Veracyte Inc., based on South San Francisco, California, recently announced it has been authorized by the New York State Department of Health to offer the Percepta Bronchial Genomic Classifier for patients in that state.
Percepta is designed to reduce the number of invasive biopsies and other procedures, using a 23-gene test to identify patients with lung nodules following an inconclusive bronchoscopy in patients who are at low risk (less than 10 percent) of developing lung cancer, and who can be considered for monitoring through computerized tomography (CT).
“We are delighted that the Percepta Bronchial Genomic Classifier will now be available to physicians and their patients in New York State,” Bonnie Anderson, Veracyte’s president and chief executive officer, said in a press release. “This significant milestone underscores the clinical need for and strength of the validation data supporting our test. We look forward to offering the Percepta test in New York State as we continue its initial rollout to select institutions around the country.”
Chest imaging is used to identify lesions suspicious of lung cancer. The decision to pursue surveillance imaging or an invasive evaluation involves an assessment of the probability of cancer, the ability to biopsy, the surgical risk, and the preferences of the patients. When a biopsy is required, the methodology can include bronchoscopy, transthoracic needle biopsy, or surgical lung biopsy.
Bronchoscopy is a safe procedure, and in the U.S. around 500,000 bronchoscopic examinations are performed every year. However, bronchoscopy is limited by its sensitivity, which ranges from 34 to 88 percent, depending on the lesion location and size. Even with newer bronchoscopic guidance techniques, the sensitivity for the detection of lung cancer is only about 70 percent for peripheral lesions.
This diagnostic challenge is expected to rise, given that an estimated 8 million Americans became eligible for annual lung cancer screening in 2015 through new insurance coverage requirements.
The Percepta Bronchial Genomic Classifier has been clinically proven in three rigorous multicenter studies with more than 1,000 patients enrolled across more than 30 medical centers, including the prospective, multicenter AEGIS I and AEGIS II studies. Percepta was found to improve the diagnostic performance of bronchoscopy for the detection of lung cancer. Data of the proven efficacy of the classifier was recently published in The New England Journal of Medicine in an article titled “A Bronchial Genomic Classifier for the Diagnostic Evaluation of Lung Cancer.”
The Percepta test may now be offered to patients with inconclusive bronchoscopy results under Veracyte’s current laboratory permit with the New York State Department of Health, while the agency completes its final review.
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