Test detecting COVID-19 within 20 seconds undergoes MHRA registration

SpectraLIT, a pathogens diagnostic device able to test for SARS-CoV-2 within 20 seconds, is undergoing MHRA registration and, with approval expected imminently, will soon be available in the UK.

The device uses mass spectrometry to generate high resolution spectral signatures of a sample’s contents. These signatures are interpreted using artificial intelligence as either positive or negative for SAR-Cov-2, the virus that causes COVID-19. Samples can be collected using either a nasopharyngeal swab or non-invasive mouthwash solution.

Adrian Stevens, CEO, Inventive Health said: “SpectraLIT moves the science of physics into medicine. By making point-of-care testing for COVID-19 simple and quick, SpectraLIT can help protect the community as we return to open-border travel, enable sports venues to operate at full capacity, ensure care homes can safely welcome visitors, permit the reopening of nightclubs and reopen schools and universities to face to face learning.

“PCR testing undeniably remains the gold standard but scaling laboratory testing is also troublesome and costly. Likewise, the time needed to perform and receive a result from a lateral flow test renders them impractical for larger groups. Whatever the venue, the ability to receive a highly reliable result in near real-time means SpectraLIT helps open the door to safely resuming normal day-to-day activities.”

Delivered by health technology company, Inventive Health, SpectraLIT was developed by Virusight Diagnostic - a joint venture between two of Israeli institutions; Newsight Imaging and Sheba Medical Center.

The MHRA approval process is being driven by Inventive Health and is currently focussed on the nasopharyngeal swab with the mouthwash alternative following soon.

Inventive Health is working closely with government authorities and healthcare clinicians across the globe. As well as the UK, collaborations and trials using SpectraLIT are underway in over 30 countries including Malta, Poland, and Slovakia, across Africa, India, France, Gibraltar, and Mexico with other countries soon to be confirmed.

SpectraLIT has already been awarded CE certification by the Obelis European Authorized Representative Center for use across EEA Member States and is currently undergoing FDA approvals in the United States.

Early clinical performance reports from the Baylor Scott & White Research Institute as part of the FDA approval process in the United States indicate SpectraLIT is at least 82% accurate in identifying symptomatic cases. However, it is noted that the accuracy is likely higher as the tests included samples over three days old and, as with all technology driven by Artificial Intelligence and Machine Learning, accuracy improves with usage.

Inventive Health’s leadership team includes medical experts, business leaders and AI specialists with experience and a track record of building international healthcare organisations.

Dr. David Dembo, Inventive Health’s chief medical officer, said: “Although vaccination programmes are thankfully proving successful in lowering the risk of severe disease, there will be a continuing need for ultra-rapid testing to prevent transmission and further outbreaks of COVID-19. All pathogens such as SARS-CoV-2 have a unique high resolution digital signature that can be detected using spectral analysis. With every sample taken, the AI and machine learning supporting SpectraLIT improves its detection of COVID-19.

“While COVID-19 will remain a constant in our lives for the foreseeable future, SpectraLIT can also be easily adapted to detect other pathogens including Influenza, HIV, Ebola, MERS, and tropical viruses, such as Zika and Malaria, as well as bacterial disease. This will also be important for the testing and trials of new vaccines for viruses and variations as drug resistance strains emerge.”

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