Iceni Diagnostics has appointed BBI Solutions to produce clinical trial batches for their new, rapid SARS-COV-2/Influenza virus detection test. The test exploits the diagnostic company’s unique, proprietary HPGR™ (Host-Pathogen Glycan Recognition) technology to detect the presence of live virus in non-invasive samples within 15 minutes.
The agreement between Iceni Diagnostics and BBI will transfer protocols to standard lateral flow equipment. This work will enable the generation of devices for clinical trials, with the expectation of moving to assay scale-up and manufacturing transfer.
BBI is an ISO 13485 accredited manufacturer and will work with Iceni Diagnostics to deliver the necessary information required for CE marking of the final product. In parallel, similar studies will be undertaken in the US through a comparable program with a US manufacturer.
Professor Rob Field, CEO of Iceni Diagnostics said: “We are delighted to be working with BBI on our rapid SARS-COV-2/Influenza diagnostic. BBI has a clear understanding of our unique HPGR™ technology, and we are confident they can help us meet our ambitious targets to get product to market as quickly as possible.
“We are excited about the potential of this test. Our proprietary technology identifies intact virus, unlike most existing tests that identify viral genetic material. This crucial difference means that a positive result is a key indicator that live, active virus is present, giving a clear signal of current infection, whether the patient has started to show symptoms or not. Significantly, the test may also identify asymptomatic carriers and thus limit virus spread. It will similarly give rapid clearance to those who need to return home or to their school or workplace but who may still be carrying inactive virus particles following infection.
“We are manufacturing a duplex test that differentiates between SARS-COV-2 and Influenza from one sample. Covid-19 and human flu have similar symptoms so our test will be vital in supporting lockdown decisions during the winter flu season.
“The test is housed in a lateral flow device, with results available within 15 minutes. This makes it ideal to use as a rapid triage option to complement laboratory testing.
“Much interest is being generated worldwide and Iceni Diagnostics is heavily involved in generating the required investment to rapidly accelerate validation, manufacture and distribution to the global market.”
Dr. Mario Gualano, Chief Executive of BBI Group, said “BBI is delighted to extend our lateral flow development expertise to assist Iceni in translating their HPGR™ technology to market readiness for SARS-Cov2 and Influenza testing.
With BBI’s extensive experience in the In Vitro Diagnostics arena, we are confident that the Iceni Diagnostics technology offers significant potential benefits in pathogen detection while maintaining compatibility with an established, scalable, and trusted lateral flow diagnostic platform.
We look forward to working together in further addressing the global challenges presented by COVID-19.”