Summary: A new demonstrates the high sensitivity of the NeXT Personal test for detecting ctDNA in early-stage lung cancer.

Takeaways:

  1. Ultra-Sensitive Detection: NeXT Personal achieved high sensitivity in detecting ctDNA for early-stage non-small cell lung cancer (NSCLC), including 100% detection in non-adenocarcinomas and 81% in lung adenocarcinomas (LUAD), showcasing its effectiveness even for challenging subtypes.
  2. Prognostic Value: ctDNA levels detected pre-operatively by NeXT Personal were highly prognostic for overall survival, with ctDNA-negative LUAD patients showing a 100% 5-year survival rate and ctDNA-positive patients exhibiting a high risk of relapse.
  3. Clinical Implications: NeXT Personal’s personalized approach and ultra-high sensitivity may transform lung cancer management by enabling earlier intervention, improving survival rates, and supporting Medicare coverage for advanced ctDNA testing.

Personalis published a new study highlighting advancements in lung cancer detection using NeXT Personal, an ultra-sensitive personalized test designed to detect small traces of circulating tumor DNA (ctDNA) in the blood of cancer patients and survivors.

Personalis, in collaboration with Professor Charles Swanton and his colleagues at London’s Francis Crick Institute and University College London, published the results from their TRACERx lung cancer study in Nature Medicine. The study was funded by Cancer Research UK.

Personalized Test for Lung Cancer Detection

In this study, NeXT Personal was used to analyze pre-operative blood samples from a TRACERx cohort of 171 patients with early-stage non-small cell lung cancer (NSCLC). The NeXT Personal test showed high sensitivity for detecting early-stage I-III NSCLC pre-operatively, including 100% of non-adenocarcinomas and 81% of lung adenocarcinomas (LUAD), a common subtype that has previously been one of the most challenging to detect in blood samples because of low ctDNA shedding.

The publication also showed ctDNA levels prior to surgery were highly prognostic for overall survival in early-stage LUAD patients. Early-stage LUAD patients who tested negative for ctDNA with NeXT Personal prior to surgery exhibited a 100% 5-year overall survival rate while patients testing positive had a high overall risk of relapse during that same period. Furthermore, patients who tested positive for very low traces of cancer (below 80 PPM of ctDNA) still had a high risk of recurrence, suggesting the importance of ultra-sensitive MRD testing with NeXT Personal.  

“This study demonstrates the potential of using more sensitive ctDNA tests like NeXT Personal in detecting lung cancer. These tools are important for personalizing care and maximizing the clinical benefit for individual patients,” says Charles Swanton, PhD.


Further Reading


The NeXT Personal assay

Personalis’ NeXT Personal assay utilizes whole-genome sequencing of the patient’s tumor to identify a unique signature of up to ~1,800 variants. A personalized blood test is then created for the patient that can recognize that signature with an ultra-high sensitivity down to ~1 PPM of ctDNA. The findings of this study suggest the potential for using NeXT Personal in guiding management of lung cancer, the second most common cancer in the U.S., with an estimated 238,340 new cases and 127,070 deaths in 2023, and high recurrence rates even in early-stage disease. 

“We designed NeXT Personal to detect residual or recurrent cancer in its earliest stages, and this study shows the clinical importance of that ultra-sensitive detection in early-stage lung cancer,” says Richard Chen, MD, MS, chief medical officer and executive VP of R&D at Personalis. “We look forward to continuing our work with the TRACERx team on the broader clinical performance of ctDNA testing in early stage lung cancer. We expect the subsequent publication of those results will help support our submission for Medicare coverage of NeXT Personal Dx in lung cancer.”