Exact Sciences Corp. and The University of Texas MD Anderson Cancer Center today announced an agreement to jointly develop and commercialize blood-based screening and diagnostics tests for the early detection of lung cancer.
This unique collaboration seeks to build upon MD Anderson's extensive research into predictive biomarkers for lung cancer and Exact Sciences' successful development and commercialization of Cologuard®, the only FDA-approved, non-invasive colon cancer screening test. The two groups plan to develop a groundbreaking new blood test that targets biomarkers associated with lung cancer.
The collaboration specifically aims at developing a blood-based lung cancer screening test to determine the need for low-dose computed tomography. This test would offer the opportunity to screen nearly 11 million Americans considered high-risk smokers and former smokers. The partnership is also aimed at developing a diagnostic test to determine the malignant status of nodules found through low-dose CT screening. This test would be valuable to nearly 4 million Americans diagnosed with lung nodules each year.
"Lung cancer is, and will continue to be, America's leading cancer killer unless we identify new approaches to diagnose it early, at its most treatable stages," said Sam Hanash, M.D., Ph.D., director of MD Anderson's Red and Charline McCombs Institute for the Early Detection and Treatment of Cancer. "Our collaboration with Exact Sciences provides a great opportunity to create tests that could shift the lung cancer detection paradigm for the benefit of patients."
"Our common vision is to help win the war on cancer through early detection. Taking on lung cancer offers an opportunity to build on the success of Cologuard," said Exact Sciences' Chairman and CEO Kevin Conroy. "A simple blood test to complement a LDCT scan could significantly improve early-stage lung cancer detection. Our experience working with regulators and insurers coupled with MD Anderson's world-class research and development capabilities are an ideal match to make a meaningful difference in the war on cancer."
The American Cancer Society estimates that lung cancer will be diagnosed in 221,200 Americans and cause 158,040 deaths in the United States this year. Currently, more than half of lung cancer cases are diagnosed at an advanced stage, after symptoms appear, when the five-year survival rate is in the low single digits. If detected at an early stage, lung cancer's five-year survival rate can be as high as 80 percent.
Hanash's research spans a variety of biomarker types - including DNA, proteins, metabolites, autoantibodies. "Our goal is to choose the best-performing biomarkers for our panel across multiple technologies," Hanash said, as opposed to the more common practice of relying on a single type of biomarker.
The initiative is part of MD Anderson's Moon Shots Program, a goal-oriented, multidisciplinary effort harnessing available knowledge and new disruptive technologies to dramatically reduce cancer mortality through prevention, early detection and curative treatments. The program's innovative approach focuses initially on eight cancers: lung, breast, ovarian, prostate, melanoma, chronic lymphocytic leukemia, myelodysplastic syndromes and acute myeloid leukemia. Early detection was chosen as a flagship project of the Lung Cancer Moon Shot, funded initially by the Lyda Hill Foundation.
Currently low-dose CT scanning is reimbursed by Medicare for high-risk smokers and received a Grade B rating from the U.S. Preventive Services Task Force, leading clinicians nationwide to increase screening programs in recent years. The clinical challenge is that while low-dose CT scanning is about 94 percent sensitive, it has a 73 percent specificity for the initial screen. As a consequence of the lower specificity of CT, 96 percent of all nodules discovered via scans are benign, leading to unnecessary and often harmful invasive procedures, radiation exposure and high costs. More information about improving lung cancer detection with a new cost-effective blood-based test is available in this report from Exact Sciences.
Hanash also holds the Evelyn and Sol Rubenstein Distinguished Chair for the Cancer Prevention Department and is a professor of Clinical Cancer Prevention at MD Anderson.