CORRECTING and REPLACING Veracyte Announces Presentation of New Clinical Utility Data at CHEST 2017 Showing Percepta Classifier Reduces Invasive Procedures in Lung Cancer Diagnosis
Greater than 50 Percent Reduction in Patients Classified as Low Risk
for
The corrected release reads:
VERACYTE ANNOUNCES PRESENTATION OF NEW CLINICAL UTILITY DATA AT CHEST 2017 SHOWING PERCEPTA CLASSIFIER REDUCES INVASIVE PROCEDURES IN LUNG CANCER DIAGNOSIS
Greater than 50 Percent Reduction in Patients Classified as Low Risk
for
Data from the multicenter study that enrolled 390 patients demonstrated that when the Percepta test classified patients as low risk for lung cancer, there was greater than 50 percent relative reduction in recommendations for risky, costly, invasive diagnostic procedures compared to the recommendations made by the same physicians in the absence of the Percepta test result. The data also show that physicians elected to use the Percepta classifier 75 percent of the time in patients with the greatest probability of benefit from the test - those with low to intermediate pre-test risk of cancer.
"Patients with lung nodules that are not clearly benign or malignant
present a challenge to physicians and often are recommended to undergo
invasive procedures so that a lung cancer isn't missed," said
The Percepta classifier uses proprietary "field of injury" technology to
detect molecular changes in the lining of the respiratory tract of
current or former smokers, which are indicative of cancer or
cancer-related changes in the lung. The clinical utility data presented
today add to the library of clinical evidence supporting the Percepta
classifier, which includes positive clinical validation data published
in
"This prospective multicenter study provided the first, significant
real-world use of the Percepta classifier for the evaluation of lung
cancer," stated
The Percepta multicenter study measured the impact of the Percepta classifier on pulmonary lesion management in a prospective real-world clinical setting. The study enrolled over 390 patients who were former or current smokers without prior active cancer and who were deemed eligible for bronchoscopy following a pulmonary lesion on CT scan. A bronchial brushing was captured at the time of the bronchoscopy for genomic diagnostic evaluation of lung cancer by the Percepta classifier.
Lung cancer is the leading cause of cancer-related deaths in
About Percepta
The Percepta Bronchial Genomic Classifier is used to reduce unnecessary
surgeries and costs in lung cancer screening and diagnosis. The 23-gene
classifier combines gene expression data and machine learning to
effectively identify patients who are at low risk of lung cancer
following an inconclusive result from bronchoscopy - a nonsurgical
procedure that is commonly used to evaluate lung nodules. This can
enable these patients to be monitored with computed tomography (CT)
scans in lieu of invasive, risky and costly diagnostic procedures that
frequently prove to be unnecessary. The classifier's performance has
been verified in multiple, rigorous clinical studies, including clinical
validation data published in
About Veracyte
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, our beliefs with respect to the benefits of Percepta, including its ability to reduce unnecessary diagnostic surgeries in certain circumstances, improving patient care and reducing healthcare costs, and the applicability of clinical results to actual outcomes. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: demand for our tests, the applicability of clinical results to actual outcomes; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; the size of the market opportunity for our products; our ability to successfully achieve and maintain adoption of and reimbursement for our products; the amount by which use of our products are able to reduce unnecessary surgeries, improve patient care, and reduce healthcare costs; the occurrence and outcomes of clinical studies; the timing and publication of clinical study results; and other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.
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