RE: AIHL test in Europe and WHO's next?......13 Jul 2021 10:46
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NEW YORK — Even as it has its eye on launching a test for SARS-CoV-2, Genedrive is circling back to its legacy business.
Genedrive aims to have a point-of-care molecular test for SARS-CoV-2 on the European clinical market within the next few months, according to its CEO David Budd. And while the COVID-19 pandemic has drawn its attention, as it has done for most firms in the molecular diagnostics space, Genedrive is renewing its focus on other tests in its menu, he added.
The Manchester, UK-based company had previously planned to have a CE-IVD marked point-of-care SARS-CoV-2 test out by June 30, but informed shareholders earlier this month that it would miss that deadline, citing a "longer than anticipated development time."
"Since we missed the deadline, we had to update the market on our progress," Budd remarked. "It was a line we had previously drawn in the sand."
In its statement, Genedrive noted "significant technical hurdles" in the test's development, as well as its desire to improve the performance specifications of the platform, as the requirements of the SARS-CoV-2 testing market have been evolving, especially related to sensitivity, specificity, speed, ease of use, and scalability.
"In developing these things, half of it is biological, so it's not like building a house where you can buy some timber, screws, and assemble it," commented Budd. "Stuff happens that you don't always have control over, but we managed to do away with a lot of the uncertainty upfront," he said. Budd also noted that there have been scientific advances related to direct PCR that have allowed the company to improve its workflow as it prepares the product for a CE-IVD mark.
Genedrive's test relies on a nasopharyngeal swab as a sample source, and Budd said that Genedrive developed a proprietary lysis buffer to deliver biosafety to the product both before and after the swab is used. Public Health England is currently assessing the biosafety of the method.
The firm's handheld eponymous instrument includes a PCR thermocycling device that provides rapid nucleic acid amplification and detection results and allows users to detect SARS-CoV-2-positive samples in about 10 minutes, with negatives reported after 20 minutes if no signal is detected. The system fits in a user's palm, is 12 cm by 18 cm by 10 cm, and weighs 600 grams, Budd said. The list price for the system is less than $3,000 and normally offered as part of a reagent rental package, he added.
The test targets two genes in the SARS-CoV-2 genome, and is inclusive of all variants of concern, including the delta variant. An internal validation study found 100 percent concordance with 30 positive and 30 negative samples tested originally with real-time PCR.
The four-step workflow relies on an eye dropper liquid transfer process so that non-technicians can run the test. The company is currently targeting a late September or early October date fo
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