In the age of NGS and multiplex technologies, this is why PCR and IHC remain popular choices for IHC development. Technologies compatible with fast turnaround time.Preference for established platforms, preferably those that can be used for multiple test types, especially if widely placed at laboratories globally.Sample types compatible with standard pathology practice.Preference for technologies with established reimbursement.What does this mean for companion diagnostic development? Generally, a preference for a conservative approach in development: New Technologies and platforms Associated capital expenditures can be passed on to the pharma sponsor.Non-standard sample types Laboratories can charge a premium to accommodate non-standard workflows.Faster Turnaround time Laboratories can provide faster TAT on samples by providing additional labor (or even FTE labor) and accommodating more reagent waste Price per test will of course be higher.Pricing CRO labs can charge value-based pricing This more flexible approach allows for the following.New Technologies and platforms Reimbursement may not be supported by CPT coding Furthermore, if these platforms are utilized for only one test (instead of multiple test types, which is the preference), the assay may not be profitable to offerĪ CRO lab operates with fewer constraints than clinical laboratories:.Non-standard sample types Accommodating non-standard sample types or special sample collection procedures are difficult to incorporate into high-volume pre-analytical procedures For example, FFPE is standard for solid tumors There is very little infrastructure to support fresh frozen or fresh samples.Turnaround time and batching Laboratories prefer to maximize batch sizes to upscale labor efficiencies and reduce reagent waste Tests that are run at low volume may not be compatible with a quick TAT Instead, low volume tests might be batched every 1 or 2 weeks.CPT coding Laboratories depend upon reimbursement according to CPT coding Reimbursement may not necessarily reflect the costs of inputs, or may not cover new technologies The inability to charge a premium for testing services leads to limitations in operations such as the following.One of the challenges developing a companion diagnostic is creating a test that runs well in both clinical trials, and following regulatory approval, clinical testing laboratories Unfortunately, in our experience, the incentive structure for these two laboratory settings operate under different incentive structures:Ī clinical lab operates with the following incentives:
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