Personalis Announced Early Access Launch of NeXT Personal Dx MRD Test With Focus on Lung Cancer, Breast Cancer, and Immunotherapy Response

Personalis has announced the launch of the Early Access Program for NeXT Personal Dx, a new liquid biopsy laboratory-developed test (LDT) specifically designed to detect molecular residual disease (MRD) and cancer recurrence.

The company highlighted the sensitivity of NeXT Personal Dx with analytical sensitivity capable of detecting down to approximately 1 part per million (PPM) or 1×10-6 tumor fraction and over 99.9% analytical specificity. The test is also differentiated as it is a whole genome-based tumor-informed assay, which incorporates up to 1,800 variants. This personalized tumor signature is designed specifically for each patient increasing sensitivity and specificity. The company also highlighted its NeXT SENSE™ technology, a proprietary Signal Enhancement and Noise Suppression Engine.

At present, the NeXT Personal Dx test is being made available through an Early Access Program to a select group of clinical customers. This phased approach allows the company to build clinical evidence and work towards receiving Medicare reimbursement. The program’s primary focus will be on lung cancer, breast cancer, and monitoring immunotherapy responses.

Personalis recently released data from its TRACERx study, an investigation into the use of NeXT Personal Dx in early-stage lung cancer for MRD and recurrence detection. Personalis presented data at the 2023 European Society for Medical Oncology (ESMO) Congress. The study demonstrated the ability of the test to categorize early-stage lung cancer patients into lower and higher recurrence risk groups based on pre-surgical ctDNA levels. Moreover, the analysis revealed that ultra-low levels of ctDNA detected by the NeXT Personal assay played a crucial role in assessing patient recurrence risk. For instance, LUAD patients who tested ctDNA-negative before surgery exhibited a remarkable 100% 5-year overall survival rate and a 94% relapse-free survival rate. In contrast, patients who tested ctDNA-positive prior to surgery had a considerably higher risk of cancer recurrence over a 5-year period.

Additionally, the results indicated that NeXT Personal allowed for the earlier detection of residual or recurrent lung cancer after surgery, with a median lead time of approximately 6 to 11 months compared to traditional imaging. This is a significantly longer lead time than previous TRACERx results, providing a valuable window of opportunity for the intervention and accelerated treatment of high-risk patients.