Geneoscopy Signs Multi-Year Agreement with Labcorp to Distribute Noninvasive Multi-Target Stool RNA (mt-sRNA) Colorectal Cancer Screening Test

Rhea-AI Summary

Labcorp (NYSE: LH) Announces Collaboration with Geneoscopy Inc. to Expand Access to Colorectal Cancer Screening Test - Geneoscopy Inc. and Labcorp have formed a strategic collaboration to increase patient and provider access to a next-generation colorectal cancer screening test. The test, currently under FDA review, offers at-home collection and high sensitivity for early cancer detection. The collaboration aims to reduce barriers to screening and address health inequities by making the test conveniently available through Labcorp's comprehensive screening programs.

Positive

• Strategic collaboration with Labcorp will expand patient and clinician access to Geneoscopy's noninvasive screening test
• Geneoscopy's colorectal cancer screening test, once approved, will offer an innovative, accessible, and reliable option for providers and patients nationwide
• Results from the pivotal CRC-PREVENT trial demonstrate high sensitivity for colorectal cancer and advanced adenomas, with 100% sensitivity for CRC in younger participants (ages 45 to 49)

Negative

• None.

Collaboration expected to increase provider and patient access to potentially life-saving colorectal cancer screening that enables earlier disease detection

ST. LOUIS--(BUSINESS WIRE)-- Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced a strategic collaboration with Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services. This multi-year agreement will increase access to Geneoscopy’s next-generation colorectal cancer screening test, which offers at-home collection and high sensitivity for early cancer detection. Geneoscopy's test is under FDA review. Once approved by the FDA, Labcorp will offer the test, which will be performed by Geneoscopy, enabling health care customers to conveniently order it through Labcorp as part of their comprehensive screening programs.

“Colorectal cancer is one of the most preventable cancers, yet millions of eligible Americans do not get screened as directed by guidelines,” said Vince Wong, Chief Commercial Officer at Geneoscopy. “Working with Labcorp, an organization trusted daily by thousands of clinicians and millions of patients, is an incredible opportunity to expand patient and clinician access to our noninvasive screening test. Given Labcorp’s extensive access to communities across the country, we believe this collaboration will help reduce the barriers to screening and address health inequities.”

Although colorectal cancer ranks second in U.S. cancer-related deaths overall and is the leading cause of cancer death in men younger than 50, research indicates a large proportion of colorectal cancer incidence and mortality is preventable through regular screening, surveillance, and high-quality treatment. Adding to this challenge, colorectal cancer incidence trends are rapidly shifting the patient population to younger individuals; 20% (1 in 5) of colorectal cancers in 2019 were in people 54 years or younger, up from 11% (1 in 10) in 1995, and over the past decade, incidence has increased for advanced disease, especially in people younger than 65 years of age. Geneoscopy’s technology offers this age group convenient at-home test collection with the highest sensitivity currently available for non-invasive CRC screening.

“This agreement builds on Labcorp’s commitment to bring the latest advancements in cancer screening and diagnostic testing to healthcare providers and patients,” said Dr. Brian Caveney, Chief Medical and Scientific Officer at Labcorp. “Geneoscopy’s highly sensitive colorectal cancer screening test, once approved, will be another innovative, accessible and reliable option available to providers and patients nationwide for the detection of colorectal cancer.”

Geneoscopy’s multi-target stool RNA (mt-sRNA) biomarker panel is designed to detect precancerous lesions and colorectal cancer. The company has submitted a Premarket Approval Application (PMA) to the FDA based on the favorable results from the pivotal CRC-PREVENT trial, in which Geneoscopy’s test demonstrated high sensitivity for CRC and advanced adenomas. Notably, for younger participants (ages 45 to 49), sensitivity for CRC was 100%. These results are the highest reported for any noninvasive CRC screening test in any prospective registrational clinical study completed to date.

About Geneoscopy Inc.

Geneoscopy Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. Beyond colorectal cancer screening, Geneoscopy is developing tests for diagnosis, treatment selection, and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit www.geneoscopy.com and follow the company on LinkedIn.

Geneoscopy Inc. Forward-Looking Statements

This release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, which constitute forward-looking statements. These forward-looking statements are based on the Company’s reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict, many of which are outside the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those in the forward-looking statements. Although the Company believes its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved. The actual results may differ substantially from the projected result.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231114283965/en/

Media Contact

Andrea Sampson

Sampson Public Relations Group

asampson@sampsonprgroup.com

Investor Contact

Carrie Mendivil / Ji-Yon Yi

Gilmartin Group

investors@geneoscopy.com

Source: Geneoscopy Inc.

FAQ

What is the strategic collaboration announced by Labcorp (NYSE: LH)?

Labcorp has formed a strategic collaboration with Geneoscopy Inc. to increase patient and provider access to a next-generation colorectal cancer screening test.

What are the key features of Geneoscopy's colorectal cancer screening test?

Geneoscopy's test offers at-home collection and high sensitivity for early cancer detection.

What are the expected benefits of the collaboration between Geneoscopy Inc. and Labcorp?

The collaboration aims to reduce barriers to screening and address health inequities by making the test conveniently available through Labcorp's comprehensive screening programs.

What are the results from the pivotal CRC-PREVENT trial?

Results from the trial demonstrate high sensitivity for colorectal cancer and advanced adenomas, with 100% sensitivity for CRC in younger participants (ages 45 to 49).