,549 indeterminate thyroid nodules evaluated using the Afirma GSC and Xpression Atlas, more than a quarter (25.9%) of GSC-suspicious nodules (in primary risk categories known as Bethesda III/IV) contained RAS variants. Additionally, RET, NTRK, BRAF and ALK fusions were only found in GSC-suspicious, versus GSC-benign, cases (in all Bethesda categories).

The field of precision medicine is progressing rapidly, and multiple targeted therapies are in clinical trials or have been approved for treatment of advanced cancers that harbor specific genomic alterations.

In the new data presented at the ATA conference, genomic changes (or alterations) targeted by these new therapies were identified in Afirma GSC-suspicious cases by the Xpression Atlas.

Veracyte's Afirma solution provides a comprehensive offering in thyroid cancer diagnosis for physicians evaluating patients with thyroid nodules.

The Afirma Genomic Sequencing Classifier combines RNA sequencing data with machine learning to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to avoid unnecessary surgery and preserve the thyroid.

Since the commercial introduction of Afirma in 2011, Veracyte has performed over 100,000 genomic tests, and estimates it has saved more than 40,000 patients from unnecessary thyroid surgery and removed an estimated USD 800m in surgery costs from the healthcare system.

The Afirma classifier is proven in over 20 published clinical studies, is included in most leading clinical guidelines and is covered as medically necessary by Medicare and all major US health plans.

The company's Afirma Xpression Atlas platform, introduced in May 2018, provides extensive genomic data that may inform surgery strategy and treatment options for patients with thyroid nodules that are suspicious for cancer or cancerous.

The RNA sequencing-based platform measures 761 DNA variants and 130 RNA fusions in over 500 genes shown to be associated with thyroid cancer on thyroid nodule fine needle aspiration samples.

Veracyte (NASDAQ: VCYT) is a genomic diagnostics company that improves patient care by providing trustworthy and actionable answers to challenging clinical questions.

The company's products uniquely combine advanced genomic technology, clinical science and machine learning to provide answers that give physicians and patients a clear path forward, informing both diagnosis and treatment decisions without the need for costly, risky surgeries that are often unnecessary. 

Since its founding in 2008, Veracyte has commercialised three genomic tests, which are transforming the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis and collectively target a USD 2bn market opportunity. Veracyte is based in South San Francisco, California.