Karen MacLeod

EVP, Regulatory & Clinical Operations

Karen MacLeod

About Karen MacLeod

Karen leads the Clinical and Regulatory Operations team to achieve the highest regulatory and professional standards. With over 30 years of experience in the regulated life science industry and having started her career as a formulation scientist, Karen brings an in-depth understanding of product quality to the Clinical Laboratory team.

Prior to Amprion, Karen was a CMC regulatory expert working for CCS Associates and an independent consultant on a broad range of industry and government clients. A part of a five-member team, Karen helped draft the Drug Master File for the first-ever FDA-approved botanical drug product.

As director of US clinical operations, she leads the first-in-human trials to develop a novel liposome-based cancer imaging agent. Laster, Karen worked as director of manufacturing for a company developing novel targeted delivery cancer therapies.

Karen began her career at Liposome Technology Inc.

Please Note: Important Billing Info

To improve patient access to the SYNTap® Biomarker CSF Test, Amprion offers the following billing options:

  • List price of $1500, with courtesy billing for both Medicare and private insurance.
  • An affordable self-pay price of $995 (patients may qualify for financial assistance and/or interest-free payment options).
  • Prices are effective as of January 1, 2024, and are subject to change.

Please note: Amprion is a Medicare participating provider, however, the SYNTap test does not currently have Medicare coverage determination. Also, Amprion is not yet in network with most insurers.

The SYNTap Biomarker CSF Test has been issued a dedicated CPT® PLA code to be used when billing: 0393U.

For additional information, please visit our billing page.