Ellume recalls 200,000 Covid-19 test kits over false positives
06 Oct 2021
Australian medtech Ellume has recalled nearly 200,000 Covid-19 test kits in the US due to concerns about false positive results.
https://www.medicaldevice-network.com/news/ellume-recall/
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What's needed is next gen QMC Quantum Dot Covid Tests which are extremely sensitive and more accurate. From the 8-25 Shareholder Letter -
DOT-IQ, point of care testing technology
The Company recognized early in the advent of Covid-19 that we could use our proprietary technologies to design and develop a more sensitive lateral fl ow test kit using our unique quantum dot technologies. Over the past several months, we have expanded our biotech team and collaborated with our material scientists. As a result,we have now developed a point of care test platform (POCT) that we believe is more sensitive than current technologies. We believe it will provide analytic sensitivity that can rival PCR and provide quantitative results when warranted. We are currently developing 1) LFTs (lateral flow test kits) for TBI (traumatic brain injury, aka concussions), 2) multiplex test that detects Covid-19, Flu and RSV (Respiratory Syncytial Virus) , and 3) a vaccine validator to thwart counterfeit vaccines and validate vaccine efficacy. This test kit technology uses a unique quantum dot as a signal amplifier and can give a visual test result indication using a low-cost UV light source or using our POCT reader to interface with a P.C. or a smartphone. This reader is designed to provide a binary readout indicating positive or negative and quantitative result indicating the level of viral loading. We believe that this can be very valuable, particularly in viruses like Covid-19, where a current test cannot reliably identify low viral loading, which is often the case in asymptomatic individuals who are the most likely to spread the virus unknowingly. In addition, the Company has signed a term sheet with a Canada-based biotech company that has identified and has a patent-pending on several biomarker candidates that will be used to develop the TBI POCT. The term sheet is non-binding and we can provide no assurance that we will be able to reach definitive agreements on terms acceptable to the Company. We are in the process of negotiating the final terms that include the payment milestones required for QMC to design, develop, shepherd the FDA approval process, and produce the test kits.
We believe the POCT market is poised for significant growth and the need for rapid, low-cost, highly sensitive, and quantitative point of care tests can best be meet with quantum dot enabled technologies. We Intend to continue the expansion of our biotech staff and capabilities,provided we are able to generate sufficient cash flows from operations or through additional financing. This technology is intended to part of our immediate commercialization focus.
06 Oct 2021
Australian medtech Ellume has recalled nearly 200,000 Covid-19 test kits in the US due to concerns about false positive results.
https://www.medicaldevice-network.com/news/ellume-recall/
--
What's needed is next gen QMC Quantum Dot Covid Tests which are extremely sensitive and more accurate. From the 8-25 Shareholder Letter -
DOT-IQ, point of care testing technology
The Company recognized early in the advent of Covid-19 that we could use our proprietary technologies to design and develop a more sensitive lateral fl ow test kit using our unique quantum dot technologies. Over the past several months, we have expanded our biotech team and collaborated with our material scientists. As a result,we have now developed a point of care test platform (POCT) that we believe is more sensitive than current technologies. We believe it will provide analytic sensitivity that can rival PCR and provide quantitative results when warranted. We are currently developing 1) LFTs (lateral flow test kits) for TBI (traumatic brain injury, aka concussions), 2) multiplex test that detects Covid-19, Flu and RSV (Respiratory Syncytial Virus) , and 3) a vaccine validator to thwart counterfeit vaccines and validate vaccine efficacy. This test kit technology uses a unique quantum dot as a signal amplifier and can give a visual test result indication using a low-cost UV light source or using our POCT reader to interface with a P.C. or a smartphone. This reader is designed to provide a binary readout indicating positive or negative and quantitative result indicating the level of viral loading. We believe that this can be very valuable, particularly in viruses like Covid-19, where a current test cannot reliably identify low viral loading, which is often the case in asymptomatic individuals who are the most likely to spread the virus unknowingly. In addition, the Company has signed a term sheet with a Canada-based biotech company that has identified and has a patent-pending on several biomarker candidates that will be used to develop the TBI POCT. The term sheet is non-binding and we can provide no assurance that we will be able to reach definitive agreements on terms acceptable to the Company. We are in the process of negotiating the final terms that include the payment milestones required for QMC to design, develop, shepherd the FDA approval process, and produce the test kits.
We believe the POCT market is poised for significant growth and the need for rapid, low-cost, highly sensitive, and quantitative point of care tests can best be meet with quantum dot enabled technologies. We Intend to continue the expansion of our biotech staff and capabilities,provided we are able to generate sufficient cash flows from operations or through additional financing. This technology is intended to part of our immediate commercialization focus.
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