The landscape of precision oncology is rapidly evolving with the expansion of tumor-agnostic therapies, creating both opportunities and challenges for healthcare providers in implementing comprehensive genetic testing programs. As of January 2025, eight drugs have received FDA tumor-agnostic approvals, including recent additions such as fam-trastuzumab deruxtecan-nxki (Enhertu) and repotrectinib (Augtyro).
"We want universal genetic testing provided to patients because for most tumors it's becoming the exception of the rule to see guidelines that are not including biomarker-based approaches," says Dr. Pedro Barata, Director of the Clinical Genitourinary Medical Oncology Research Program at University Hospitals Seidman Cancer Center.
Testing Implementation Challenges
Healthcare providers face numerous considerations when implementing genetic testing programs. Key decisions include choosing between tumor testing (somatic) and germline testing, selecting appropriate testing methodologies, and determining optimal timing for sample collection.
Critical factors that clinicians must consider include:
- Selection between tissue biopsy and circulating free DNA testing
- Evaluation of tissue sample age and representation of current disease state
- Interpretation of variant allele fractions
- Choice of testing panels and methodologies (DNA sequencing, RNA analysis, or IHC)
Practical Considerations for Clinical Implementation
The integration of genetic testing into clinical practice requires substantial infrastructure and resource allocation. "We need to put a lot of effort into the care teams and the structure, so that we can provide sequencing testing to patients who come to see us with metastatic solid tumors," Barata emphasizes.
Healthcare facilities must address several operational challenges:
- Establishing efficient testing workflows
- Securing access to genetic counseling services
- Developing protocols for result interpretation and communication
- Creating systems for managing both in-person and remote genetic counseling
Clinical Decision-Making with Limited Data
When confronting situations where biomarker approvals exist but tumor-specific data is limited, clinicians must carefully weigh treatment options. The approach typically involves:
- Prioritizing standard-of-care treatments in earlier lines of therapy
- Reserving biomarker-directed approaches for later-line treatment
- Considering insurance coverage requirements
- Evaluating available evidence across tumor types
"The thought process around prioritizing that specific therapy depends a lot on the data coming from that specific tumor type," Barata notes, highlighting the importance of building evidence bases for different cancer types.
Future Directions
As the field continues to evolve, healthcare providers must remain adaptable and responsive to new developments. The successful implementation of precision oncology programs will require ongoing refinement of testing protocols, enhancement of support services, and continued collection of clinical evidence across tumor types.
