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Delfi, Indigenous Pact Using Blood Test to Improve Lung Cancer Early Detection in Native Communities


NEW YORK – Delfi Diagnostics has partnered with Indigenous Pact on a program bringing its blood-based cell-free DNA fragmentomics assay, FirstLook Lung, to rural Native American communities to expand lung cancer screening and early detection.

Indigenous Pact, a company focused on improving healthcare delivery for Native Americans and Alaska Natives, will make FirstLook Lung through its primary care program. The company partners with tribal health systems and the federal Indian Health Service (IHS) to optimize care and partners with other health networks and companies to provide new services to these health systems. With FirstLook Lung, Indigenous Pact and Delfi hope to increase rates of lung cancer screening in Native communities by offering a simpler option that can be conducted in a primary care setting.

The US Preventive Services Task Force recommends lung cancer screening for individuals 50 to 80 years of age who currently smoke or have quit within the last 15 years and have a 20-pack year or more smoking history. However, the typical screening method for lung cancer, low-dose CT scans, has low uptake with estimated rates of screening between 5 percent and 10 percent of eligible individuals.

Delfi's FirstLook Lung test uses whole-genome sequencing of blood samples alongside a machine learning platform to screen for certain DNA fragmentation profiles associated with lung cancer in cell-free DNA. The test is available in the US as a laboratory developed test (LDT) and Delfi is aiming to pursue further approval from the US Food and Drug Administration for the test as an in vitro diagnostic (IVD), according to Delfi Chief Operating Officer Jenn Buechel.

This month, Delfi also published new research in Cancer Discovery from a large prospective study of FirstLook Lung. The study included more than 900 patients with and without lung cancer to train and validate the assay.

Peter Bach, Delfi's chief medical officer, described the assay as a way to detect early-stage cancer without needing to capture a very specific DNA methylation or mutation associated with cancer in circulating blood samples. The abnormal DNA fragments in cfDNA captured by the FirstLook Lung test reflect the abnormal cell structure of cancer cells, he said.

"Although those [DNA methylation or mutation markers] are found in patients with cancer, they're very hard to find until the patient has very extensive cancer," he explained. "Instead of looking for these narrow areas, [FirstLook Lung] looks to the distribution of fragment patterns of DNA in the blood. We can use the entire genome to tell if somebody has cancer, even though many of the fragments we're looking at aren't specifically involved in the cancer itself."

Other tests that screen for certain mutations or methylation patterns associated with cancer as an early detection strategy include multi-cancer early detection tests such as Grail's Galleri, Guardant Health's Shield, and Exact Sciences' Cancerguard. However, experts have raised questions about the cost and clinical utility of these tests and said the post-screening diagnostic journey for these multi-cancer tests needs to be better defined.

There are also other cancer detection assays in development that analyze DNA fragmentation patterns, including Geneseeq's CanScan test for multi-cancer early detection and Universal DX's Signal-C assay for colorectal cancer detection. In data presented earlier this year, CanScan demonstrated 87 percent sensitivity and 98 percent specificity across tumor types, including lung cancer.

In the Cancer Discovery study of Delfi's FirstLook Lung test, the researchers analyzed DNA fragmentation patterns in cfDNA in a cohort of more than 500 patients with and without lung cancer to create a classifier. They then used that data to train a machine learning model to identify these fragmentation profiles in blood samples.

In the validation portion of the Cancer Discovery study, which included 248 individuals with cancer and 134 without cancer, the overall sensitivity for detecting any stage of lung cancer was 84 percent and the specificity was 53 percent. The sensitivity by stage was 71 percent for stage I cancer, 89 percent for stage II cancer, 88 percent for stage III cancer, and 98 percent for stage IV cancer. The researchers noted that sensitivity was increased in patients with small cell lung cancer, compared to those with non-small cell lung cancer, and among those with metastases.

Bach also emphasized that using low-coverage whole genome sequencing for the FirstLook Lung assay helps improve efficiency and make the test more cost-effective.

"We can have widespread access, which is critical to any screening test, and why it's a real opportunity to work with Indigenous Pact," he said. "Our thesis is that a blood test that's widely accessible can improve [lung] cancer screening rates because of that accessibility and be used as a way of finding the patients who are most likely to benefit from the current recommended screening test, which is the CT scan."

Indigenous Pact CEO Kurt Brenkus said some rural tribal health systems don't have access to CT scans, meaning patients would need to travel to another health system, sometimes hours away, to get a lung cancer screening.

"American Indians and Alaska Natives have the highest health disparities out of any population in the United States, and cancer is no exception," he said. "The fact that this small blood test can be transported into these rural areas and be administered through a primary care setting is a game-changing technology for a population that often has major access issues."

Native communities also have a disproportionate burden from lung cancer, with higher rates of lung cancer incidence and death from lung cancer. A 2021 American Journal of Epidemiology study found lung cancer incidence was elevated for Native Americans and Alaska Natives compared to non-Hispanic White individuals across most regions, in both men and women.

Another report from the American Lung Association found that Native Americans and Alaska Natives were 14 percent less likely to be diagnosed with lung cancer early, when the disease is more treatable.

"By working with Indigenous Pact, we hope we can help improve lung cancer screening rates in the Native community where lung cancer has the greatest burden," Bach said.

Under the collaboration, Indigenous Pact will offer FirstLook Lung to its healthcare partners, starting with tribal nations in the Pacific Northwest. Patients who meet the lung cancer screening eligibility criteria will be offered the test in a primary care setting. Currently, the turnaround time for FirstLook Lung results is 10-14 days from when the sample is received at Delfi's lab. The company also noted that most patients who would receive the test through the Indigenous Pact collaboration are Medicaid eligible and would not have to pay for the screening.

"Indigenous Pact has its own healthcare delivery system with board-certified physicians and multistate specialties where we engage with tribes nationwide," Brenkus explained. "Essentially what we're doing is wrapping around the community [and expanding] the limited resources that are there. We bring a wider range of services and diagnostics and specialty treatments directly into that community."

If the test has a positive result, Indigenous Pact will provide support to help the patient and their provider interpret the results and conduct outreach to the patient. The group will also help the patient get reflex testing for lung cancer with a low-dose CT, including transportation, Brenkus said.

Delfi and Indigenous Pact are also tailoring education and outreach about the assay to the population. Brenkus noted that there is a lot of intergenerational care in the Native community that makes relationship-driven outreach and word of mouth education important.

In the future, the groups hope to expand the program to tribal nations across the country to help improve lung cancer screening in these often-rural populations.

"[Delfi's platform] is something that shows me we can address health disparities in populations that need it most," Brenkus said. "They're starting with lung cancer, but thinking about how they can expand on this platform and get it in these hard-to-reach populations, beyond American Indians, too, is exciting."