DELFI Diagnostics Expands Reach with New York Clinical Laboratory Permit to Serve All States

DELFI Diagnostics Secures New York Clinical Laboratory Permit

DELFI Diagnostics, Inc., a pioneer in AI-driven blood tests for cancer detection, has announced a significant advancement in its operational capabilities. The company has been granted a Clinical Laboratory Permit and Test Approval letter by the highly esteemed New York State Department of Health (NYSDOH). This crucial approval allows DELFI to offer its innovative FirstLook™ Lung laboratory-developed test (LDT) throughout New York State, thereby broadening its services to include all 50 states in the U.S.

The NYSDOH is known for its stringent regulatory requirements, recognized as one of the most comprehensive state-level clinical laboratory regulatory standards in the country. This permit confirms the commitment to quality and efficacy that the DELFI team has aspired to since its inception. Susan Tousi, CEO of DELFI Diagnostics, emphasized that this achievement significantly alleviates access issues for patients potentially suffering from lung cancer. "There are millions of individuals across the nation who qualify for lung cancer screenings but are still not receiving them. By passing New York’s rigorous review, we can now extend our reach to all patients, ensuring they have access to a high-standard diagnostic tool that's been meticulously validated," she stated.

The approval represents more than just regulatory compliance; it acts as a solid foundation for DELFI's forward momentum towards obtaining FDA approval for its in vitro diagnostic (IVD) device. The speed with which DELFI has navigated through one of the most demanding regulatory landscapes speaks volumes about its capabilities and dedication to safety and efficacy. DELFI currently holds certifications and accreditations including CLIA certification, CAP accreditation, and ISO 13485 and ISO 27001 certifications, reinforcing its commitment to quality and data security standards across its operations.

The FirstLook Lung Test

FirstLook Lung is specifically designed for patients who meet the United States Preventive Services Task Force (USPSTF) criteria for lung cancer screening. With a simple blood draw that can be integrated into routine blood work, this innovative test offers patients a convenient initial step for detecting lung cancer at its most treatable phase. Boasting a negative predictive value of 99.8%, FirstLook Lung is incredibly effective at identifying individuals at elevated risk for lung cancer, including those with early-stage disease. Following identification, patients are encouraged to pursue additional recommended follow-up assessments, such as guideline-recommended low-dose CT scans.

An interesting aspect of DELFI’s approach is its partnerships with various health systems to implement electronic medical record (EMR) integrations that aim to make blood-based testing accessible to traditionally underserved populations in the United States.

About DELFI Diagnostics

DELFI Diagnostics is at the forefront of developing next-generation, blood-based tests aimed at enhancing the accessibility and reliability of cancer detection methods. Through its proprietary technology, the company utilizes advanced artificial intelligence to analyze circulating cell-free DNA fragments, a methodology referred to as fragmentomics, to identify lung cancer with exceptional sensitivity. FirstLook Lung stands out as the first commercially available blood-based screening test for lung cancer in the U.S. The test’s design and functionality reflect DELFI’s mission to provide innovative medical solutions that prioritize patient well-being.

It is important to note that while FirstLook Lung is not yet cleared or approved by the FDA, the recent NYSDOH permit marks a significant step forward in DELFI’s journey toward regulatory approval and, ultimately, aiming to save lives through earlier detection of lung cancer.

For further information on DELFI Diagnostics and their groundbreaking testing capabilities, visit DELFIDiagnostics.com.

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Source: DELFI Diagnostics