Clinical Validation
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Clinical validation
study results

Percepta GSC clinical validation study design and results

Percepta GSC was validated in a prospective, multicenter, blinded study on a combined cohort of 412 patients from AEGIS I, AEGIS II and PERCEPTA Registry.1

Percepta GSC stratifies the risk of primary lung cancer across all pre-test risk groups to guide patient management when bronchoscopy is inconclusive.

Flowchart showing Percepta’s reclassification of risk. Pre-test, 28% of results are classified as “intermediate.” Post-test, those are reclassified into low risk with 91% NPV or high risk with 65% NPV. Low and high pre-test risk may also be reclassified into very low and very high post-test risk respectively. When a pre-test risk is down-classified to low, additional invasive procedures may be avoided. When pre-risk test is up-classified to high, this informs next intervention steps.

For intermediate pre-test risk patients, Percepta GSC can down-classify or up-classify.

For intermediate pre-test risk patients with an inconclusive bronchoscopy, Percepta GSC can down-classify the risk of primary lung cancer to low with a 91% NPV to help avoid additional invasive procedures or up-classify the risk to high with a 65% PPV to inform next intervention steps.2

Pivotal validation study
Green triangle pointing down: down-classify the risk to low with a 97% NPV to help avoid additional invasive procedures. Red triangle pointing up: up-classify the risk to high with a 65% ppv to inform next intervention steps.

Percepta GSC improves the sensitivity of bronchoscopy regardless of nodule size, location, and cancer type.3

Bar charts showing increase in sensitivity of bronchoscopy when the Percepta GSC test is added. Regardless of nodule size, location, and cancer type, the sensitivity is consistently increased to about 90%.
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Percepta GSC detects genomic changes to determine if a nodule is cancerous without the need to directly sample the nodule.

Using whole-transcriptome RNA sequencing technology Percepta GSC is clinically validated with a combined cohort from AEGIS I and II & PERCEPTA Registry. 

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References

1. Choi Y, et al. BMC Medical Genomics, 2020.
2. Mazzone P, et al. Oral Presentation CHEST Annual Meeting 2019.
3. Dotson T, et al. Virtual e-poster, ATS Annual Meeting 2020.