NeXT Personal Dx

NeXT Personal Dx | MRD Liquid Biopsy Lung Cancer Breast Cancer

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NeXT Personal® DxSensitivity matters for patients with early-stage breast cancer

Track early-stage breast cancer patients with ultra-sensitive molecular residual disease (MRD) testing

In an early-stage breast cancer study with 78 patients:

100% (11/11) of patients that relapsed had detectable circulating tumor DNA (ctDNA) prior to relapse¹
39% (45/115) of ctDNA detections were in the ultrasensitive range below 100 Parts Per Million (PPM) (below ~ 0.01% TF)¹
Patients who started with detectable ctDNA and subsequently reached undetectable ctDNA in multiple repeat serial testing did not relapse¹

Clinical Portal

Consent Language

See the results from a 78 patient study in collaboration with The Royal Marsden Hospital and the Institute of Cancer Research, London:¹

~15-month lead time over imaging¹

NeXT Personal Dx detected recurrence, on median, about ~15 months ahead of clinical relapse.¹

100% NPV¹

100% (60/60) of patients that had undetectable ctDNA longitudinally after surgery did not relapse.¹

Ultra-high sensitivity¹

Prior to any treatment, 98% (49/50) of patients with disease had ctDNA detected (at levels as low as 3.73 PPM).¹

Royal Marsden/ICR Data Summary

Abbreviations: NPV, negative predictive value; PPM, parts per million; ctDNA, circulating tumor DNA.

New Data Presented at ASCO 2024

Dr Isaac Garcia-Murillas discusses his research with NeXT Personal® Dx in patients with early stage breast cancer. Dr Garcia-Murillas observed a median 15 month lead time from ctDNA detection by NeXT Personal® Dx testing to clinical recurrence on imaging.

Ultra-sensitive ctDNA testing demonstrated the importance of a negative result for patients with early-stage breast cancer¹

Baseline detection¹

98% (49/50) of baseline samples had ctDNA detected
Median 1,225 PPM; range 3.73 – 112,011.15 PPM

Post-surgical serial ctDNA monitoring¹

Patients that clinically relapsed¹

100% (11/11) of patients that relapsed had detectable ctDNA prior to relapse
Median ctDNA level of first detection = 13.1 PPM
Median Lead Time ~15 months (range 4-41 months) over clinical relapse

Patients that did not clinically relapse¹

100% (60/60) of patients that had undetectable ctDNA longitudinally after surgery did not relapse (NPV).
3 additional patients were initially positive post-surgically but subsequently cleared ctDNA longitudinally and did not relapse

Results: ctDNA detection levels

39% (45/115) of detections were in the ultrasensitive range below 100 PPM (below ~0.01% TF)
45% (18/40) of post-surgery detections were in the ultrasensitive range
Median detection was 366 PPM (range 3.73-112,011)
Median ctDNA level at first molecular relapse detection was 13.1 PPM (range 2.28-14,204)

Resources

2024 ASCO Poster: DAPHNe Trial

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2024 ENDPOINTS Webinar: New ASCO Data

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Listen to our Chief Medical Officer and Executive VP of R&D, Dr. Richard Chen highlight this influential breast cancer study on a local FOX news outlet.

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References

Garcia-Murillas I., et al. (2024, June 2). Ultra-sensitive ctDNA mutation tracking to identify molecular residual disease and predict relapse in early breast cancer patients. ASCO Annual Meeting, Chicago, IL, United States.

PRO-1162-v1

Test Disclaimer

This test is a laboratory developed test (LDT) and is performed in the CAP accredited, CLIA-certified Personalis Clinical Laboratory. The test was developed, and its performance characteristics determined by the Personalis Clinical Laboratory. It has not been cleared or approved by the United States Food and Drug Administration (FDA).

Requirements for Isolated and Extracted Samples

Clinical samples submitted in the form of isolated or extracted nucleic acids will only be accepted if the isolation of nucleic acids occurs in a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/or the CMS.

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