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November 4, 2020

DNA Genotek wins FDA EUA for saliva collection device

OraSure Technologies subsidiary DNA Genotek has received emergency use authorisation (EUA) from the Food and Drug Administration (FDA) for the use of saliva collection device for SARS COV-2.

OraSure Technologies subsidiary DNA Genotek has received emergency use authorisation (EUA) from the Food and Drug Administration (FDA) for the use of saliva collection device for SARS COV-2.

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The ORAcollect·RNA device can be used for collecting, stabilising, and transporting saliva specimens suspected of containing SARS-CoV-2 RNA.

It marks the second FDA EUA that DNA Genotek has received for its saliva collection devices.

In May, OraSure Technologies announced that its OMNIgene.ORAL saliva collection device (OM-505) was included in FDA EUA granted to P23 Labs.

The EUA enables unsupervised use of ORAcollect·RNA at home or in healthcare settings when used as a component of an authorised self-collection kit for Covid-19 diagnosis.

DNA Genotek Molecular Solutions business unit leader and executive vice-president Kathleen Weber said: “Accessible and accurate testing programmes that include a non-invasive, saliva-based collection option will be essential throughout the duration of the Covid-19 pandemic.

“This second EUA gives our customers additional non-invasive options for SARS CoV-2 sample collection.”

“Saliva sample collection is quick, painless, non-invasive and requires less human contact, both minimising the need for PPE and reducing exposure to potentially infected patients.”

Laboratories use the ORAcollect·RNA collection device as the saliva sample collection method to carry out Covid-19 tests. Because of this, it serves as a vital component of molecular / PCR tests.

Apart from sample collection devices, OraSure is developing a lab-based oral fluid SARS-CoV-2 antibody test and a rapid antigen self-test for Covid-19.

The ORAcollect·RNA and OMNIgene·ORAL sample collection devices have been authorised by the FDA under an EUA only for collecting saliva specimens from people exposed to SARS-CoV-2 and not for any other viruses or pathogens.

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GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
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