EraGen workshop to address two topics on real-time PCR-based viral monitoring tests

EraGen Biosciences Inc. today announced that it will host a corporate workshop at the upcoming Clinical Virology Symposium, which is being held May 8-11 in Daytona Beach, Fla. The workshop will take place at 1 p.m. on Tuesday, May 10, at the Ocean Center in Daytona Beach.

The workshop will address two topics:

• Steve Young, Ph.D., scientific director of TriCore Reference Laboratories and co-chairman of the Clinical Virology Symposium, will review current methods for the qualification of BK virus and other quantitative viral monitoring assays. Dr. Young's presentation will focus on verification and validation practices, the importance of extractable controls, workflow optimization and his personal experience using EraGen products.
• Mya Thomae, founder and chief executive of Myraqa, will discuss the U.S. Food and Drug Administration's interest in laboratory-developed tests, or LDTs. Ms. Thomae will also cover how tests are cleared and approved by the FDA, and the differences between CLIA documentation requirements and the FDA's quality system regulation, or QSR.

"We are delighted that Dr. Young and Ms. Thomae, both recognized leaders in their respective fields, will join us for our annual corporate workshop at the Clinical Virology Symposium," said Maria Foster, vice president commercial operations of EraGen. "Attendees will come away from the workshop with a deeper understanding of validation practices for real-time PCR-based viral monitoring tests and the regulatory landscape for our industry."

In addition to presenting several scientific posters at the symposium, the company will exhibit at Booth 328.