The performance of ADPS™ has been acknowledged through several clinical trials.
The below data is clinical performance evaluation data of the ADPS™ EGFR Mutation Test kit compared to previously approved products at Seoul Asan Medical Center in November, 2019.
40 participants who had been diagnosed with NSCLC (Adenocarcinoma or squamous cell carcinoma) took part. Prior to the clinical trial, the 40 participants were confirmed as positive or negative for EGFR T790M and C797S through tissue biopsy. (The samples in this test were provided by the patients voluntarily with written consent.)
|Input copies/rxn||Detected copies||MAF(%)||ADPS™||'R' Company||Amplicon based NGS evalutation|
|PPA (Positive percent agreement)||100.0%||13/13x100|
|NPA (Negative percent agreement)||85.2%||23/27x100|
|OPA (Overall percent agreement)||90.0%||(13+23)/40x100|
|T790M(Plasma)||'R' Company + NGS||Total|
|PPA (Positive percent agreement)||100.0%||17/17x100|
|NPA (Negative percent agreement)||100.0%||23/23x100|
|OPA (Overall percent agreement)||100.0%||(17+23)/40x100|
GENECAST conducted comparison experiment between ADPS™ EGFR Mutation Test Kit v1 and EGFR Mutation Test kit of company R in Asan medical center, a one of the biggest hospital in korea.
After the experiment, NGS was selected for verification.
As a result, ADPS™ EGFR Mutation Test Kit v1 got coincide result as NGS while EGFR Mutation Test kit of company R showed 4 false negative.