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We’ve spoken before about the urgent need for early detection in lung cancer. So why do we believe our LungLB test is an answer? There are three reasons that give us confidence.
First, are the results from our pilot validation study. We demonstrated a balanced test with strong sensitivity and specificity, and a high PPV of 89%. To put that in context, any time the LungLB test is positive, that means there's an 89% chance that individual has lung cancer. Compare that to the standard of care right now at around 60% PPV. We were also delighted to have it peer-reviewed and published in BMC Pulmonary Medicine in June 2023. [1]
Second, the results from our multi-site clinical validation study concluded in January of this year. This showed an 80% positive predictive value in cases of indeterminate nodules less than 15 mm in diameter found by CT scan. We were particularly pleased this re-enforced the findings in our pilot study.
We know from our conversations with clinician’s small lung nodules present the most challenging to diagnose and represent the greatest unmet need and where currently available tools fall short.
And lastly, LungLB is easy to use. All we require is a simple blood draw sent to our CLIA and CAP certified lab in California; and we do the rest.
As a precursor to our full commercial launch later this year, we have launched our Early Access Program. If you would like to participate, please click the Order LungLB Test button below.
Tahvilian S, Kuban JD, Yankelevitz DF, et al. The presence of circulating genetically abnormal cells in blood predicts risk of lung cancer in individuals with indeterminate pulmonary nodules. BMC Pulmonary Medicine. 2023;23(1):193.