This 20-minute, on-demand presentation sheds light on crucial aspects of bringing a genetic test to market. The transcript of this presentation is also available for download.
Advantages of FDA-Cleared Devices: Explore the benefits of utilizing US FDA-cleared Oragene Dx and ORAcollect Dx saliva collection devices in genetic tests and molecular diagnostics.
Navigating Regulatory Considerations: Gain insights into the regulatory landscape for IVDs and LDTs and the strategic path for bringing genetic tests to market while complying with evolving regulations.
Ease of Use and Customization: Understand the evidence supporting the ease of use of saliva collection devices with U.S. FDA general clearance. Learn how test kits can be customized to meet specific requirements, with streamlined offerings for test providers, and enabling a convenient experience for patients.
Austin Udocor, Director, Regulatory Affairs, DNA Genotek Inc
Tara Crawford Parks, Ph.D., Senior R&D Manager, DNA Genotek Inc