Hawkeye Bio and HealthQuest launch LEAP blood test for lung cancer screening support
Hawkeye Bio and HealthQuest Esoterics said Oct. 26 that LEAP, a prescription blood test designed to support early lung cancer detection, is now commercially available through HealthQuest. The test is meant to complement low-dose CT screening and is being offered as a self-pay laboratory-developed test with results available within seven days of sample receipt.
Why it matters: - Lung cancer is the leading cause of cancer death in the U.S., and the companies say millions of eligible adults are still not up to date on screening. - LEAP is intended to add early biological information before a physician review, which could help close screening gaps and support earlier treatment decisions. - HealthQuest says the validated test is now practical to order and deliver through its clinical operations and specimen network.
What happened: - Hawkeye Bio and HealthQuest Esoterics announced the commercial availability of LEAP through HealthQuest on Oct. 26, 2026. - LEAP is a prescription blood test designed to support early lung cancer detection and complement low-dose CT screening. - The test uses Hawkeye’s proprietary graphene biosensor technology to measure patterns of protease enzyme activity associated with lung cancer. - Testing is performed at HealthQuest’s CLIA-certified laboratory in Irvine, California. - Results are available within seven days of sample receipt.
The details: - Hawkeye Bio contributes biosensor research and assay-development capabilities. - HealthQuest provides laboratory validation expertise, physician relationships, specimen-collection infrastructure and clinical testing operations. - HealthQuest independently validated LEAP clinical performance during the formal analytic validation of the commercial test. - The validation study showed 95% sensitivity across all lung cancer stages and subtypes. - LEAP has a projected negative predictive value of 99.9% in the intended-use population. - A negative LEAP result does not rule out lung cancer. - An abnormal result calls for further clinical evaluation. - LEAP is available as a self-pay laboratory-developed test. - LEAP is not currently covered by insurance. - LEAP has not been cleared or approved by the FDA. - Healthcare providers can request ordering instructions, specimen requirements, current self-pay pricing and clinical information by contacting info@hawkeyebio.com or info@hqesoterics.com. - Hawkeye Bio’s website is the company’s site. - HealthQuest’s website is the laboratory’s site.
Between the lines: - The partnership gives Hawkeye Bio a route from research to clinical use, while HealthQuest gains a new test built around proprietary biosensor science. - Hawkeye Bio and HealthQuest frame the collaboration as a platform for additional diagnostic applications as they are developed and validated. - Hawkeye Bio says LEAP measures protease activity, which provides a different view of disease biology than tests that measure biomarker quantity alone. - The company says protease enzymes are involved in how cancer interacts with surrounding tissue and the immune system. - For the high-risk population studied, the company says it is prioritizing sensitivity and stage-specific performance.
What’s next: - HealthQuest and Hawkeye Bio plan to use the collaboration as a foundation for bringing more diagnostic applications into clinical use. - Physicians can now begin requesting ordering details and pricing for LEAP. - The test’s broader market adoption will likely depend on physician uptake, patient willingness to self-pay and future coverage decisions.
The bottom line: - LEAP enters the market as a non-FDA-cleared, self-pay blood test aimed at improving early lung cancer detection alongside standard CT screening.
Disclaimer: This article was produced by AGP Wire with the assistance of artificial intelligence based on original source content and has been refined to improve clarity, structure, and readability. This content is provided on an “as is” basis. While care has been taken in its preparation, it may contain inaccuracies or omissions, and readers should consult the original source and independently verify key information where appropriate. This content is for informational purposes only and does not constitute legal, financial, investment, or other professional advice.
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