DELFI Diagnostics Launches FirstLook Lung, an Accessible, Accurate New Way to Enhance Lung Cancer Screening Through a Routine Blood Test

FirstLook Lung uses a breakthrough technology of whole-genome machine learning to analyze fragments of cell-free DNA that are markers of cancer in the blood

DELFI leadership to showcase FirstLook Lung science and clinical validation at HLTH 2023

BALTIMORE and PALO ALTO, Calif., Oct. 9, 2023 /PRNewswire/ -- DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, announced today the initial commercial introduction of FirstLook Lung. FirstLook is a blood test that offers a convenient, accurate and personalized result 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. 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," said DELFI Founder and CEO Victor Velculescu, M.D., Ph.D. "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."

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," said Christine Berg, M.D., 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." 

"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," said Jenn Buechel, M.Sc., DELFI President and Chief Operating Officer. "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."

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

DELFI Presentations at HLTH

• Dr. Velculescu will deliver a science and technology presentation on the company's lung cancer solution in a Tech Talk titled, "A 'FirstLook' at DELFI's New Way to Help Detect Early Lung Cancer' on Monday, October 9, at 1:30 pm PDT.
• Peter B. Bach, M.D., DELFI Chief Medical Officer, will be part of the "To Screen or Not to Screen" panel on Tuesday, October 10, from 2:10-2:50 pm PDT, where he will share his insight on the current landscape of early cancer diagnosis and how FirstLook Lung brings a new solution to improve population health.

About Lung Cancer
Lung cancer is the number one cause of cancer death globally and in the United States where it accounts for 25 percent of all cancer deaths–just as many deaths as the other four cancers for which screening is recommended combined (colon, prostate, breast and cervical cancer). Screening rates for those other cancers are in the 60 to 70 percent range, but lung cancer screening with low-dose CT scans is received by only approximately six percent of screen-eligible adults in the U.S. annually. This means that 14.1 million Americans who should be getting screened every year for lung cancer are not doing so. According to the 2021 USPSTF lung cancer screening guidelines, individuals eligible for screening include those 50 to 80 years of age, and who currently smoke or have quit within the last 15 years and have a 20-pack year or more smoking history. Detecting cancer early can improve outcomes. The low rate of lung screening is an important reason why the disease's five-year survival rate in the U.S. is only 23 percent.

About FirstLook Lung
FirstLook Lung is a laboratory-developed test for eligible individuals that can be easily initiated in healthcare provider offices or laboratories. It requires a simple blood draw that can be incorporated with routine blood work. FirstLook helps determine the likelihood of detecting lung cancer through low-dose CT (LDCT), with a negative predictive value of 99.7 percent. FirstLook Lung is not a diagnostic test. A FirstLook Elevated result suggests an increased chance that lung cancer will be detected by LDCT. A FirstLook Not Elevated result suggests a lower chance that lung cancer will be detected by LDCT.

About DELFI Diagnostics
DELFI Diagnostics is developing next-generation, blood-based tests that are accurate, accessible, and deliver a new way to help detect cancer. DELFI tests are built to solve the highest-burden population health issues, including in historically underserved demographics. Our science is based on 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. We combine advanced machine-learning with whole-genome sequencing data to assess an individual's cfDNA fragments against populations with and without cancer. The DELFI platform uses these millions of data points to reliably identify individuals who may have cancer, including early-stage disease. As a result, DELFI tests have the potential to save lives on a global scale.

SOURCE DELFI Diagnostics