LEAP Lung Cancer Test
A Simple Blood Test for the Early Detection of Lung Cancer
LEAP is a decision-support test that helps physicians assess lung cancer risk in asymptomatic patients with risk factors such as age, smoking history, and other exposures. By providing specialized clinical insights, LEAP helps determine the likelihood of detecting lung cancer through chest CT screening, allowing for earlier identification of potential cases and guiding next steps in screening and diagnosis.
Who is LEAP For?
The LEAP test is recommended for individuals considered to be at higher risk for lung cancer according to the American Cancer Society and the U.S. Preventive Services Task Force (USPSTF) screening guidelines:
Current and Former Smokers
Individuals aged 50-80 with a history of 20 pack-years of tobacco use who may otherwise be overlooked in routine health exams.People with Environmental Exposures
Individuals regularly exposed to secondhand smoke, workplace carcinogens, radon emissions, or environmental pollutants (e.g., PM2.5) or deemed high-risk for lung cancer by their doctor.Those Concerned About Radiation Exposure
Patients delaying lung cancer screening due to concerns about the risks associated with radiation exposure, or the cumulative risks of repeated scans over time.
How to Order
1.
Patients consult with their healthcare provider to assess if LEAP is appropriate for them.
2.
A LEAP blood sample is collected at the healthcare provider’s office or via as Ease Healthcare partner.
3.
The ordering physician receives results within within a few days of sample receipt at the lab.
More Information About LEAP
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The LEAP (Lung Enzyme Activity Profile) test measures specific enzymes in the blood to identify patients whose enzyme patterns resemble those seen in individuals with lung cancer. An Abnormal LEAP result indicates that the patient may benefit from a standard-of-care chest scan.
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The LEAP test was developed for individuals with an elevated risk for lung cancer, specifically current or former smokers, 50-80 years of age with 20 pack-years of tobacco use as described by the US Preventive Services Task Force (USPSTF) screening guidelines.
Physicians may also consider individuals with a family history of lung cancer or elevated risk due to environmental exposure and other risk-factors. LEAP can serve as a decision aid for individuals putting off lung cancer screening due to concerns about radiation exposure and the need for repeat scans over time.
The referring physician should judge a patient’s risk in light of clinical factors following conversations with the patient. LEAP is not for those already diagnosed with lung cancer or currently undergoing treatment for lung cancer.
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Yes. While LEAP is best used for patients meeting the USPSTF’s high-risk criteria, it can be ordered for those outside these criteria at the referring physician’s discretion. LEAP has been validated for use with asymptomatic individuals meeting the age requirements set by USPSTF for lung cancer screening. For individuals outside this definition, results are best interpreted in the context of additional clinical risk factors considered by the referring physician.
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LEAP is not a replacement for LDCT but serves as a valuable tool in the screening process, helping physicians identify patients who may need additional imaging or monitoring.
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An “Abnormal” result refers to a blood enzyme profile similar to that seen in patients who have confirmed lung cancer. “Normal” indicates the test returned an enzyme profile that looks like someone who does not have lung cancer. An “Invalid” result is returned when there is a need for retesting due to issues with sample collection or handling.
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No, currently the LEAP test is available as a self-pay test only.
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LEAP performs with a Negative Predictive Value (NPV) of 99.8% in a screening population.
Additional Product Information & Resources
