Rapid test results in point-of-care settings enable clinicians to act immediately with appropriate treatment. However, personnel conducting these tests are not trained as laboratory technicians, so FDA requires demonstration – via submission of a CLIA Waiver – that these tests are simple and have a low risk of reporting erroneous results. In this audio conference presentation, our speaker provides insight on what should be included in a CLIA Waiver, and what sorts of tests qualify for this treatment. The presentation also reviews the most common mistakes made by diagnostics companies in their CLIA Waiver submissions, and takes a look at some recent trends and FDA's future goals in this area.

This audio conference covers:

• Basic sections of a CLIA Waiver
• Types of tests that qualify for waivers
• Quantitative and qualitative results reporting
• Allowable Total Error and Limit of Erroneous Results
• Common problems with submissions
• Future FDA goals

About the speaker:

Gail E. Radcliffe, Ph.D assists biotech, medical device and diagnostics companies with technical, marketing, regulatory and business development issues. Drawing upon extensive expertise in each of these areas, she brings a unique product development viewpoint to manufacturers and is able to streamline overall business strategy. Dr. Radcliffe helps emerging companies identify potential applications for platform technologies through assessment of technical advantages and disadvantages and matching these qualities with customer needs. She also conducts technical due diligence, monitors product development milestones and provides regulatory strategy assistance. Dr. Radcliffe holds several patents and has worked with clients to obtain funding through angel investments, venture capital and Small Business Innovation Research (SBIR) grants.

She obtained a Ph.D. in Molecular Biology from Brown University in 1986, and then completed a post-doctoral fellowship in molecular immunology at the University of Massachusetts Medical School. While at GENE-TRAK, in the early 90’s, she developed molecular diagnostic assays for several infectious disease organisms. She was also responsible for instituting the clinical affairs group and has since helped usher several companies through the FDA process. Following GENE-TRAK, she joined Cytyc Corporation and worked in both technical and business development roles. Over the past 16 years, Dr. Radcliffe has consulted for diagnostic, medical device and pharmaceutical companies. She is on the board of the Massachusetts Biomedical Initiatives and acts as an advisor to VC firms and several venture-backed biotech companies.

Who should attend?

• Regulatory Associates
• Regulatory Directors & Managers
• Clinical Associates
• Clinical Directors & Managers
• Statisticians