MicroGEM has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the MicroGEM Sal6830 SARS-CoV-2 Saliva Test, which provides polymerase chain reaction (PCR) results at the point of care in 27 minutes.
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is the first FDA emergency use authorized saliva test for SARS-CoV-2 using PCR directly at the point of care where people can wait for fast results after providing a sample. Clinically tested during both the Delta and Omicron waves of the pandemic, the MicroGEM Sal6830 SARS-CoV-2 Saliva Test has proven to be robust through the viral mutations that have occurred.
MicroGEM CEO Jeff Chapman, said:
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test will be an essential testing tool in our ongoing efforts to get our nation’s communities and businesses back to regular operations. The introduction of the MicroGEM Sal6830 Point of Care PCR System marks a historic step in our mission to democratize molecular diagnostics by moving ultra-fast, high-performance testing out of laboratories and closer to people at the point of need, thus allowing decisions to be made in real time.
RN, BSN, MPH and COO of Care 4 U (C4UCHC), Vanessa Mills, said:
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test will be an invaluable tool for testing children without scaring them with a stick up their nose. The ability to reliably and quickly test all patients who present with COVID-19 symptoms is a game-changer for our clinics, allowing us to ensure care for people at the moment they need it.
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is easy to operate. Its simple workflow and easy saliva collection reduce workload for healthcare workers and limit their exposure to the sample.
Additional benefits include:
- Non-invasive: Requiring only a small amount of saliva, it eliminates the discomfort of swab testing, making it more comfortable for routine testing.
- Robust with existing variants: Clinically tested during both the Delta and Omicron waves, the multiple SARS-CoV-2 gene targets allow for robust detection of current variants and protect against obsolescence from future variants.
- Portable: The platform’s small size is easily incorporated at testing sites such as mobile testing labs, ambulatory surgical centers, emergency departments, and CLIA-waived testing sites at the workplace.
Dr. Teresa Tyson, DNP, MSN, FNP-BC, FAANP, President and CEO of The Health Wagon, a nurse practitioner managed practice providing medical, dental, and vision healthcare in southwest Virginia, said:
We see many patients who are anxious about nasal swabs so we are excited about the opportunity to offer saliva testing. If patients are comfortable providing the sample and quickly get their results, then they are more likely to be receptive to on-going care and future testing. The MicroGEM Sal6830 SARS-CoV-2 Saliva Test is also a nice fit for our mobile labs with a workflow easily administered by our staff, giving us the ability to provide care to patients within minutes of results.