Exact Sciences Corp. and Mayo Clinic have recently released a study by the American Association of Cancer Research (AACR) which shows promise for the development of a blood-based lung cancer test. Researchers conducted a multi-round study of nearly 400 patients, which demonstrated high accuracy for detecting lung cancer at all stages.

"These results reveal an opportunity to detect lung cancer from a simple blood draw," said Kevin Conroy, chairman and CEO of Exact Sciences. "Our collaboration with Mayo Clinic is efficiently identifying biomarkers for additional cancer applications on the same technology platform as Cologuard."

AACR released an abstract of the study, ahead of the presentation of the results on April 2, 2017, during the AACR 2017 annual meeting. The findings from the study of 398 patients (311 controls and 87 cancers) demonstrate that biomarkers in plasma achieved high accuracy for all types and stages of lung cancer. Using two independent regression modeling approaches, a panel of four novel methylated DNA markers demonstrated a sensitivity of 91-96 percent at a specificity of 90-94 percent.

"More studies are needed to corroborate accuracy, however, this plasma DNA test approach appears to be a promising new method and may serve as a rational follow-up to the common findings of lung nodules on CT scanning and may have application in screening for lung cancer," said David E. Midthun, MD a pulmonologist at Mayo Clinic.

Lung cancer is the leading cause of cancer mortality, resulting in 1.7 million deaths globally and more than 150,000 deaths in the United States every year. Most symptoms present in the late stages of the disease, when the survival rate is only four percent. Early detection of lung cancer offers the opportunity to reduce mortality. Lung cancer screening is approved for smokers using chest CT scanning. This approach has a sensitivity for lung cancer above 90 percent, but its specificity may fall below 75 percent (a false positive rate of more than 25 percent) because indeterminate lung nodules are so common. Evaluation of these false-positives leads to unnecessary, costly and potentially harmful procedures.

"A blood-based test may help guide next steps after a scan reveals an indeterminate nodule," Mr. Conroy said. "For example, a positive blood test might suggest the need for a biopsy or surgery. In contrast, a negative test might suggest a less aggressive approach. Such a test could offer the opportunity to significantly improve health outcomes and reduce the financial impact on the health care system."