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Snapshot: Veracyte

Name: Bonnie Anderson
Title: Co-Founder and CEO
Company: Veracyte
Location: South San Francisco, CA
Social Media: @veracyte
Year Founded: 2008
Number of Employees: 90
Description: Veracyte is pioneering the emerging field of molecular cytology, developing and commercializing genomic tests that are designed to improve the diagnostic accuracy of cytology samples that are obtained via minimally invasive means. Our novel tests are intended to empower doctors to make better and more efficient treatment decisions early, thus helping patients avoid unnecessary invasive procedures, while reducing health care costs.
Products or Pipeline, Phase: We launched our Afirma® Thyroid FNA Analysis, which is based on our novel Afirma® Gene Expression Classifier, in early 2011.
We are developing additional genomic tests to incorporate into our Afirma Thyroid FNA Analysis.
We are in early biomarker discovery for lung cancer and interstitial lung diseases products.

What do your diagnostics detect?

Our first product is based on the Afirma Gene Expression Classifier, a genomic test, which helps resolve inconclusive thyroid nodule fine needle aspiration (FNA) results – a common problem in thyroid cancer diagnosis. The test evaluates the expression patterns of 142 genes to reclassify inconclusive thyroid FNA samples as benign or suspicious for cancer. A prospective, multicenter clinical validation study, published in the New England Journal of Medicine, demonstrated our test’s ability to reclassify inconclusive thyroid nodule FNA results as benign with a high degree of accuracy, suggesting its potential to help tens of thousands of patients each year avoid unnecessary thyroid-removal surgery.

What are some of the hurdles in developing effective new diagnostics?

Reimbursement can be challenging for new diagnostics. That is why it is so important to address reimbursement issues early in the process, including meeting with payers to understand their needs and initiating studies to develop the cost-effectiveness and other data that payers will require.

What are some new approaches that you are using to diagnose diseases?

We believe the most important work in the development of a diagnostic is determining the right question to ask to change patient care and positively impact the cost of care. Many diagnostics detect the presence of disease. With our Afirma Gene Expression Classifier, however, we take a novel approach of using gene expression testing to identify – with a high degree of accuracy – patients with benign thyroid nodules, among those with an inconclusive result by cytopathology, who otherwise would go to surgery. This approach provides physicians with the information and confidence they need to follow the patient with watchful waiting in lieu of a thyroidectomy. This can significantly improve patient quality of life, while reducing health care costs.

How have diagnostics changed in the past decade? What have been the factors in this change?

Genomic approaches available today provide potential answers to an endless list of new clinical questions. The biggest shift we have seen has been a reluctance on the part of payers to cover these tests unless they answer the right clinical questions and are supported by a robust body of evidence.

Where do you see diagnostics going in the future?

We believe that diagnostics will play an ever-increasing role in helping physicians personalize care. The ability to utilize sophisticated technology to unlock molecular information allows physicians to provide patients with personalized treatment options in a way that was unthinkable a generation ago.

What effect will this have on the industry? On patients?

The day of one-size-fits-all treatment models and therapy options is coming to end. This shift has profound implications to lower the costs of care while improving quality. The challenge will be how to build the robust evidence necessary to have our products and approaches reimbursed to the level that justifies the investments to effect this revolution.

What helps you continue to innovate?

Understanding the impact of clinical problems and challenges on patients is what drives us to innovate. We are driven by hearing their stories about the uncertainty and procedures that they undergo in the effort to understand their health status. We are inspired and humbled by our ability to dramatically simplify these clinical challenges for patients by utilizing genomic technology to unlock answers to critical medical questions – before the patient has to go to surgery.

Why do you think California has been leading in the life science industry?

California offers a unique ecosystem of scientific excellence, institutional leadership in health care and VC funding, which is key to driving innovation. California is home to successful companies that spur new start-ups, as well as the multi-functional expertise that is widely available through consultants. The latter can help support the early stages of a company’s formation and growth when hiring that expertise full-time is not possible.

Why is innovation important to the life science industry?

The industry is fueled by innovation – from new technologies to innovative clinical trials to the emergence of drugs and diagnostics that offer the promise of better patient care at reduced costs. Our industry’s very existence depends on our collective ability to rapidly and continuously innovate in all areas of business.

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