Policy & Regulation
BiologyWorks k(now) COVID-19 Clinical Trial Matches 99.1% Accuracy to RT-PCR Tests
19 January 2022 - - A clinical trial of US-based digital healthcare platform company BiologyWorks, Inc's handheld, reusable molecular test for COVID-19 matched 99.1% accuracy to laboratory RT-PCR tests, the company said.

The independent clinical trial, conducted by Locus Medicus in Athens, Greece, prospectively tested 330 patients with symptomatic and asymptomatic cases of COVID-19.

For the study, staff at the clinical laboratory collected two bilateral anterior nasal swabs from each patient. Immediately after collection, one swab was tested in the lab's standard of care CE-Mark RT-PCR test and the other swab was tested by BiologyWorks k(now).

Results from the BiologyWorks k(now) molecular test were 99.1% in overall % agreement with the results of the RT-PCR lab tests.

In addition to the clinical trial conducted by Locus Medicus, other independent validation studies of BiologyWorks k(now) have been conducted by the University of California, Los Angeles, the Los Angeles County Department of Health Services and Streeklab in Haarlem, Netherlands.

Moreover, the company verified the efficacy of BiologyWorks k(now) with over 12,000 tests in its Southern California lab.

These studies also validate that the BiologyWorks k(now) molecular COVID-19 test provides RT-PCR lab quality results, the company said.

BiologyWorks' molecular test works in conjunction with the k(now) PRO digital platform, which provides point-of-care providers with a complete solution for end-to-end testing management. POC providers and patients simultaneously receive verified results within 45 minutes, giving individuals control of their health data.

The BiologyWorks k(now) PRO digital platform complies with the privacy standards, including the Health Insurance Portability and Accountability Act (HIPAA) and the EU General Data Protection Regulation.

BiologyWorks is the creator of BiologyWorks k(now) molecular test and the k(now) PRO digital platform.

Together, these products offer point-of-care providers with a solution for testing management.

The company's chemistry is patent-protected, based on research originating with the Alfred Mann Foundation, and is underwritten by a grant from the Bill and Melinda Gates Foundation.