Research led by the Francis Crick Institute in London shows that an ultrasensitive test designed to pick up small amounts of circulating tumor (ct) DNA in the blood is effective at predicting outcomes for lung cancer patients.
The test, NeXT Personal, has been developed by California-based biotech Personalis. It can detect one part per million of ctDNA in a person’s blood and the current study showed that levels of ctDNA detected prior to surgery to remove lung cancer tumors effectively predicted patient outcomes.
As reported in the journal Nature Medicine, the results of the research showed that the lower the level of ctDNA before surgery the better the patient outcome after surgery.
“Liquid biopsy for detecting ctDNA (namely cell-free DNA derived from a tumor) holds promise as a strategy for personalized clinical management of early-stage cancers,” write lead author Charles Swanton, a professor at University College London and deputy clinical director and head of the Cancer Evolution and Genome Instability Laboratory at the Crick, and colleagues.
However, “detection of preoperative ctDNA in early-stage lung adenocarcinoma is a considerable challenge owing to the low levels of ctDNA in plasma, which are frequently below 100 ppm.”
The study assessed 171 patients with early stage lung cancer taking part in the TRACERx study, a U.K.-based project aiming to match lung cancer patients with new targeted treatments.
The NeXT Personal test is ultrasensitive and was able to detect pre-operative ctDNA in 81% of the patients tested. This included 53% of patients with stage I disease.
Notably, 100% of the patients with negative ctDNA status prior to surgery survived at five years, versus 49% of those with higher-than-average ctDNA levels pre-surgery.
The investigators found that even levels of ctDNA as low as 80ppm, which is not detectable by many commonly used tests, were predictive of a poorer outcome after surgery.
“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,” said Richard Chen, chief medical officer and executive vice president of R&D at Personalis, in a press statement.
“A more sensitive test like NeXT Personal offers the potential of earlier detection and earlier treatment for patients. Similarly, as we see in this study, a negative test can potentially reassure patients and offer the hope of avoiding unnecessary therapy in the future.”
Following on from this study, the NeXT Personal test will be used in lung cancer patients who have already undergone surgery to assess if it is able to accurately predict risk of relapse based on levels of ctDNA in the blood.
