Veracyte Announces Presentation of New Clinical Utility Showing Percepta Classifier Reduces Invasive Procedures in Lung Cancer Diagnosis

What Kind of Equipment is Used to Analyze DNA?

Below are some of a few basic processes followed throughout DNA testing. The general procedure entails:  • Isolating DNA from a sample containing the needed...

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

The findings were presented in an oral session at CHEST 2017, the annual meeting of the American College of Chest Physicians, being held October 28 to November 1 in Toronto, Canada.

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.

Hans J. Lee, M.D., associate professor of medicine at the Johns Hopkins University School of Medicine, who presented the data said, “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.”  He added, “Our findings suggest that patients classified as low risk by the Percepta classifier were monitored with CT imaging rather than being directed to surgery. In broader clinical practice, this can help to reduce surgeries and costs in lung cancer diagnosis and becomes increasingly important as more lung nodules are found through expanded lung cancer screening.”

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 The New England Journal of Medicine. It also follows the recent positive Medicare coverage policy for the test by the Centers for Medicare & Medicaid Services’ MolDx program.

Neil Barth, M.D., Veracyte’s chief medical officer added, “This prospective multicenter study provided the first, significant real-world use of the Percepta classifier for the evaluation of lung cancer.”  He went on to say: “It not only substantiates the results from our clinical validation study, it further shows that, in practice, physicians use the test as intended and that their treatment decision is impacted by the Percepta test results. This translates to better patient care and far fewer costly invasive diagnostic procedures.”

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 the United States – more than the next three leading cancers combined. Early detection through CT screening can dramatically reduce deaths by detecting lung cancer early, when it is most treatable. Annual CT screening is now covered by Medicare and most private insurance companies for the 8.6 million Americans who are at increased risk of lung cancer. Bronchoscopy is often used to evaluate potentially cancerous lung nodules found on CT scans. Among the estimated 350,000 patients who undergo such a bronchoscopy each year, however, up to 70 percent receive results that are inconclusive. This frequently leads to patients undergoing potentially risky, expensive and unnecessary invasive procedures, including transthoracic needle biopsy (TTNB) and surgical lung biopsy (SLB), to obtain a more definitive diagnosis.

spot_img

DON'T MISS

Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles