In an important advancement for patients – and personalized medicine in general – Veracyte’s Afirma Genomic Sequencing Classifier (GSC) now has expanded Medicare coverage for use in patients with “Bethesda V” thyroid nodules, or those that are suspicious for cancer. This expanded coverage stems from a new Local Coverage Determination through the MolDX program and will give thousands of such patients access to advanced technology to help guide their treatment based on the molecular characteristics of their nodules. This milestone also reinforces Veracyte’s leadership in cancer diagnostics and the power of our novel Veracyte Diagnostics Platform.
Understanding Bethesda V and Its Implications
Bethesda V refers to a higher-risk category of thyroid nodules from the Bethesda System for Reporting Thyroid Cytopathology This system provides a standardized approach to classifying thyroid fine needle aspiration (FNA) biopsies according to their likelihood of being cancerous, based on cytopathology review. Of the approximately 600,000 patients each year who undergo FNA biopsies for thyroid nodules,1 approximately 30,000 are classified as Bethesda V, or B-V.2 Because these nodules have a high rate of malignancy (50%-75% 2), such patients are typically managed by surgery in which all or part of the thyroid gland is removed.
A challenge for their clinicians is, what type of surgery to perform? If they remove the whole thyroid, patients will require lifelong daily thyroid hormone replacement therapy to maintain their metabolism, mood and energy levels in check. That’s considerably more negatively impactful than preserving the thyroid, especially since many thyroid cancer patients, most often women, are diagnosed rather early in their lives – in their 40s and 50s.
On the other hand, if a less-comprehensive surgery, such as a lobectomy or hemi-thyroidectomy, is performed and the patient turns out to have an aggressive cancer, then they may need to undergo additional surgery or risk their cancer progressing. Determining which kind of surgery to perform – before the surgery happens – is where the Afirma GSC can help patients with B-V thyroid nodules the most.
Afirma GSC: Providing more personalized patient care
For patients with suspected thyroid cancer, the Afirma GSC uses advanced genomic technology to provide critical information to help clinicians determine how the cancer will behave. This includes the largest panel of thyroid genes and fusions, which have been clinically validated and informed by The Cancer Genome Atlas, published literature, and Veracyte’s scientists analyzing nearly 40,000 thyroid FNA samples. Among these are the BRAF V600E, NTRK and RET gene variants, which are associated with more-aggressive cancer. In fact, new therapies are available or in development to target these variants. Just last week, the FDA approved a drug for certain patients with metastatic RET fusion-positive thyroid cancer. The Afirma GSC also identifies medullary thyroid cancer (MTC), a particularly aggressive type of disease, with high accuracy.
The pioneering Afirma GSC was developed with RNA whole-transcriptome-derived sequencing and machine learning technology. Its initial focus was to help clinicians identify patients with benign thyroid nodules among those with indeterminate FNA biopsy results (known as Bethesda III and IV) based on cytopathology review (the test does not rule out surgery for patients with Bethesda V nodules). Thyroid FNAs are often inconclusive and, historically, these patients were directed to surgery, even though up to 80% of the time the patient’s nodule proved to be benign, meaning the surgery was unnecessary.3-6
The Afirma GSC’s high sensitivity (91%) and negative predictive value (96%)7 for ruling out cancer have been proven in numerous peer-reviewed published papers and abstracts, giving clinicians confidence to avoid surgery for patients with benign Afirma GSC results and opt for monitoring instead. The Afirma GSC is covered by Medicare and most private insurers for this purpose. In fact, Veracyte estimates that Afirma testing has helped more than 175,000 patients avoid unnecessary surgery since the test was commercially introduced in 2011.
With the expanded Medicare coverage, a broader patient population will now have access to Afirma testing to help inform surgical strategy and potentially other treatment decisions when thyroid cancer is suspected. Our hope is that more private insurance companies will follow Medicare’s lead and similarly cover Afirma testing for patients with B-V thyroid nodules so that more people can benefit from this tool.
The Veracyte Diagnostics Platform: Innovating for Better Patient Outcomes
Afirma’s success in transforming care for patients with thyroid nodules and thyroid cancer reflects the power of Veracyte’s overall approach to cancer diagnostics. We refer to this novel approach as the Veracyte Diagnostics Platform and it drives our efforts in other diseases, including prostate, breast, bladder and lung cancer.
The Veracyte Diagnostics Platform typically begins with our whole-transcriptome sequencing approach, in which we capture vast amounts of data from a wide range of patient samples and combine this with advanced machine learning to create high-performing tests. We then collaborate with leading clinicians and researchers to demonstrate our tests’ clinical performance and utility, which helps fuel adoption, guideline inclusion and reimbursement. Because we are querying the whole transcriptome with every sample tested, we can – in the case of Afirma – provide extensive information about gene expression and genetic variants in each patient’s tumor as part of the one test.
We also are pleased to collaborate with the research community in the case of our Afirma GRID tool to generate more data through our whole-transcriptome sequencing approach to help further advance scientific understanding of thyroid tumor biology. We believe this will ultimately lead to more innovation and opportunities to further personalize patient care.
I’m proud of the way the Veracyte team worked through the review of the Local Coverage Determination draft, provided input during the open-comment period and helped arrive at this point where expanded Medicare coverage for Afirma testing will help make more-personalized, clinical management decisions available to more patients. It marks just one of the latest advances in how we are collectively realizing the potential of genomic and other technology to improve care for patients – helping the right patients get the right interventions at the right time. It’s an exciting time to be in the life sciences field and I’m especially excited about the work we are doing at Veracyte to positively impact people’s lives in meaningful ways.
Feel free to reach out if you have any questions or if you’d like to learn more about how the Afirma GSC and the Veracyte Diagnostics Platform are helping to revolutionize patient care.