Geneoscopy Expands Services After New York Health Permit
Geneoscopy Gains State Permit for Laboratory Services
Geneoscopy, Inc., a pioneering life sciences company dedicated to improving gastrointestinal health through innovative diagnostic tests, has recently secured a crucial laboratory permit that allows it to operate across all 50 states and the District of Columbia. This significant development follows the approval from the New York State Department of Health, enabling Geneoscopy to broaden its reach and provide essential laboratory services nationwide.
Introduction of ColoSense™ Test
The achievement of this permit is particularly timely as Geneoscopy prepares to launch its first commercially available laboratory test, known as ColoSense™. This groundbreaking test is an FDA-approved, noninvasive screening method that utilizes stool samples to detect colorectal cancer (CRC) and advanced adenomas. Geneoscopy's focus is to enhance the accessibility of effective screening tools, thus potentially saving lives by facilitating early detection and treatment.
The Role of New York's Clinical Laboratory Evaluation Program
New York's Clinical Laboratory Evaluation Program (CLEP) is renowned for its stringent regulation of clinical laboratories. This program ensures that high standards of accuracy and reliability are maintained, especially in laboratories processing specimens from New York residents. By acquiring this permit, Geneoscopy demonstrates its commitment to uphold these rigorous standards and deliver accurate results to healthcare providers and patients alike.
Expert Insights on the Quality Assessment
"Earning New York's CLEP permit confirms that our laboratory meets the highest standards of quality and precision," states Julie LaRocca, Senior Vice President of Quality Assurance and Regulatory Affairs at Geneoscopy. The company's drive is to provide a reliable, noninvasive option for detecting colorectal cancer early, and this permit signifies a significant step forward in making the ColoSense test available to all patients, nationwide.
Addressing the Colorectal Cancer Challenge
Colorectal cancer stands as the second deadliest form of cancer in the United States, yet it remains tragically under-screened. Many eligible individuals avoid necessary screenings due to discomfort associated with traditional procedures or a misguided perception of their own risk levels. Geneoscopy's mission is clear: by expanding access to innovative and more comfortable screening methods like ColoSense, they aim to eliminate barriers for patients and encourage proactive health management.
The Innovation of ColoSense Testing
ColoSense is a unique test that utilizes a stool sample to qualitatively detect the presence of neoplasia-associated RNA markers as well as occult hemoglobin. A positive result may suggest the presence of CRC, advanced adenomas, or precancerous lesions, prompting the need for further investigation with a colonoscopy. Notably, this test is designed for adults aged 45 and older who are at average risk for colorectal cancer, serving as a vital tool in early intervention.
Clinical Validation and Impact
The efficacy of Geneoscopy’s ColoSense has been showcased in their pivotal CRC-PREVENT trial, with results published in a prestigious medical journal. This validation underscores the effectiveness of their RNA-based assay technology, which provides a comprehensive view of disease activity without relying heavily on age-related patterns. Such innovations are essential in ensuring that patients receive the most relevant and accurate diagnostics tailored to their health needs.
About Geneoscopy, Inc.
Geneoscopy, Inc. prides itself on being an accredited laboratory under Clinical Laboratory Improvement Amendments (CLIA) and recognized by the College of American Pathologists (CAP). Their focus is on utilizing a patented stool-derived RNA biomarker platform to empower both patients and providers in managing gastrointestinal health. Beyond their flagship test, ColoSense, Geneoscopy is actively collaborating with leading academic institutions and biopharmaceutical companies to develop additional diagnostic solutions for various gastrointestinal diseases.
Frequently Asked Questions
What is ColoSense?
ColoSense is a noninvasive stool test designed to screen for colorectal cancer and advanced adenomas by detecting RNA markers.
Why did Geneoscopy receive a permit from New York State?
The permit allows Geneoscopy to expand its laboratory services to operate across all states, adhering to New York's high regulatory standards.
How does ColoSense improve cancer screening?
ColoSense offers a more comfortable and noninvasive option for patients, potentially increasing screening rates among those reluctant to undergo traditional methods.
What are the eligibility criteria for ColoSense?
ColoSense is intended for adults aged 45 and older who are at average risk for developing colorectal cancer.
What is Geneoscopy's mission?
Geneoscopy aims to transform gastrointestinal health through innovative diagnostics, empowering patients with accessible and reliable screening options.
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