Additional positive EarlyCDT-Lung data presented at ERS Congress, Milan

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The National Health Service (NHS) Scotland-sponsored Early Cancer Detection Test – Lung Cancer Scotland (ECLS) study of 12,000 high-risk smokers has demonstrated additional, positive, early detection of lung cancer with the use of the EarlyCDT-Lung test.

The ECLS Study was established to determine if the use of EarlyCDT-Lung leads to earlier detection of lung cancer and can help to save lives in the long term. As part of the study, half of the patients pre-identified as high risk for lung cancer were followed up by usual care and half were asked to take the EarlyCDT-Lung test. Those who received a positive result from the EarlyCDT-Lung test were effectively triaged into a much higher risk group and referred for X-ray or for low dose computerized tomography (CT) scan (base-line, then every 6 months for a total of 24 months). 

Data presented at the ERS Congress in Milan, last week, as an update to the presentation at the IASLC Congress in December 2016, showed the following: this is compared to the December 2016 findings for ease of reference.

November 2016July 2017
Patients randomized12,21012,210
EarlyCDT-Lung Cohort6,0916,089
Positive finding9.8%9.8%
Chest XR completed590583
CT scans completed2,0802,335
Patients with nodules277327
Further valuation (staging)110 (1)
Lung cancer diagnosis1616
Early stage (I & II)1212

This confirms that nodules and tumors are being identified and confirmed as the CXR/CT scans continue to be done (four times in 24 months). The six-month period shows that there was an increase in patients in whom nodules had been found, are being followed up for cancer and are being staged.

The stage shift to finding 75% of cancers early (12/16) is a primary endpoint of the study and compares to a usual 20% of early cancers found with CT.

The December 2016 data demonstrated a sensitivity for EarlyCDT-Lung of 84.2% while maintaining specificity of 90.8%. This contrasts with the validation studies where, with only a single CT scan within six months of a positive finding, sensitivity was 41%.

These results would indicate that these additional patients were not identified at baseline, but have developed during the follow-up period. Only patients with a positive finding are being followed up by CXR or serial CT scans.

The problem with lung cancer screening in the U.S. is that less than 3% of patients will engage in CT screening programs for early detection of lung cancer. Utilization of EarlyCDT-Lung, which is a blood-based test, has a compliance rate of 95% to 98%. The test, which measures a panel of seven autoantibodies to detect the presence of lung cancer, is marketed in the U.S. by Innovative Diagnostic Laboratory, a unit of GeneNews (TSX:GEN).