Personalis Announces Publication Validating NeXT Personal® Test for Ultra-sensitive MRD Detection and Cancer Treatment Response Monitoring

Rhea-AI Summary

Personalis, Inc. (Nasdaq: PSNL) announces the validation of its NeXT Personal test, an ultra-sensitive circulating tumor DNA assay, designed to detect cancer recurrence early and improve patient outcomes. The study showcased high analytical sensitivity and specificity, paving the way for potential Medicare coverage. Initial findings at the ESMO Congress indicated improved detection rates in early-stage lung cancer.

Positive

• Validation of NeXT Personal test for detecting minimal residual disease and monitoring therapy response.
• High analytical sensitivity and specificity demonstrated in the study.
• Potential for Medicare coverage based on robust validation results.
• Improved detection rates in early-stage lung cancer shown at the ESMO Congress.

Negative

• None.

Insights

Medical Research Analyst

The introduction of the NeXT Personal ctDNA assay by Personalis, Inc. represents a significant advancement in the field of precision oncology. The ability to detect minimal residual disease (MRD) with high analytical sensitivity and accuracy is a game-changer for oncology treatment and patient monitoring. The test's ultra-sensitive approach is based on whole genome sequencing and advanced noise suppression technology, which can detect ctDNA at a threshold of 1.67 parts per million. This level of sensitivity is critical for early detection of cancer recurrence, potentially allowing for timely and more effective interventions.

The analytical validation study's result of 100% measured analytical specificity is noteworthy. This implies that the test has a high degree of accuracy in identifying ctDNA, minimizing false positives, which can be emotionally and financially draining for patients. The confidence interval reaching up to 100% further solidifies the reliability of the test. For stakeholders, particularly in the healthcare sector and insurance companies, the implications are profound. A reliable MRD test could lower long-term care costs by reducing the need for more aggressive treatments that are often required when cancer is detected at later stages.

Oncologist

The NeXT Personal ctDNA assay's potential to inform clinicians about a patient's response to cancer treatment and the early detection of cancer recurrence, is a vital tool in the arsenal against cancer. The clinical data from the TRACERx Study, indicating that the assay can detect cancer nearly a year ahead of imaging, is particularly compelling for clinical practice. This could lead to a paradigm shift in how we monitor early-stage lung cancer patients, especially given the challenges associated with lung adenocarcinoma detection. The ability to predict clinical outcomes could lead to personalized treatment adjustments, improving patient survival rates and quality of life.

For healthcare providers, the adoption of such technology may streamline patient management and optimize therapeutic strategies. The impact on the stock market could be substantial if Medicare coverage is achieved, as this would likely increase the test's adoption rate and market penetration. Investors may see this as a positive indicator of the company's growth potential and innovation leadership in precision medicine.

Healthcare Economist

The economic implications of an ultra-sensitive ctDNA test like NeXT Personal extend beyond the immediate healthcare savings from early cancer detection and treatment. By reducing the recurrence rates through early intervention, the overall burden of cancer on the healthcare system could be lessened. This is particularly relevant in the context of rising healthcare costs and the need for cost-effective diagnostic tools.

From a macroeconomic perspective, the potential Medicare coverage for NeXT Personal could signal a shift towards more personalized and preventative healthcare measures. This might encourage investment in similar technologies, fostering innovation and competition in the precision oncology market. For investors, the focus might shift to companies that are at the forefront of such disruptive technologies, which could drive stock market trends in the biotechnology sector.

Blood-based assay uses personalized tumor-informed approach designed to detect cancer recurrence early with an ultra-sensitive approach

FREMONT, Calif.--(BUSINESS WIRE)-- 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.

About Personalis, Inc.

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable the selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).

Forward-Looking Statements

All statements in this press release that are not historical are “forward-looking statements” within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the NeXT Personal assay, the potential achievement of Medicare coverage for NeXT Personal, the expected adoption of NeXT Personal in the clinical market, the ability of NeXT Personal to inform or enhance clinical decision-making or to improve or predict patient outcomes, or other future events. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis’ filings with the U.S. Securities and Exchange Commission, including Personalis’ most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption “Risk Factors.” Personalis disclaims any obligation to update such forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240326574824/en/

Investors:

Caroline Corner

investors@personalis.com

415-202-5678

Media:

pr@personalis.com

Source: Personalis, Inc.

FAQ

What is the ticker symbol for Personalis, Inc.?

The ticker symbol for Personalis, Inc. is PSNL.

What is the purpose of the NeXT Personal test?

The NeXT Personal test is designed to help detect minimal residual disease, monitor therapy response, and identify recurrence with high analytical sensitivity and accuracy.

What technology does NeXT Personal leverage?

NeXT Personal leverages whole genome sequencing (WGS) and advanced noise suppression with NeXT SENSE™ technology.

What was the detection threshold of ctDNA in the study?

The study demonstrated a detection threshold of 1.67 parts per million (PPM) of ctDNA with a LOD95 of 3.45 PPM.

What were the initial findings at the 2023 ESMO Congress regarding NeXT Personal?

Initial findings at the 2023 ESMO Congress showed that NeXT Personal's improved detection rates could translate into clinical benefit in early-stage lung cancer, including lung adenocarcinoma (LUAD).