Molecular diagnostics company Genedrive has partnered with Cytiva, formerly called GE Healthcare Life Sciences, for the development of an assay to detect SARS-CoV-2, which causes Covid-19.
The new test, called Genedrive 96 SARS-CoV-2 assay, is being developed for use on polymerase chain reaction (PCR) instruments in laboratories.
Designed as a one-step, ready-to-go freeze-dried assay, the test leverages Genedrive’s PCR chemistry along with Cytiva’s LyoStable stabilisation technology.
The combination is expected to facilitate high-throughput manufacturing of more than 10,000 tests per hour with a 96-well, temperature-stable plate format that does not require refrigeration.
Genedrive 96 SARS-CoV-2 assay consists of a single PCR bead that can be mixed with a patient’s sample, allowing the test to be performed on existing open PCR platforms, including those from Roche and ABI (Thermo Fisher).
Genedrive CEO David Budd said: “We have extensive experience working with the Cytiva team on assay development and manufacturing for our point-of-care HCV, AIHL and military programmes.
“We are pleased to now apply that partnership in a high-throughput manufacturing process, which we believe places us amongst a small group of companies that have the capability to produce simple assay solutions at significant scale.”
The partners aim to make the assay available in the next five weeks. In alliance with Cytiva, Genedrive hopes to deliver a consistent and reproducible assay that can be manufactured in high volume.
Cytiva Genomics and Diagnostics general manager Gabriel Fernandez de Pierola said: “Critical to overcoming the pandemic is being able to produce high volumes of reliable tests, which can be shipped easily on a global basis with minimal environmental impact.
“We hope our Lyo-Stable technology coupled with Genedrive’s high-throughput testing solution will help deliver technical solutions to address the current crisis.”
Genedrive is also working to develop a second point-of-care SARS-CoV-2 test that will use its formulations to run on the Genedrive instrument platform.