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In Vitro Diagnostics Financial Sustainability Education

Key Financial Viability Considerations for Laboratorians Considering Bringing Clinical Pharmacogenomics (PGx) Testing into the Laboratory

Laboratories use the same laboratory equipment they invested in for COVID testing to perform PGx testing. With COVID testing reimbursement dropping, many laboratorians are considering implementing PGx testing. PGx test panel design and test utilization that align with payers’ definitions of medical necessity are key to pharmacogenomics laboratories’ financial viability and sustainability. Payers recognize that some clinical pharmacogenomic (PGx) testing has sufficient clinical utility evidence to justify their coverage and reimbursement for their patient populations. They have existing coverage, reimbursement, and billing and coding guidelines. For this webinar, Dr. Winslow will focus on laboratories’ optimizing PGx test panel design and utilization based on payers’ existing coverage and reimbursement guidelines for pharmacogenetic associations that are related to drug metabolizing enzyme gene variants, drug transporter gene variants, and gene variants that predispose a patient to certain adverse events and drug efficacy.
 
Learning Objectives:
  • Make educated financial decisions when considering implementing clinical PGx testing in the laboratory.
  • In terms of time from test implementation to reimbursement, differentiate between implementing a clinical PGx test for which CPT codes and payer policies exist and implementing one for which CPT codes and payer policies do not yet exist.
  • Describe how to optimize PGx test panel design and utilization using payers’ existing coverage and reimbursement guidelines to impact the PGx laboratory’s profits and losses positively.                                                                                                                                                                                                                                                                                                                     

 

Ensuring the Clinical Utility of Pharmacogenomic Tests | Technology Networks

Pharmacogenomic testing uses a patient’s genome to identify their response to a drug, forming a key part of personalized medicine. Hundreds of clinical pharmacogenomics (PGx) tests are available in the United States. With so many tests available, how can you determine that a test is clinically and analytically valid and holds clinical utility?

In this webinar, Dr. Winslow will outline the ACCE Model Project Framework as a tool for evaluating pharmacogenomic tests and describe the key considerations to take into account when implementing these tests. You’ll learn to select the genetic variants to be tested, choose the appropriate genotyping technology, and develop laboratory procedures for sample processing and data analysis.

Learning Objectives:

  • Explain the ACCE Model Project Framework for evaluating genetic tests, specific to PGx tests.
  • Define analytical and clinical validity, clinical utility, and their importance to pharmacogenetic testing stakeholders.
  • Discuss key considerations laboratorians need to ponder when implementing a PGx test that meets ACCE standards.
  • Name real-world clinical PGx tests that have earned pharmacogenomics experts’ approval for their validity and utility                                                                                                                                                          

Driving Sustainable Pharmacogenomics (PGx) Sample Volume

Pharmacogenomics (PGx) testing is a powerful tool in the evolution of personalized medicine. However, for its full potential to be realized, labs must do more than just offer a scientifically sound test—they must figure out how to consistently bring in patient samples at scale. Even with growing clinical interest, many organizations struggle to implement effective and scalable sample acquisition strategies. This educational webinar takes a focused look at the PGx sample sourcing landscape, offering commercialization teams a clear, step-by-step market segmentation and penetration strategy to turn clinical promise into operational success.

Learning Objectives:

  • Understand and Apply Market Segmentation for PGx Testing - Learn how to systematically identify and prioritize high-value market segments to optimize PGx sample acquisition strategies
  • Design and Execute Market Penetration Strategies - Gain practical knowledge on how to build awareness, enable prescribers, integrate infrastructure, engage payers, and activate utilization pathways to drive sustainable growth in PGx testing adoption
  • Translate Strategy into Action Through Real-World Case Application - Apply a stepwise segmentation and penetration framework in practical healthcare settings, using case study insights to enhance operational success, measure outcomes, and scale PGx programs effectively.

Learn more from Dr. Becky Winslow by following her and inGENEious RX Incorporated.