COVID-19 Diagnostic Testing: Now Available
IMD Path is pleased to announce that it has entered the fight against the 2020 Novel Coronavirus Pandemic that has engulfed the world since the month of March.
IMD is able to perform diagnostic testing for COVID-19 through the development and utilization of its IMD Path SARS-CoV-2 (Covid 19) RT-PCR Assay.
Among the main features of this testing IMD:
Guarantees a 1-2 Business Day Turnaround Time for all patient and client specimens
Provide Physician Guided Support through each testing checkpoint
Provide all clients and offices with test logistics, collection kits, and oversee Health Department Certified Notification of Results
Testing Media Options
Statement of Compliance
This test is a modification of the FDA EUA-authorized assay, CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. The modification is validated using a bridging study and is permitted under the FDA modifications policy in the Policy for Coronavirus Disease-2019 Tests. The bridging study was performed by lntegrated Molecular Diagnostics Pathology, Inc. (IMD Path), 12635 E. Montview Blvd., Suite 360, Aurora, CO 80045. This test has not been cleared or approved by the FDA, however, such clearance/approval is not required, as the laboratory is regulated and qualified under the Clinical laboratory Improvements Amendments (CLIA) to perform high-complexity clinical laboratory testing. This test is used for clinical purposes and should not be regarded as investigational or for research use.