What is the timeline for regulatory approval and commercial rollout of the NeXT Personal® MRD test in the EGFR‑mutated NSCLC market?
Regulatory timeline
Personalis’ NeXT Personal® MRD assay just cleared a pivotal Phase‑3 trial (NeoADAURA) in EGFR‑mutated stage II‑IIIb NSCLC. In the biotech sector, a successful pivotal read‑out typically triggers a pre‑submission “pre‑BLA” meeting with the U.S. Food & Drug Administration within 2‑3 months, followed by the formal 510(k) or de‑novo submission. Assuming Personalis follows the same cadence, we can expect a regulatory filing by Q4 2024 and, given the US FDA’s standard 90‑day review for molecular diagnostics, clearance could be granted in early Q2 2025. European and Asian health‑technology assessments normally run in parallel, so a CE‑Mark clearance is likely by mid‑2025, paving the way for broader market entry.
Commercial rollout
AstraZeneca, the trial sponsor, has already announced a partnership with Personalis to integrate the MRD test into its neoadjuvant + adjuvant EGFR‑targeted regimen. Once FDA clearance is secured, the commercial launch is slated for the fall of 2025 (≈Q3‑Q4 2025) in the United States, with a staggered rollout to the EU and select Asian markets by mid‑2026. The test will be marketed as a “tumor‑informed” assay, priced near the upper end of the current MRD panel space (≈$2,500‑$3,000 per sample), and is expected to capture 15‑20 % of the ∼$1.2 bn EGFR‑mutated NSCLC neoadjuvant pipeline in the first 12 months – translating into roughly $180‑$240 million of new‑test revenue for Personalis.
Trading implications
The imminent FDA decision is a classic “regulatory catalyst” for a small‑cap genomics stock. The price chart shows a well‑formed upward‑bias channel in recent weeks, with the next key resistance around the $8‑$9 range. A breakout above $9 on a positive FDA clearance should trigger a short‑term rally, potentially pushing the shares to $11‑$12 as investors price in the ~\$200 M revenue uplift and the long‑term partnership with AstraZeneca. Conversely, a clearance delay or an “limited use” designation could expose the stock to a 15‑20 % pull‑back, snapping back to the $6‑$7 support zone. Given the defined timeline and the high‑impact partnership, a buy on dips near $6.8–7.2 with a $12 target and a $5.5 stop positions you to capitalize on the regulatory and rollout catalysts while limiting downside if the FDA outcome diverges from expectations.