DELFI Diagnostics Supports Proposed Legislation to Allow CMS to Review New Blood-Based Screening Tests for Lung Cancer

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Dec 13, 2023, 07:00 ET

BALTIMORE and PALO ALTO, Calif., Dec. 13, 2023 /PRNewswire-PRWeb/ -- DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, today announced support for the recently introduced Lung Cancer Screening and Prevention Act (H.R. 6693). Introduced into the U.S. House of Representatives this week by Congressional co-sponsors Vern Buchanan (R-Florida-16), Derek Kilmer (D-Washington-6), Michelle Steel (R-California-45), and Larry Bucshon (R-Indiana-8), the bill seeks to improve timely access to lung cancer screening tests for beneficiaries in the U.S. Medicare program. The proposed legislation would grant the Centers for Medicare & Medicaid Services (CMS) the authority to review U.S. Food and Drug Administration (FDA) approved or cleared new lung cancer screening tests as preventive services under the Agency's existing standards for coverage.

Lung cancer is the leading cause of cancer death among men and women in the U.S. However, fewer than six percent of eligible individuals get screened annually by low-dose CT (LDCT), which is the U.S. Preventive Services Task Force (USPSTF)-recommended standard of care for lung cancer screening. Medicare covers LDCT for all eligible beneficiaries. CMS currently lacks the authority to cover additional approaches to lung cancer screening, such as blood-based ("liquid biopsy") tests, even though access to more screening options may improve lung cancer screening rates. Today, the only path for Medicare to cover a new screening test is for USPSTF to first provide an A/B grade under its review process.

"DELFI applauds Representatives Buchanan, Kilmer, Bucshon and Steel for championing this impactful legislation to provide additional means for CMS to be able to cover new lung cancer screening tests," said DELFI Founder and CEO Victor Velculescu, M.D., Ph.D. "While colorectal and prostate cancers have screening rates between 60 and 70 percent, the lung cancer screening rate is one-tenth of that despite causing far more deaths. CMS already holds the authority to cover new blood-based screening tests for colorectal and prostate cancer in the Medicare population as soon as the evidence is ready. If passed, this bill would enable CMS to use its national coverage determination (NCD) authority and existing coverage standards to review new lung cancer screening tests as well, expediting reviews of products that would enhance the existing lung cancer screening pathway."

CMS has been a good steward of the authority to evaluate and potentially expand access to new technologies in the colorectal cancer space, and this legislation would provide CMS with a similar authority to improve lung cancer screening. The Lung Cancer Screening and Prevention Act would amend title XVIII of the Social Security Act to provide this authority, but does not mandate that CMS either review or cover any new lung cancer screening tests in the Medicare program. The bill states that CMS may review and even rely upon USPSTF ratings during the NCD process, but a USPSTF grade is not a prerequisite for review or coverage. The proposed legislation aligns with U.S. President Biden's Cancer Moonshot initiative focused on expanding equitable access to cancer screening and prevention, and could be a catalyst both to increasing lung cancer screening and lowering lung cancer mortality rates – key objectives of Healthy People 2030.

"Early detection of lung cancer saves lives. Companies like DELFI, with our FirstLook Lung test, are bringing to market sensitive and accessible tests to help find the disease sooner when it is treatable," said Jenn Buechel, DELFI President and Chief Operating Officer. "There is a public health imperative to get more eligible people screened, and we are hopeful that measures like this bill will help overcome a key hurdle to achieving this goal."

The Lung Cancer Screening and Prevention Act is also endorsed by the American Cancer Society Cancer Action Network, LUNGevity Foundation, Prevent Cancer Foundation and numerous major academic medical centers across the country. Full text of the bill will be available on Congress.gov when posted.

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 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, and have the potential to save lives on a global scale. FirstLook Lung, for individuals eligible for lung cancer screening, is our first laboratory-developed screening test and requires a simple blood draw that can be incorporated with routine blood work. The test 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. The DELFI platform applies advanced machine-learning technology to whole-genome sequencing data to assess an individual's cfDNA fragments against populations with and without cancer. FirstLook Lung uses these millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease, with a negative predictive value of 99.7 percent. This test has not been cleared or approved by the FDA. For more information, visit www.firstlooktest.com.

SOURCE DELFI Diagnostics