Precision medicine reduces unnecessary risks to patients including hazardous side effects as well as ineffective treatments (“trial and error” medicine). Successful implementation of precision medicine is a complex, multistage, cross functional effort between a diagnostic manufacturer (CDx), pharmaceutical (drug) company, and diagnostic lab (biomarker testing). The process is fraught with challenges and risks, both pre- and post- approval. In the CDx space, the approval of a device by the FDA is often viewed as crossing the finish line. Although approval is a major milestone for CDx development, success of a therapeutic program has more layers. The focus of this blog will mainly be on post-commercial factors as it pertains to CDx adoption.
Pre-approval
Before the FDA approves a CDx and therapeutic pairing, challenges and risks to a successful submission include timelines and costs associated with device development, clinical trial testing, regulatory submissions and, of course, the possibility that the biomarker does not adequately (what is adequate?) enrich for a clinical outcome. All this is compounded with trying to keep current with an ever evolving regulatory, scientific and technology landscape. The strategies and management of pre-approval hurdles are somewhat better defined and can be addressed with engagement with experienced partners such as NeoGenomics.
Post-approval
After approval of a drug and CDx, the challenges are centered on commercial adoption and can be categorized broadly into either (1) therapeutic or (2) diagnostic hurdles. These commercialization challenges are seemingly less tangible and less well defined while presenting a higher stake. There is no guidance document or checklist from an authority that can ensure success once completed. Also knowing a therapeutic and CDx is approved, but patients are not receiving the treatment due to commercialization factors can be disheartening.
Therapeutic adoption factors include proper education of health care providers on intended use and effectiveness of the newly approved therapy as well as healthcare coverage of the treatment regimen.
Diagnostic commercialization hurdles include partnering with a diagnostic lab(s) having adequate market reach, timely implementation of the CDx, efficient diagnostic workflow with physician education support and reimbursement coverage. Delays or miscalculation at each step can lead to reduced commercial success of the drug. For example, if the CDx is not offered commercially in a recognized and reputable laboratory, physicians may be reluctant to utilize the testing services. Additionally, if the diagnostic lab offering the CDx has prolonged reporting timelines or if there are high assay failure rates, the pool of therapy recipients dwindles further.
Solutions at NeoGenomics
NeoGenomics engages with pharma in early and late stage CDx programs acting as the CDx developer and/or CAP/CLIA testing laboratory. NeoGenomics is the largest oncology focused diagnostic laboratory in the United States with a Pharma Services and Clinical Diagnostics division, allowing a seamless transition between pre- and post-FDA approval activities. NeoGenomics’ has a Sponsored Testing Program and a “Day 1 Readiness” program to facilitate adoption of a new CDx as well as ensuring there will be testing support concurrent with approval. CDx dedicated teams at NeoGenomics include Medical Science Liaisons, CDx Strategy, Reimbursement, IVD Alliances and Regulatory Affairs.
