COMPANY:

Delfi Diagnostics

''DELFI Diagnostics, Inc...today announced it has received a Clinical Laboratory Permit and Test Approval letter from the New York State Department of Health (NYSDOH). With this permit, DELFI is now authorized to offer its FirstLook™ Lung laboratory-developed test (LDT) in New York. The test is now available in all 50 U.S. states.''

''DELFI Diagnostics, Inc...today announced that five abstracts featuring DELFI technology, including a late-breaker, will be presented at the American Thoracic Society (ATS) 2026 International Conference, taking place May 15-20, 2026, in Orlando, FL. Spanning oral sessions and posters, the five presentations mark a significant milestone for DELFI's fragmentomics platform, featuring the first clinical utility evidence ever generated for a blood-based lung cancer screening approach alongside real-world implementation data from health system collaborators and new evidence on reaching underserved populations with accessible, life-saving early detection.''

"DELFI Diagnostics, Inc...announced the appointment of Dr. Amoolya Singh as Chief Technology Officer. Dr. Singh will spearhead DELFI Diagnostics' strategic technology roadmap, advancing the company's pioneering, AI-powered fragmentomics platform that unlocks unprecedented genomic insights at a transformative price. Dr. Singh joins a distinguished scientific leadership team whose innovations in early cancer detection and treatment monitoring are validated through groundbreaking clinical trials, global research partnerships, and seminal publications in leading medical journals."

"DELFI Diagnostics, Inc...has selected Lahey Hospital & Medical Center (LHMC), part of Massachusetts-based Beth Israel Lahey Health (BILH), to utilize its FirstLook Lung cancer screening test to help improve screening rates in the greater Boston area...Lahey will incorporate DELFI's blood-based lung cancer screening test in the primary care setting on patients eligible for lung cancer screening....In an independent validation, FirstLook Lung was shown to have very high sensitivity in a screening population, including detecting the earliest stages of the disease."

"DELFI Diagnostics...today announced that Incendia Therapeutics will use the DELFI-TF Monitoring assay as part of their suite of assays for evaluation of treatment response and disease progression in patients enrolled in their Phase I clinical trial (NCT05753722)....One key advantage of the DELFI TF assay is that it requires under 1 mL of plasma — considerably less than the volume needed for other cfDNA assays. This low volume is particularly beneficial in early clinical studies that require large volumes of blood for other assessments, such as pharmacokinetic (PK) analyses."

"PALO ALTO, Calif…announced today, the Florida Lung Health Coalition and DELFI Diagnostics, supported by RadNet, Inc..and the American Lung Association, are collaborating to launch a pioneering initiative to transform lung cancer screening and detection in Florida…This new program, announced ahead of Lung Cancer Awareness Month in November, aims to significantly boost early detection rates in Florida where lung cancer screening rates are at only 15.8%, according to the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System. The initiative will be funded through grants and corporate sponsorships by the partners, and it brings together leading healthcare organizations to address the critical need for accessible and efficient lung cancer screening."

P3 | N=564 | CAIRO5 (NCT02162563) | "DELFI Diagnostics...is announcing the publication...in Nature Communications that demonstrates the effectiveness of cell-free DNA (cfDNA) fragmentomes as a means of assessing tumor burden for treatment response, monitoring, and clinical outcome prediction. cfDNA fragmentomes are tumor and mutation-independent, and the approach described in the paper (called DELFI-Tumor Fraction or 'DELFI-TF') requires only 800ul of plasma....The new paper further demonstrates the characteristics of DELFI-TF in two independent validation cohorts. 'DELFI-TF is a locked machine learning classifier validated in two independent cohorts of colorectal and lung cancer patients and can detect clinical outcomes earlier than imaging. This work demonstrates the potential of DELFI-TF to estimate tumor burden for accurate treatment-response monitoring and clinical outcome prediction.'"

"Allegheny Health Network (AHN) and DELFI Diagnostics, Inc...announced a collaboration to evaluate the effectiveness of DELFI Diagnostics' 'FirstLook' blood test to enhance lung cancer screening among western Pennsylvanians who are at risk for developing lung cancer – the leading cause of cancer-related deaths worldwide."

"Indigenous Pact..and DELFI Diagnostics...announced a partnership to utilize DELFI's FirstLook Lung to increase lung cancer screening and early detection in Tribal communities throughout the State of Washington...The collaboration to offer lung cancer screening with FirstLook's blood-based test will initiate in Washington and expand across Tribal Nations....On June 12-14, in San Diego, Indigenous Pact will host its inaugural Regional Tribal Summit. This summit will bring together Tribal leaders to discuss their communities' needs and how best to harness opportunities and address challenges. DELFI will participate in the event to further its understanding of how new technologies like the FirstLook Lung test can aid leaders in their goals to improve healthcare delivery across Indian Country."

"DELFI Diagnostics, Inc...announces the publication of groundbreaking data in the prestigious journal Cancer Discovery from the company's L101 study, 'Clinical validation of a cell-free DNA fragmentome assay for augmentation of lung cancer early detection'. The report details the performance and potential of DELFI's FirstLook Lung test. This milestone study, led by top researchers in the field, marks a significant advancement in aiding blood-based cancer detection."

"DELFI Diagnostics...announced an equity investment by the Merck Global Health Innovation Fund (GHIF), the corporate venture capital arm of Merck & Co., Inc, known as MSD outside the United States and Canada. The capital will accelerate and expand DELFI's development and commercialization of its cancer detection solutions. DELFI's fragmentomics technology applies artificial intelligence (AI) to whole-genome sequencing data to compare an individual's cell-free DNA (cfDNA) patterns and characteristics against populations with and without cancer."

"OSF HealthCare...and DELFI Diagnostics, Inc...today announced a collaboration to utilize DELFI's FirstLook Lung blood-based cancer screening test to help improve screening rates. DELFI's collaboration with OSF was recently highlighted by the Biden Cancer Moonshot to expand accessibility to lung cancer screening...The goal is to further increase screening among eligible OSF patients by incorporating the FirstLook Lung liquid biopsy test into the primary care setting. The test will be offered at 18 locations initially, with plans to make it OSF Ministry-wide within a year....The test works by evaluating patterns of DNA fragments in the blood that reveal the presence of lung cancer."