Personalis, Inc. announced that the results of the TRACERx study, a large prospective cohort of 431 stage I‑III non‑small cell lung cancer patients, have been published in the journal Cell. The study followed patients for more than five years and used Personalis’ NeXT Personal® platform to detect circulating tumor DNA (ctDNA) at a sensitivity of one fragment per million, a level that enables detection of residual disease months before conventional imaging.
The TRACERx data show that NeXT Personal can identify recurrence a median of 5 to 9 months earlier than standard of care imaging, providing clinicians with a powerful tool to guide adjuvant therapy decisions. The study’s robust design and large sample size reinforce the platform’s clinical validity and support its use in routine surveillance, a key factor in securing payer coverage and expanding market share.
The minimal residual disease (MRD) market is projected to grow from roughly $2.5 billion in 2024 to $4.5 billion by 2030, with some estimates suggesting a $20 billion opportunity when broader definitions are applied. Personalis’ recent Medicare coverage for NeXT Personal in breast cancer recurrence monitoring further de‑riskes the product and opens a significant reimbursement pathway that could translate into new revenue streams. The company competes with Natera, Guardant Health, and Adaptive Biotechnologies, but its ultrasensitive platform differentiates it in a crowded field.
Financially, Personalis reported Q3 2025 revenue of $14.5 million, a 44% decline from $25.7 million in the same quarter a year earlier, and a gross margin of 13.2%, down from 34% in Q3 2024. The revenue drop is largely attributable to the wind‑down of the Natera partnership and reduced volume from the VA MVP program, while margin compression reflects higher clinical test costs and lower volume. Management emphasized that the company is focusing on scaling biopharma partnerships and commercializing NeXT Personal, while acknowledging the need to manage costs amid headwinds.
CEO Chris Hall highlighted the platform’s sensitivity, stating, “NeXT Personal can detect approximately one single fragment of tumor DNA in a million.” Chief Medical Officer Dr. Richard Chen added that Medicare coverage for breast cancer “expands access to the test, supporting patients who live with the constant worry of recurrence.” These comments underscore the company’s confidence in the technology’s clinical value and its potential to drive future revenue growth.
The publication of the TRACERx study, combined with Medicare coverage, positions Personalis to accelerate adoption of NeXT Personal across oncology indications. However, the company’s current revenue decline and margin compression signal ongoing operational challenges. Management’s focus on cost discipline and strategic partnerships suggests a cautious but optimistic outlook for the next fiscal year.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.