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May 6, 2020

Coronavirus company news summary – FDA grants EUA to VitalConnect’s cardiac monitoring technology – Applied DNA Sciences applies for FDA’s EUA for its Covid-19 diagnostic test

By Chloe Kent

VitalConnect has announced that US Food and Drug Administration (FDA) has given Emergency Use Authorization (EUA) status to its cardiac monitoring solution amid the Covid-19 pandemic. VitalPatch has received the approval to detect changes in the QT interval in patients who are hospitalised and undergoing Covid-19 drug treatment. The QT interval detection capabilities of VitalConnect aid clinicians to monitor the patients, who may have developed QT elongation, remotely and continuously in real-time

PerkinElmer has received the EUA from the FDA for the Anti-SARS-CoV-2 ELISA (IgG) serology test, developed by its subsidiary EUROIMMUN. Laboratories that have certification to carry out high complexity tests under Clinical Laboratory Improvement Amendments (CLIA) can use the ELISA to detect IgG antibodies. ELISA offers a 99% specificity and 100% sensitivity to identify antibodies after 21 days following exhibition of symptoms in patients.

Applied DNA Sciences has applied for FDA EUA for its Linea COVID-19 diagnostic candidate. The validation for the EUA was completed in collaboration with company’s neighbour, Stony Brook University Hospital. The diagnostic assay uses reverse transcription polymerase chain reaction (rt-PCR), and can detect small quantities of the viral S gene, which decreases the probability of ‘false negatives’.

Cleanbox Technology has launched CleanDefense, a ‘point-of-use mask decontamination product to tackle the Covid-19 pandemic. The technology uses the UVC light in LED to disinfect products that are hard to clean which are worn on the face or head. The products are expected to remove around 99.99% of the microscopic organisms such as bacteria in seconds.

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