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Blood-based assay uses personalized tumor-informed approach designed to detect cancer recurrence early with an ultra-sensitive approach
Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for precision oncology, today announced a new publication validating the company's NeXT Personal test, an ultra-sensitive, tumor-informed circulating tumor DNA (ctDNA) assay. NeXT Personal is designed to help detect minimal residual disease (MRD), monitor therapy response, and identify recurrence with high analytical sensitivity and accuracy, enhancing the decision-making process and ultimately improving patient outcomes in the ongoing battle against cancer.
"The robust validation results in this publication provide a foundational building block towards achieving Medicare coverage for NeXT Personal," said Richard Chen, MD, MS, Chief Medical Officer and Executive Vice President, R&D of Personalis. "We are laser-focused on developing and publishing data to establish NeXT Personal as a leading MRD test."
In the analytical validation study published in Oncotarget, scientists from Personalis evaluated NeXT Personal by testing samples from over 120 patients across nine cancer types and paired tumor and normal cell lines. The NeXT Personal technology leverages whole genome sequencing (WGS) and advanced noise suppression with NeXT SENSE™ technology to identify a unique genetic signature derived from a patient's tumor based on up to ~1,800 variants. Through NeXT Personal, a custom panel is created to detect trace amounts of ctDNA from patient blood samples.
The analytical range measurements demonstrated a detection threshold of 1.67 parts per million (PPM) of ctDNA with a LOD95 of 3.45 PPM, highlighting NeXT Personal's ultra-high analytical sensitivity. Results of the study showed 100% measured analytical specificity, with a confidence interval spanning 99.92 to 100%.
"We designed NeXT Personal to enable another big leap in ctDNA sensitivity and specificity," said Chen. "Taken together, the results show NeXT Personal's capability for ultra-sensitive detection of ctDNA in patient plasma samples and the test's potential to reliably inform clinicians and patients on residual cancer, cancer treatment response, and cancer recurrence through ctDNA detection, earlier than conventional detection approaches," Chen noted.
At the 2023 European Society for Medical Oncology (ESMO) Congress, initial findings showed that NeXT Personal's significantly improved detection rates could translate into clinical benefit in early-stage lung cancer, including lung adenocarcinoma (LUAD), one of the most common and challenging subtypes of non-small cell lung cancer (NSCLC) to identify in blood samples. This data from the TRACERx Study demonstrated the assay was able to find cancer nearly a year ahead of imaging and was predictive of clinical outcomes in early-stage lung cancer patients.
Posted In: PSNL
