Digital healthcare platform firm BiologyWorks has announced that its k(now) handheld molecular testing device showed 99.1% accuracy with RT-PCR lab test results in a substantive Covid-19 clinical trial.
Conducted by Locus Medicus in Athens, Greece, the independent clinical study tested 330 asymptomatic and symptomatic Covid-19 patients.
The clinical laboratory staff collected two bilateral anterior nasal swabs from each patient for the trial.
One swab was tested in the handheld, reusable molecular test while the standard of care CE-Mark RT-PCR lab test was used for the other.
Findings showed that the molecular testing device was 99.1% accurate with the laboratory RT-PCR test results.
BiologyWorks k(now) molecular Covid-19 test is connected with the k(now) PRO digital platform, which provides a complete solution to point-of-care (POC) providers for end-to-end testing management.
The device provides results to patients and POC providers simultaneously in 45 minutes.
The company stated that the Los Angeles County Department of Health Services, the University of California Los Angeles (UCLA) and Streeklab in Haarlem, Netherlands, have also conducted independent studies on the BiologyWorks k(now).
Additionally, the molecular testing device’s efficacy was verified with more than 12,000 tests in the company’s Southern California laboratory.
All these studies confirmed that the device provides laboratory RT-PCR quality results.
BiologyWorks CEO Hunt Ramsbottom said: “Our company’s priority is to make lab-quality testing accessible, accurate and affordable for everyone.
“These clinical trials confirm that our handheld, reusable test is among the most accurate for Covid-19.
“We give individuals and providers a highly reliable testing platform, with significantly lower cost per result and shortened time to results.”