Already launched in India for TB, the clinical trial showed Genedrive was 100% accurate in detecting inherited genetic polymorphisms in Hepatitis (HCV) patients compared to the current ‘gold-standard’ laboratory test, Roche’s TaqMan PCR.
Epistem said Genedrive also produced results in 50 minutes from a simple cheek swab compared to the standard blood sample test that can take 2-3 weeks.
David Budd, Epistem’s chief executive, said the trial was excellent external validation of Genedrive both as a diagnostic system and as a technology platform in the rapidly growing field of pharmacogenomics.
“As medicine becomes more personalised, there is an increasing need to detect genetic differences in patients.
“We have efficiently demonstrated Genedrive’s ability to undertake rapid genotyping in a simple manner.”
The results should allow it to work with pharma groups to develop companion diagnostic tests, he added.
The study comprised 246 HCV patients of different stages and genotypes.
Dr Stanislas Pol, the lead clinical investigator of the study at the Institut Pasteur, said: “This study shows that genetic testing is feasible in a point of care context.
“The study opens the door for development of additional tests, including the rapid qualitative detection of HCV RNA, which is our next priority for the screening of HCV infection and the monitoring of therapeutic intervention.”
