New Blood Test May Help Better Detect Early Stage Lung Cancer

• Lung cancer is the leading cause of cancer-related deaths globally.
• Most lung cancer cases are not diagnosed until the advanced stage, lowering a person’s 5-year survival rate. 
• Currently, the only screening available for lung cancer is a low-dose CT, which has some limitations. A cancer genomics company says it has developed a blood test for the detection of early-stage lung cancer. 

Lung cancer is the leading cause of cancer-caused death in the world. In 2020, there were about 2 million diagnoses and 1.8 million deaths due to lung cancer. 

The 5-year survival rate for lung cancer depends on the type of cancer a person has, how early it is caught, and if the cancer has moved to other areas of the body. Lung cancer is more curable in its early stages. 

Previous research has shown that most lung cancer cases are diagnosed at an advanced stage because many people do not have obvious symptoms early on.

Currently, the only screening available for lung cancer is a low-dose computed tomography (CT) scan. However, CT scans can sometimes lead to false positives or negatives.

Now, a new way to find lung cancer at its early stages is in the works.

At this year’s European Society for Medical Oncology annual congress, initial findings were presented for a new blood test for the detection of early-stage lung cancer.

The research hasn’t been published yet in a peer-reviewed journal.

How the lung cancer blood test works 

Developed by cancer genomics company Personalis Inc., the new test — called the NeXT Personal ctDNA assay — can detect small traces of circulating tumor DNA (ctDNA) in the blood, which is a marker for residual or recurrent cancer, said Dr. Richard Chen, chief medical officer and executive vice president of research and development at Personalis Inc.

“The NeXT Personal technology leverages whole genome sequencing and advanced noise suppression with NeXT SENSE technology to identify an ultra-sensitive, unique genetic signature derived from a patient’s tumor,” Chen explained to GMHCN. “This unique signature is tracked in the patient’s blood over time to find residual or recurrent cancer, achieving an industry-leading sensitivity of down to ~1 part per million of ctDNA.” 

“This enhanced sensitivity offers the potential for earlier recurrence risk assessment and intervention, earlier detection, more precise monitoring, and substantial advancement in lung cancer care,” he added. 

Identifying recurrence risks prior to surgery

According to Dr. Charles Swanton, the deputy clinical director of the Francis Crick Institute in London and principal investigator for the TRACERx study, the main insight from the work with the NeXT Personal assay in TRACERx concerns disease stratification in early-stage lung cancer. 

“We have at present an imperfect system to understand which patients will typically have a poor clinical outcome following surgical resection of their primary tumor with curative intent, and therefore we aren’t always able to direct additional supplemental therapy, called adjuvant therapy, to those who would benefit it most,” Swanton explained to GMHCN. “This leads to under-treatment of some patients and over-treatment of others. Therefore, there is an urgent need for better ways of stratifying those patients who will do well after surgery and those who will not. This insight was the backdrop to our study.” 

Classifying patients into high and low risk with high fidelity is important, Swanton said, because it opens the door to ”personalized” trials of adjuvant therapy. 

“Being able to withhold treatment from those unlikely to benefit but give it within a population of patients who would benefit could be very impactful,” he noted. “In terms of detection of recurrence, we know that in patients with evidence of ctDNA in the blood following surgery, it is possible to detect relapse almost one year ahead of routine clinical surveillance. As with the pre-operative data, this opens the door to a more personalized treatment approach, where aggressive treatment can be deployed in the early-metastatic setting.” 

Lung cancer blood test in clinical trials

Chen said the NeXT Personal test is currently available for clinical testing as part of an early access program at Personalis.

“Early-stage lung cancer recurs at a very high rate with approximately 20 to 40 percent of patients eventually recurring depending on stage,” he said. “Current methods of recurrence detection like imaging or other blood tests can have limited sensitivity. Finding more sensitive ways to detect residual cancer after treatment or recurrent cancer can open new opportunities to treat or escalate treatment for lung cancer patients earlier.”

Swanton added the next research steps for this new blood test would be to have findings validated in prospective cohorts. 

“This will open the door to routine clinical use and the definition of specific cohorts in which an ultra-sensitive assay can be utilized,” he said. 

Importance of recurrence early identification

After reviewing information about the new NeXT Personal ctDNA assay, Dr. John Roberts, a thoracic surgeon with Lynn Cancer Institute, part of Baptist Health South Florida, at Boca Raton Regional Hospital, told GMHCN that as CT scanning for lung cancer has been shown to decrease mortality from lung cancer more than any medical treatment, so an accurate blood test should have a similar impact.

“All of our blood testing for lung cancer only identifies advanced cancer,” he explained. “Any test that could be used as a screening test for early cancer would be a dramatic advance since our only screen for lung cancer now is a CT scan.”

“Most patients who develop recurrence after treatment for lung cancer are incurable by the time their cancer is discovered,” Roberts added. “Any test that results in an early identification of recurrence would be important.”

Scaling up screening efforts

GMHCN also spoke with Sara Belton, PhD, a nurse navigator for Providence Saint John’s Health Center’s Lung Screening Program at the Cardiothoracic Outpatient Clinic in California, about this study.

As a nurse navigator whose work focuses on lung cancer screening, she said that any tools that can help clinicians in the diagnosis and long-term management of lung cancer are most welcome. 

“There are several research consortia working on developing a blood test for lung cancer genome detection and it is seen by many in the field as the ‘Holy Grail’ for lung cancer diagnosis,” Belton said. “Research success in this area will help clinicians by providing an easier-to-access and potentially more reliable lung cancer screening modality than the current standard, a CT imaging scan, which needs good imaging visualization and clinical interpretation to be most effective. I welcome this news and look forward to hearing more about their results over time.” 

She added that having a low-cost, easily accessible blood test that could help screen people for lung cancer will help medical professionals scale up screening efforts, as is currently low in the United States. 

“Right now, clinical guidelines for lung cancer screening recommend that only current or former smokers with at least a 20-pack year smoking history and who are over age 50 be screened annually for lung cancer,” Belton noted. “However, up to 10 percent of people who develop lung cancer do not have a smoking history and they are not included in these guidelines. These people are often the ones whose lung cancer is found too late for optimal treatment and best outcomes.”

“Having a blood test that could be more broadly administered would help us clinicians find these at-risk non-smokers, and would allow us to intervene and treat them early enough to have good health outcomes and even save them from dying of lung cancer,” she added. “This would be a huge advancement in lung cancer screening and lung cancer care and I am very hopeful that such a blood test will become commercially available in the next few years.”