Veracyte, Inc. (NASDAQ: VCYT), a molecular diagnostic company pioneering the field of molecular cytology, today announced the launch of its Percepta™ Bronchial Genomic Classifier, a new genomic test to resolve ambiguity in lung cancer diagnosis. The company will soon begin testing patient samples in its CLIA-certified laboratory, with the Percepta test now available to a limited number of institutions around the country.
The Percepta test is designed to reduce the number of invasive biopsies and other procedures that can follow when suspicious lung nodules are found on computerized tomography (CT) scans. The test is used when results from a bronchoscopy - a common nonsurgical procedure to evaluate lung nodules - are non-diagnostic, meaning that cancer cannot be ruled out. Data from a prospective, multicenter clinical validation study previously demonstrated the Percepta test's ability to identify patients whose lung nodules are at low risk of malignancy so that they can be monitored with CT scans in lieu of invasive diagnostic procedures.
"Our Percepta test can help patients avoid unnecessary, potentially risky procedures while simultaneously reducing the growing cost burden associated with lung cancer diagnosis," said Bonnie H. Anderson, Veracyte's president and chief executive officer. "We believe the clinical and public-health need for the Percepta test becomes even greater as more patients become eligible for new lung cancer screening programs."
Ms. Anderson noted that, beginning in early 2015, more than eight million Americans at high-risk for lung cancer became eligible for annual screening with low-dose CT (LDCT) through new private-insurer and Medicare coverage requirements.
"Bronchoscopy is attractive to clinicians and patients because it offers a nonsurgical method for diagnosing suspicious lung nodules. However, given the difficulty in accessing small peripheral nodules, it often produces non-diagnostic results, leaving clinicians with the dilemma of whether to subject patients to invasive and potentially unnecessary diagnostic procedures or just monitor them with CT scans, with the risk that they may have cancer," said Avrum Spira, MD, M.Sc., professor of medicine at Boston University and co-developer of the genomic test. "The Percepta test can help determine a lung nodule's likelihood of cancer, without the need to sample the nodule directly, which should provide very tangible benefits to patients, medical professionals and the healthcare system."
Veracyte's test comprises a 23-gene molecular classifier that uses proprietary "field of injury" technology to detect molecular changes that occur in the epithelial cells lining the lung's respiratory tract in response to smoking - the cause of 85-90 percent of lung cancers. These changes can be detected in cells obtained from standard cytology brushings taken during bronchoscopy from the proximal airway, and indicate the presence of malignancy or disease processes from distant sites in the lung.
An estimated 250,000 patients currently undergo a bronchoscopy each year in the U.S., with approximately 40 percent producing non-diagnostic results. These numbers are expected to increase significantly with the new insurance coverage requirements for annual CT screening. Veracyte noted that it does not expect meaningful revenue from the Percepta test until 2017.
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