The article describes how the technology behind Veracyte's Afirma Genomic Sequencing Classifier and Xpression Atlas is helping to reduce unnecessary surgeries in thyroid cancer diagnosis, and also inform surgery and treatment decision-making using the same minimally invasive patient sample.
The article is highlighted on the cover of the June print issue, which is scheduled to be available the week of June 17, 2019.
Challenges involved in the management of thyroid nodules include: Differentiating benign from malignant thyroid nodules when cytopathology results are indeterminate; determining the extent of initial thyroid surgery needed; and identifying targeted treatments for patients with thyroid cancers that do not respond to standard treatment.
The article, titled "Extending Expressed RNA Genomics from Surgical Decision Making for Cytologically Indeterminate Thyroid Nodules to Targeted Therapies for Metastatic Thyroid Cancer," describes the development of and evidence behind the Afirma GSC and XA.
Both tests leverage RNA whole-transcriptome sequencing technology to measure gene expression in potentially cancerous thyroid nodules.
The authors note that RNA transcriptome technology may provide advantages over DNA-based genomic findings because it reflects a nodule's current genomic activity, as compared to DNA-based approaches, which may show inactive gene mutations.
Two targeted therapies are now approved by the US Food and Drug Administration for treating thyroid cancer patients: a combination of dabrafenib plus trametinib for BRAF V600E-mutated anaplastic thyroid cancer; and larotrectinib for solid tumors harboring a NTRK gene fusion, regardless of cancer type.
Additionally, multiple other recent clinical trials have investigated therapies with specific targets that are relevant for thyroid cancer. These include two compounds targeting RET alterations, which were the subject of new data presentations at the recent American Society of Clinical Oncology annual meeting.
The Afirma XA identifies these gene alterations, which can help physicians determine which patients could benefit from these cutting-edge new treatments.
The Afirma GSC and Xpression Atlas provide physicians with a comprehensive solution for a complex landscape in thyroid nodule diagnosis and individualization of care. Veracyte developed the Afirma GSC with RNA whole-transcriptome sequencing and machine learning.
The test helps identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to help patients avoid unnecessary diagnostic thyroid surgery.
Afirma GSC testing is widely used in thyroid cancer diagnosis and is covered by Medicare and most of the nation's leading private health insurers. The Afirma XA provides physicians with genomic alteration content from the same fine needle aspiration samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients.
The Afirma XA includes 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer.
The American Cancer Society estimates that 52,070 people in the United States will be diagnosed with thyroid cancer this year. Each year in the United States approximately 525,000 patients undergo FNA biopsies to evaluate thyroid nodules for cancer.
Up to 30% of these patients receive indeterminate results meaning they are not clearly benign or malignant and, historically, most were directed to diagnostic surgery even though 70% to 80% of the time the nodules ultimately proved to be benign.
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 commercialized five genomic tests, which are transforming the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis. Veracyte is based in South San Francisco, California.
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