Features: Specifically suited for blood specimen characterization; Pre-dispensed, suitable for a wide range of common models; High sensitivity up to 0.2%; Full EGFR assay covers most mutation types; One-step loading, 120-minute results.

Applicable samples: whole blood or plasma

In recent years, it has become standard clinical practice to use the results of EGFR gene mutation testing to guide the treatment of EGFR-TKIs in patients with non-small cell lung cancer (NSCLC), and EGFR-TKIs have become the first-line standard of care for patients with advanced NSCLC with mutations in the EGFR gene, and the third-generation TKIs can also be used to target the second-line of patients who have progressed due to the emergence of T790M mutations after the first- or second-generation TKI administration and later treated patients. However, for patients with advanced NSCLC, tissue specimens are not easy to obtain and are limited in number, and some patients are unable to undergo molecular testing due to insufficient or inaccessible tissue specimens, and less than 50% of NSCLC patients who have progressed on EGFR-TKI therapy are eligible for tissue re-biopsy.

Blood specimens are noninvasive and reproducibly sampled, and several retrospective and prospective studies have demonstrated that positive results from circulating free or tumor DNA (cf/ctDNA) assays can be used as a confirmatory basis for the administration of EGFR-TKIs. Therefore, the use of blood specimens for EGFR gene testing can help patients effectively save limited tissue specimens and realize the greater benefits of precision diagnosis and treatment. China's State Food and Drug Administration (CFDA) also successively approved the addition of gefitinib for EGFR mutation-positive patients assessed by blood specimens in 2015; and approved the third-generation EGFR-TKI ositinib for the treatment of EGFR T790M mutation-positive patients clarified by tissue or plasma samples in 2017. Blood EGFR gene testing has become an urgent need in the clinical management of NSCLC.