On October 26, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the launch of the Early Access Program for NeXT Personal Dx, a tumor-informed, whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer (Press release, Personalis, OCT 26, 2023, View Source [SID1234636398]). Designed to help oncologists detect cancer recurrence earlier and aid in treatment decision-making, NeXT Personal Dx is poised to reshape the clinical use of MRD testing by delivering unmatched sensitivity down to the level of one circulating tumor DNA (ctDNA) molecule in a million.
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"Our ultra-sensitive NeXT Personal Dx test has the ability to reveal previously hidden traces of residual cancer, helping to reduce uncertainty for physicians and patients," said Chris Hall, President and CEO of Personalis. "We’re excited to work with oncologists through this Early Access Program to detect cancer even earlier and increase confidence in clinical decisions. We have several MDs that have expressed interest and we are already receiving samples."
NeXT Personal Dx features:
Unprecedented sensitivity and specificity: Industry-leading analytical sensitivity, detecting down to ~1 PPM (parts per million) or 1×10-6 tumor fraction and >99.9% analytical specificity
Whole genome-based tumor-informed assay: Selects up to 1,800 variants to design a highly sensitive and specific personalized tumor signature for each patient
NeXT SENSE technology: Proprietary Signal Enhancement and Noise Suppression Engine that, together with the personalized tumor signature, enables ultra-sensitive detection
The NeXT Personal Dx test is currently available through an Early Access Program to a limited number of clinical customers as the company builds clinical evidence and achieves Medicare reimbursement. The EAP will enable oncologists to access NeXT Personal Dx for clinical use, with a focus on lung cancer, breast cancer, and immunotherapy response monitoring.
Personalis also recently announced data from the groundbreaking TRACERx study investigating the use of NeXT Personal in early-stage lung cancer for MRD and recurrence detection. Personalis, along with collaborators from Cancer Research UK’s Cancer Research Horizons, University College London (UCL), and the Francis Crick Institute, presented data at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress showing the ability of NeXT Personal to detect lung cancer more sensitively and identify cancer recurrence with a median lead time of approximately 6 to 11 months ahead of traditional imaging, and significantly longer than previous TRACERx results.