AMP 2021 Live Workshop: Establishing an In-House Molecular Profiling Program for Cancer Treatment Selection

Molecular profiling is quickly becoming a critical tool in identifying genomic mutations that indicate a potential response to targeted cancer therapy. Recently, Canexia Health hosted a workshop at the Association of Molecular Pathology Annual Conference (AMP2021) focused on local strategies and experiences from USA Health in Alabama to bring oncology molecular capabilities in-house.

Dr. Thuy Phung, MD, PhD, discussed the requirements for successful set-up and implementation of cancer molecular profiling at USA Health, where she is the medical director of molecular pathology. She explained how faster turnaround time and better management of patient data were among advantages, as well as improved access to clinical trials, which enables precision oncology to be broadly accessible within community practices where most cancer patients are treated.

Key takeaways from the workshop:

• Recent studies have shown that less than 20% of patients are tested for seven recommended biomarkers for non-small cell lung cancers. And, closer to 85% of those diagnosed are not receiving their test results in a timely manner. This is where community-based testing approaches can really be supportive and helpful to patients. 
• At USA Health, the process for selecting and implementing an in-house oncology test that can deliver the molecular information oncologists want and is meaningful to the patient community began with consulting with internal stakeholders — from the CEO to medical technologists. Dr. Thuy called this a “top-down, vertical, and bottom-up approach,” followed by researching the market for the organization’s needs, and evaluating the clinical settings of their environment.
• The focus should be on tests that are high-yield, high-volume, and high-need, with reasonable or lower costs, and that can have a direct impact on clinical management. The next step is choosing the best testing technology or platform to provide molecular data, whether it is single gene, PCR, NGS, or other modalities.
• Formulating a business plan and an operational strategy is critical and should include capital costs, reagents, staffing, reimbursement, and return of investment over a two- or three-year period. 
• Finally, a partnership with a company with a proven track record for helping other labs bring NGS testing in-house contributes to the success of in-house implementation, in terms of cost, efficiencies, and expertise.

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