TEST:

OncoBEAM EGFR v2 Kit

Plasma-SeqSensei™ Solid Cancer IVD Kit resulted in de novo detection of targetable oncogenic drivers and resistance mechanisms in patients with NSCLC, including when tissue biopsies were inadequate for genotyping with high sensitivity and accuracy for low and high cfDNA inputs.

"The Plasma-SeqSensei™ SOLID CANCER IVD kit resulted in de novo detection of targetable oncogenic drivers and resistance alterations, with a high sensitivity and accuracy for low and high cfDNA inputs. Thus, this assay is a sensitive, robust, and accurate test."

The median mutant allele frequency (MAF) for all mutations detected by OncoBEAM was 0.50% (range: 0.04–50.84%), where 64% and 23% of mutations were detected with MAF <1% and <0.1%, respectively. Concordance of results between OncoBEAM and SafeSEQ in 176 replicate samples revealed an overall percent agreement of 99.6% with strong linear correlation of MAF (R2 = 0.98).Conclusions OncoBEAM LB enables sensitive and accurate genotyping results within 5 days, ∼3x faster than the TAT of tissue genotyping results, which carries significant implications for enabling rapid implementation of targeted therapies for NSCLC patients