With lung cancer projected to kill roughly 125,000 Americans in 2026, a new blood test is now commercially available, aiming to bridge a deadly screening gap. Irvine, California-based Hawkeye Bio and HealthQuest Esoterics have announced the launch of LEAP (Lung Enzyme Activity Profile), a prescription blood test designed to support early lung cancer detection and work alongside standard low-dose CT screening.
The test leverages Hawkeye’s proprietary graphene biosensor technology to analyze patterns of protease enzyme activity associated with lung cancer. All testing is performed at HealthQuest’s CLIA-certified laboratory in Irvine, with results delivered to physicians within seven days of sample receipt.
This partnership merges Hawkeye’s research and assay development with HealthQuest’s clinical laboratory validation, physician relationships, and specimen-collection network. The companies view this as a foundational step for bringing additional diagnostic applications into clinical use as they are developed.
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The urgency is clear: fewer than one in five of the estimated 14.2 million U.S. adults eligible under U.S. Preventive Services Task Force (USPSTF) criteria reported being up to date with their annual lung cancer screening. Millions remain unscreened, losing opportunities to detect the disease while it may still be curable. LEAP is intended to provide early biological information for additional physician assessment, though a negative result does not rule out lung cancer, and an abnormal result recommends further clinical evaluation.
“Our goal is to help more people find lung cancer early, when the opportunity for curative treatment is greatest,” said André de Fusco, CEO and co-founder of Hawkeye Bio. “HealthQuest brings the laboratory expertise, established operations and physician support needed to translate our biosensor technology into a dependable clinical service. Together, we aim to help physicians engage more eligible patients for recommended screening and eliminate tens of thousands of preventable deaths each year.”
HealthQuest Esoterics independently validated LEAP’s clinical performance, demonstrating 95% sensitivity across all lung cancer stages and subtypes. Based on this performance, LEAP has a projected negative predictive value of 99.9% in the intended use population, meaning a negative result is highly likely to correctly indicate the absence of cancer. LEAP is available as a self-pay laboratory-developed test (LDT) and is not currently covered by insurance. It has not been cleared or approved by the FDA.
“We built HealthQuest to give physicians reliable results and responsive service they can count on,” said Tom Giancursio, CEO of HealthQuest Esoterics. “LEAP extends that mission by combining Hawkeye’s proprietary science with our laboratory expertise and established clinical relationships. Our role is to make validated innovations practical to order and deliver through dependable testing, coordinated specimen collection and support for the physicians caring for these patients.”
Paul Dempsey, Chief Science Officer and co-founder of Hawkeye Bio, explained the science: “LEAP measures patterns of protease activity associated with lung cancer, providing a different view of disease biology from tests that measure biomarker quantity alone. Protease enzymes are involved in how cancer interacts with surrounding tissue and the immune system. For the high-risk population evaluated in our studies, we assess sensitivity together with specificity and stage-specific performance. For individuals eligible for screening under USPSTF guidelines, our priority is high sensitivity to minimize the risk of missed cancers.”
Healthcare providers can request ordering instructions, specimen requirements, current self-pay pricing and clinical information by contacting info@hawkeyebio.com or info@hqesoterics.com.
About Hawkeye Bio, Inc.
Hawkeye Bio is a biotechnology company advancing early cancer detection through blood-based testing. Its proprietary graphene biosensor platform measures protease activity—biological signals associated with cancer development—to support the development of tests for earlier disease detection. The company’s first product, LEAP, is designed to complement low-dose CT screening. Hawkeye is also developing applications across additional cancers and women’s health, with a mission to make early detection more accessible and cost-effective. For more information, visit https://www.hawkeyebio.com or contact info@hawkeyebio.com.
About HealthQuest Esoterics, Inc.
HealthQuest Esoterics, Inc. is an established clinical reference laboratory based in Irvine, California, providing diagnostic testing services to healthcare providers, clinics and hospitals. Its testing portfolio spans clinical chemistry, endocrinology, molecular diagnostics and infectious diseases. Operating since 2015, HealthQuest combines experienced scientists and technologists with capabilities in test development and validation, clinical testing, specimen logistics and physician support. For more information, visit www.hqesoterics.com or contact info@hqesoterics.com
Media Contacts:
media@hawkeyebio.com — Hawkeye Bio, Inc.
media@hqesoterics.com — HealthQuest Esoterics, Inc.
References:
(1) American Cancer Society – Key Statistics for Lung Cancer – Jan 13, 2026. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html
(2) American Cancer Society – Latest ACS Lung Cancer Data – November 19, 2025; reporting 2024 National Health Interview Survey results. https://pressroom.cancer.org/2025-lung-cancer-data14-
(3) USPSTF: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening
ANDRE DE FUSCO
Hawkeye Bio, Inc.
Why it matters: By offering a blood test with 95% sensitivity and a projected 99.9% negative predictive value, this collaboration provides physicians with a new tool to engage the millions of at-risk adults who remain unscreened. If adopted widely, it could meaningfully shift lung cancer detection toward earlier, more curable stages.
