Will Guardant360 ADLT FDA submission occur by year-end 2026?
Current Prediction
Why This Question Matters
ADLT pricing for Guardant360 would improve unit economics starting 2027. FDA submission status is a key milestone.
Prediction Distribution
Individual Predictions(9 runs)
FDA submission is largely within company control unlike guideline inclusion. Management has indicated it is pending. Strong financial incentive to submit for improved reimbursement.
Submission requires completed clinical and analytical validation packages. These take time but are well-understood processes for GH. Some risk of delays in package preparation.
Management's execution track record supports confidence. ADLT submission is a company-controlled milestone with clear financial benefits.
Company-controlled submission with strong incentive. Regulatory submissions have more predictable timelines than external guideline processes.
FDA submission preparation can encounter unexpected delays. But the financial incentive is strong and management has been executing well.
High probability for a company-controlled milestone. Management track record and financial incentive align.
Company-controlled milestone with good execution history. ~60%.
Strong incentive but preparation timelines can slip. ~58%.
Base rate for planned submissions plus management track record. ~60%.
Resolution Criteria
Resolves YES if FDA submission for ADLT designation occurs by December 31, 2026. Resolves NO if not submitted.
Resolution Source
FDA database, Guardant Health press releases
Source Trigger
ADLT pricing for Guardant360 via FDA submission pending; pricing impact starting 2027
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