genedrive has submitted an application seeking approval to sell its rapid molecular test, Genedrive COV19-ID Kit in the UK under the new Coronavirus Test Device Approvals (CTDA) regulations.
The latest move follows the receipt of CE-IVD certification for the point-of-care assay earlier this month.
The regulations, which became effective on 1 November this year, have placed specific registration, review, and performance requirements on Covid-19 diagnostic products suppliers in the UK.
For the CTDA approval, the Thermo Fisher’s TaqPath COVID-19 RT-PCR test was used to compare the extended clinical validation sample cohort.
The company stated that its COV19-ID assay was found to have 98% specificity and sensitivity in 264 samples with viral load >500 copies per ml.
The rapid molecular test has also met the current requirements from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for point-of-care SARS-CoV-2 molecular tests, along with successful detection of the Omicron variant.
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genedrive CEO David Budd said: “CTDA performance data builds on the data already generated for CE certification and demonstrates that the product meets the expanded UK requirements for Point-of-Care Covid-19 molecular tests.
“The next milestone is approval by the Department of Health and Social Care, however, no assured timeline is provided on how long the review under CTDA regulations will take, given a current backlog in their reviews.
“We have confidence in our data and the application is another positive step that allows us now to progress UK focused commercial discussions.”
The Genedrive COV19-ID kit uses reverse-transcription loop mediated isothermal amplification (RT-LAMP) and a buffer formulation for obtaining quick results without viral extraction steps.
It is designed to detect SARS-CoV-2 virus using a nasal mid-turbinate swab. The assay provides positive results in seven and a half minutes while negative results in 17 minutes.
The rapid molecular diagnostic test targets the SARS-CoV-2 genome’s ORF1ab and N genes.