“Since Veracyte formed eight years ago, we have grown to now have two commercialized molecular diagnostics tests, with another test scheduled to launch this year,” Bonnie Anderson, Veracyte CEO told OutsourcingPharma.com.
This growth has been led by an increased test volume for its lead product, the Afirma Gene Expression Classifier (GEC). Specifically, this volume grew by 46% between 3Q 2014 and 3Q 2015.
To date, the company has performed more than 50,000 Afirma GEC tests, and in turn, has helped an estimated 25,000 patients avoid an unnecessary thyroid surgery. “[GEC] is becoming standard of care for resolving ambiguity in the diagnosis of thyroid cancer,” added Anderson.
The company’s second product, the Percepta Bronchial Genomic Classifier, was launched last April, and is designed to improve lung cancer diagnosis.
Anderson credits the company’s growth to its focus on fulfilling and unmet clinical need: diagnostic ambiguity.
“This is a major problem in healthcare that results in hundreds of thousands of unnecessary invasive procedures and billions of dollars in wasted healthcare costs in the U.S. each year,” she explained. “Not to mention the harmful impact of unnecessary procedures on patients. We develop genomic tests that resolve diagnostic ambiguity so that patients can avoid potentially unnecessary, costly and even risky surgeries or other invasive procedures, and costs can be removed from the healthcare system.”
In continuing to grow the business, the company is looking forward to expanding commercialization of its Percepta test, as well as launching another test in pulmonology, which is designed to improve idiopathic pulmonary fibrosis diagnosis.
“We also believe our focus on using genomics to resolve diagnostic ambiguity can be applied to multiple disease areas — and our additional space will give us the flexibility we need going forward,” added Anderson.
However, the molecular diagnostics industry is not without its challenges. According to Anderson, it can often be difficult to obtain reimbursement from insurance companies, which she described as the lifeblood for molecular diagnostics companies.
“We believe that our approach of offering clinically useful tests that change patient care and reduce costs — and of developing the rigorous clinical evidence to support our tests — positions us very well with payers,” she added.
For example, Veracyte’sAfirma GEC test is included in several thyroid guidelines and is covered by Medicare, in addition to many commercial insurance plans.
“In fact, we have nearly 175M lives under coverage and nearly 130M lives under contract for the test,” said Anderson. “We are optimistic about the future and expect to double our revenue in the next few years, with three commercialized products.”