DELFI Diagnostics, a developer of accessible blood-based tests for cancer detection, announced the initial commercial introduction of FirstLook Lung. FirstLook is a blood test that offers accurate and personalized results by determining the likelihood of detecting lung cancer through low-dose CT (LDCT), with a negative predictive value (NPV) of 99.7 percent.

FirstLook Lung is based on the science of fragmentomics, the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments in the blood. DELFI’s test applies advanced machine learning technology to whole-genome sequencing data to compare an individual’s cfDNA patterns and characteristics against populations with and without cancer, the company says. FirstLook Lung uses these millions of data points to reliably identify individuals who may have lung cancer, including early-stage disease.

“Cancer screening should be widely accessible and inexpensive to reach the millions of individuals who need it most. With the DELFI fragmentomics technology, we saw an opportunity to innovate beyond today’s liquid biopsy approaches and create a completely new way of enhancing lung cancer screening rates,” says DELFI Founder and CEO Victor Velculescu, MD, PhD. “With only six percent of eligible Americans currently getting screened for lung cancer every year, FirstLook Lung provides an important tool that can be incorporated into routine blood testing to help funnel the right patients to low-dose CT scans.”

Further reading: Lung Cancer Mortality Risk Predicted by Blood Test

FirstLook Lung provides accurate results and clear data to help patients and healthcare providers determine the next best step in the screening process. With high sensitivity, including for early-stage disease, FirstLook Lung identifies the majority of people who will have lung cancer identified by LDCT. FirstLook’s 99.7 percent NPV means that individuals who do not show signs of lung cancer are not likely to have lung cancer found by LDCT.

“More than a decade after strong evidence that LDCT screening saves lives, uptake has been poor, and the opportunity to save lives has not been seized like it should have been,” says Christine Berg, MD, lead investigator for the National Cancer Institute-sponsored National Lung Screening Trial. “Approaches like the FirstLook Lung blood test, focused on the screen-eligible population and providing clinically informative NPV, could move us in the right direction.” 

DELFI is introducing FirstLook Lung through an Early Experience Program with select health systems in the U.S. beginning this fall. 

Further reading: Delfi Diagnostics Enters into Research Agreement with Cancer Center

“We started with lung cancer because the shortfall in screening for this disease is the largest unmet need in cancer early detection today. LDCT screening is underutilized, particularly among individuals often left behind by the U.S. healthcare system,” says Jenn Buechel, MSc., DELFI president and COO. “Our whole-genome machine learning platform is designed to be widely scalable for flexible global deployment. FirstLook Lung is the first of a deep pipeline of tests that we are developing for an array of cancers as well as to monitor the progress of cancer treatments.”