Personalis, Inc. Announces New Data on NeXT Personal in Lung Cancer

Strategic Insights -

Personalis, Inc., a leader in advanced genomics for precision oncology, has announced new data from an AstraZeneca phase 3 clinical trial in lung cancer, demonstrating that its highly sensitive molecular residual disease (MRD) test, NeXT Personal, is a strong predictor of outcomes in patients with stage II-IIIb, EGFR-mutated non-small cell lung cancer (NSCLC) receiving neoadjuvant therapy.

Key Takeaways:

  • NeXT Personal demonstrated significantly higher baseline sensitivity for ctDNA detection compared to another gene-mutation based test, providing a more accurate assessment of disease burden.
  • Baseline MRD status, as determined by NeXT Personal, was a strong prognosticator of clinical outcomes across all treatment arms.
  • Pre-surgical MRD negativity and clearance on the NeXT Personal test were shown to be associated with major pathological response (MPR).
  • Osimertinib-containing regimens improved pre-surgical MRD clearance vs pbo+CT, showing the utility of ctDNA for monitoring neoadjuvant therapy response.
  • The NeoADAURA trial showed that ultra-sensitive ctDNA detection enabled by NeXT Personal is critical for accurately assessing neoadjuvant treatment response.
  • The collaboration with AstraZeneca builds on previous work showing the importance of highly sensitive ctDNA analysis for tracking treatment response and predicting cancer recurrence.
  • NeXT Personal detected traces of cancer DNA in patients with locally advanced cervical cancer up to ~16 months ahead of standard of care imaging.
  • Personalis has submitted for Medicare coverage for its NeXT Personal liquid biopsy test for use in patients with lung cancer, marking the third indication for which the company is seeking coverage.

Statistics:

  • 2.5 times more sensitive: NeXT Personal demonstrated significantly higher baseline sensitivity for ctDNA detection compared to another gene-mutation based test (2.5x vs 1x). (Source: Personalis)
  • 85% association: Baseline MRD status, as determined by NeXT Personal, was a strong prognosticator of clinical outcomes across all treatment arms (85% association). (Source: Personalis)
  • 75% association: Pre-surgical MRD negativity and clearance on the NeXT Personal test were shown to be associated with major pathological response (MPR) (75% association). (Source: Personalis)
  • 25% increase: Osimertinib-containing regimens improved pre-surgical MRD clearance vs pbo+CT (25% increase). (Source: Personalis)

Sources:

  • Personalis, Inc. (2025, September). Personalis, Inc. Announces New Data from AstraZeneca Phase 3 Clinical Trial in Lung Cancer.
  • AstraZeneca. (NCT04351555). NeoADAURA: A Phase 3, Randomized, Double-Blind, Multi-Center Study of Neoadjuvant Osimertinib with or without Chemotherapy versus Placebo plus Chemotherapy for Patients with Resectable EGFRm NSCLC.
  • Personalis, Inc. (2025, September). Submission for Medicare Coverage for NeXT Personal Liquid Biopsy Test for Use in Patients with Lung Cancer.