Hawkeye Bio and HealthQuest Esoterics Launch LEAP Blood Test for Early Lung Cancer Detection

Hawkeye Bio and HealthQuest Esoterics have partnered to bring the LEAP blood test to market, aiming to support early detection of lung cancer. This collaboration pairs Hawkeye Bio's biosensor technology with HealthQuest Esoterics' clinical laboratory expertise and established delivery infrastructure, setting the stage for the development of additional diagnostic applications.

Lung cancer remains the leading cause of cancer deaths in the United States, projected to claim the lives of approximately 125,000 Americans in 2026. Despite the high mortality rate, fewer than one in five of the estimated 14.2 million U.S. adults eligible for lung cancer screening according to the U.S. Preventive Services Task Force (USPSTF) guidelines are up to date with their annual screenings. This gap in screening represents a significant public health challenge.

The LEAP blood test, developed by Hawkeye Bio, is designed to provide early biological information for additional physician assessment alongside low-dose CT screening, which is the current standard for lung cancer detection. A negative LEAP result does not rule out lung cancer, and an abnormal result recommends further clinical evaluation. The test measures patterns of protease activity associated with lung cancer, offering a different perspective on disease biology compared to traditional biomarker tests.

HealthQuest Esoterics has independently validated the LEAP clinical performance within the formal analytic validation of the commercial test. The study demonstrated 95% sensitivity across all lung cancer stages and subtypes, with a projected negative predictive value of 99.9% in the intended use population. This means a negative result is highly likely to correctly indicate the absence of cancer. LEAP is currently available as a self-pay laboratory-developed test (LDT) and is not covered by insurance. It has not been cleared or approved by the FDA.

Tom Giancursio, CEO of HealthQuest Esoterics, emphasized the company's commitment to providing reliable and responsive service to healthcare providers.

Paul Dempsey, Chief Science Officer and co-founder of Hawkeye Bio, explained the unique approach of the LEAP test.