20th April 2020 Author: Paul Carton
First Disposable Instrument-Free Molecular COVID-19 Test Near Release Date
Under current strict guidelines issued by the Centre of Disease Control and Prevention (CDC) and the World Health Organization (WHO), clinicians must only use the result of a molecular test gives when diagnosing a patient for COVID-19.
And so, the manufacture of qPCR kits has been the sole focus of many companies. However, a consequence of this is that it leads to a worldwide shortage of reagents, leaving countries trying to outbid one another for limited resources.
Because of this, there has been a surge in qPCR kits coming onto the market that use fewer reagents, some adapted for the outbreak and are now presented point-of-care PCR tests. These are small devices, (about the size of a printer) that take cartridges, pre-loaded with primers and probes to detect SARS-CoV-2. These kits usually require an RNA extraction step before the sample can be loaded into the cartridge, which requires extra reagents, which now are in short supply.
To combat all of these problems, and adhere to WHO and CDC guidelines, Sense Biodedection is developing the Veros™ SARS-CoV-2 test, the first disposable nucleic acid test for COVID-19. This fully self-contained test is about the size of a pregnancy test and performs analysis directly from the swab sample; providing a result in ten minutes.
The test uses isothermal amplification instead of fluorescence-detecting thermocyclers to amplify specific nucleic acid sequences, giving the rapid sample-to-result turnaround.
Sense have started an accelerator programme to fast-track its launch and are working with Phillips-Medsize; a Molex company and a global medical device manufacturer, to scale-up production.
Details on the specificity and sensitivity have not been released yet. However, Sense CEO Harry Lambe has announced the cost will be similar to current PCR tests.
Sense intend to seek an FDA-EUA, a WHO Prequalification listing and CE-marking for the Veros SARS-CoV-2 test.
Date Published: 20th April 2020