TEST:

UltraSEEK® Lung Panel

Of the three variants not detected by UltraSEEK®, two were not included in the panel and one was included but not detected. Of the seven variants found in tissue, five could also be detected in the matching saliva samples (71%), either by utilizing ClearSEEK™ or UltraSEEK® The detection of PIK3CA hotspot mutations in OSCC and their simultaneous occurrence in saliva underline the potential benefit of liquid biopsies for non-invasive cancer detection and follow-up care of OSCC patients.

The evaluation of the nRichDX Revolution Sample Prep System on the MassARRAY System has demonstrated its effectiveness in achieving 0.1% VAF detection in plasma and urine samples. The nRichDX System extracts cfDNA and ctDNA with consistently high yields. Two sample T-Test analysis shows that the nRichDX System performed significantly better than the QIAGEN and Thermo Fisher Scientific extraction kits.

P=N/A; CTCs and high PD-L1 sEV concentration correlated with PFS and OS, but not ctDNA mutations. Their combined analysis may help to identify patients with worse OS.

The use of molecular tumor profiling with ctDNA and the UltraSEEK Lung Panel identified therapeutically relevant mutations at a comparable rate as tumor tissue NGS. Therefore, this approach might serve as a pre-screening tool for identifying actionable variants in the absence of tumor tissue, or as a complementary test alongside tumor tissue NGS.

A decrease in ctDNA levels at 4-6 weeks after treatment initiation detected with UltraSEEK correlated with prolonged median PFS (46 vs. 6 weeks; p < 0.05) and OS (145 vs. 30 weeks; p < 0.01). Using plasma-derived ccfDNA, the UltraSEEK Lung Panel with a mid-density set of the most common predictive markers for NSCLC is an alternative tool to detect mutations both at diagnosis and during disease progression and to monitor treatment response.

Molecular tumor profiling using ctDNA with the UltraSEEK Lung Panel identified therapeutically relevant mutations at a rate comparable to tumor tissue NGS, and might therefore serve as a prescreening tool for baseline actionable variant identification in the absence of tumor tissue, or as a complementary test in addition to tumor tissue NGS.

Two sample T-Test analysis shows that nRichDX, at all levels, performed significantly better than Qiagen at p < 0.05. The results demonstrate the capability of the nRichDX system to recover more amplifiable copies with consistent cfDNA quality and ctDNA frequency and hence offer the opportunity to increase the sensitivity of detecting lower frequency mutations in cfDNA and a wider variety of biomarkers.

Combining CTC cluster counts and cfDNA levels could improve PFS assessment in NSCLC patients. Our results encourage further investigation on the combined effect of CTC/cfDNA as a prognostic biomarker in a large cohort of advanced stage NSCLC patients.

The results suggest that EBC is effective in identifying clinically relevant alterations in patients with lung cancer using UltraSEEK™ and has a potential role as an adjunct to plasma testing.

Using plasma-derived ccfDNA, the UltraSEEK® Lung Panel with a mid-density set of the most common predictive markers for NSCLC is an alternative tool to detect both mutations at diagnosis and disease progression, and to monitor treatment response.