MicroGEM and Workflow Services Joins Forces to Provide a Comprehensive Solution for Fast Saliva PCR SARS-CoV-2 Testing at the Point of Care
MicroGEM, an innovator of person-portable diagnostic devices and nucleic acid extraction products, and Workflow Services, a healthcare software company that provides solutions to capture point-of-care medical data through provider-focused digital workflows, have announced their partnership to simplify COVID-19 test result management. In this agreement designating MicroGEM as a premier partner for PCR point of care testing, Workflow Services now offers optional access to its fully-integrated reporting platform with the MicroGEM Sal6830 SARS-CoV-2 Saliva Test to automate data reporting requirements and simplify care delivery anywhere a test is being performed.
MicroGEM, a Virginia-based life sciences and molecular diagnostics company, develops innovative point-of-need diagnostic devices based on its evolutionary approach to sample preparation. The company recently received Emergency Use Authorization from the FDA for the MicroGEM Sal6830 SARS-CoV-2 Saliva Test, the world’s first saliva PCR test to detect SARS-COV-2 at the point of care in under 30 minutes.
“Our goal is to streamline test administration for providers and ensure secure test results for patients so that point-of-care COVID-19 testing can be implemented with ease and efficiency,” said LeRoy Blake, Chief Commercial Officer at MicroGEM. “The Workflow Services solution enables our customers to quickly document point of care test results, communicate those automatically to the patient, and automatically report results to state and federal health authorities.”
Since its founding in 2013, ImageMover has automated the management of millions of diagnostic images and grown to accommodate numerous clinical workflows and different care settings from pharmacies, to urgent cares, to universities and sports teams. Workflow Services employs an exclusive approach to securely capture and integrate point-of-care medical data, simplifying communication and enhancing patient care. The streamlined workflow reduces errors by capturing data elements through barcode scanning and optical character recognition, and securely stores captured results.
“We are honored to partner with MicroGEM. The MicroGEM innovative PCR test, paired with point-of-care operational support from Workflow Services, brings a compelling, fully integrated solution to the market," said Kevin Houlihan, Workflow Services CEO. "This type of combined offering makes high quality diagnostic testing more accessible and meets the demands of point of care service delivery now and into the future."
The MicroGEM Sal6830 Point of Care PCR System is designed to capture intact virus, a key indicator of infectiousness, and then implements a unique process of thermophilic enzymatic RNA extraction, adsorptive purification, and microscale high-speed RT-PCR to quickly detect SARS-CoV-2. The Sal6830 is simple to operate with non-invasive saliva collection, no extra consumables or sample preparation steps, and easy touchscreen instructions.
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use at the point of care in patient settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. MicroGEM is seeking full FDA approval.
About MicroGEM
MicroGEM democratizes molecular biology by moving complex molecular biology tools out of highly skilled laboratories to non-laboratory settings where they can be used quickly at the point of need. The company's innovative enzymatic approach to nucleic acid extraction provides the foundation for fast sample preparation suitable for PCR analysis. Coupled with its expertise in microfluidics and synthetic biology, MicroGEM is creating the next generation of person-portable diagnostic devices for the management of infectious diseases and other personalized medicine applications.
Contact: Lianne Landers, Sr. Director of Corporate Communications
About Workflow Service
Workflow Services is a healthcare software company that innovates seamless point-of-care medical workflow software solutions for healthcare professionals and patients. The company’s solutions employ exclusive, patented approaches to securely capture and integrate medical data to simplify communication and enhance patient care.
Contact: Shannon Brenkendorff