Precision Medicine and Companion Diagnostics
BIOL-40398
Learn Companion Diagnostics (CDx) for Precision Medicine Online
Dive into the cutting-edge world of precision medicine with our advanced course on Companion Diagnostics (CDx). Insert Companion Diagnostics (CDx) definition here (2-3 sentences)
This dynamic program offers a deep dive into the development pathways, regulatory landscapes, and the intricate business relationships between pharmaceutical and diagnostic companies. Through an in-depth exploration of FDA regulatory frameworks, real-world case studies, and a critical analysis of recent industry collaborations and market trends, students will gain a comprehensive understanding of how CDx is revolutionizing patient care. Whether you're a future scientist, healthcare professional, or business leader, this course is your gateway to mastering the essential tools and knowledge needed to succeed in the rapidly evolving field of personalized medicine.
Who Should Enroll
This course is ideal for:
- Scientists and researchers entering precision medicine roles
- Professionals in diagnostics, biotech, or pharmaceuticals
- Regulatory affairs specialists
- Healthcare professionals interested in targeted therapies
- Business, strategy, or partnership professionals in life sciences
What You'll Learn
By the end of this course, you will have learned Core CDx Competencies and will deeply understand:
Companion Diagnostics Foundations
- Define companion diagnostics and articulate their significance in personalized medicine
- Distinguish CDX from complementary diagnostics and other molecular testing tools
Regulatory & FDA Requirements
- Navigate the regulatory landscape for companion diagnostics, particularly FDA requirements
- Interpret guidance documents relevant to CDx submissions
- Understand analytical validation, clinical validation, and regulatory pathways
CDx Development Pathway
- Analyze the full lifecycle of companion diagnostic development–from biomarker discovery to clinical implementation
- Understand clinical trial integration and CDx-drug co-development timelines
Industry Partnerships & Business Models
- Evaluate business models between pharmaceutical companies and diagnostic companies
- Examine real-world collaboration and partnering strategies in the CDx ecosystem
Market Trends & Future Directions
- Assess current and emerging trends in companion diagnostics, including next-generation sequencing (NGS), multiplex assays, and AI-driven biomarker discovery
- Identify opportunities and challenges in the precision medicine diagnostics market
Course Information
Course sessions
Section ID:
Class type:
Textbooks:
No textbook required.
Policies:
- No refunds after: 2/10/2026
Note:
Schedule:
| Date | Day | Start | End |
|---|---|---|---|
| 2/2/2026 | Mon | 4:00 p.m. | 6:00 p.m. |
| 2/5/2026 | Thu | 4:00 p.m. | 6:00 p.m. |
| 2/9/2026 | Mon | 4:00 p.m. | 6:00 p.m. |
| 2/12/2026 | Thu | 4:00 p.m. | 6:00 p.m. |
| 2/17/2026 | Tue | 4:00 p.m. | 6:00 p.m. |
| 2/19/2026 | Thu | 4:00 p.m. | 6:00 p.m. |
| 2/23/2026 | Mon | 4:00 p.m. | 6:00 p.m. |
| 2/26/2026 | Thu | 4:00 p.m. | 6:00 p.m. |
Instructor:
Larry Mimms, Ph.D.
Chief Scientific Officer, Prometheus Laboratories
Larry Mimms, Ph.D. is chief scientific officer at Prometheus Labs. Previously he served as head of product development for Human Longevity. From 2009 to 2014, Dr. Mimms served as vice president R&D Quidel Corp., a world leader in development of point of care and rapid tests. Prior to his work at Quidel, Dr. Mimms founded VDx LLC in 2008 to develop rapid, point of care HIV diagnostic tests.
From 1994 to 2007 Dr. Mimms held a number of executive positions at Gen-Probe including executive vice president, research and development from 2005-2007 and vice president of development, and vice president of strategic planning and business development. Dr. Mimms initiated and headed up the Gen-Probe blood bank program from 1996 to 2002. In 1996, he and his colleagues won a National Institutes of Health (NIH) contract to develop blood screening assays to detect HIV and HCV nucleic acid. This work and later contracts led to FDA licensure and market introduction of Procleix HIV-1/HCV, Ultrio HIV-1/HCV/HBV assay and the Procleix West Nile Virus assay. As a result of this work, Gen-Probe won the 2004 National Medal of Technology, the highest U.S. honor for technological innovation, for “development and commercialization of new blood testing technologies and systems for the direct detection of viral diseases.” Dr. Mimms served as a member of the Blue Ribbon R&D Panel for the American Red Cross from 2006-2007.
Prior to joining Gen-Probe, Dr. Mimms held various positions in the Hepatitis/AIDS Business Unit at Abbott Laboratories. He was an NIH postdoctoral fellow at Harvard University in cellular and developmental biology prior to joining Abbott Laboratories. He earned a Ph.D. in biochemistry from Duke University and a B.S. in chemistry from Davidson College. In 2014 Dr. Mimms received an honorary doctorate in science from Davidson College for his work on HIV, HCV and HBV.