New modelling data from diagnostics company Exact Sciences indicates that its Cologuard test for colorectal cancer (CRC) screening has detected almost 600,000 cases since receiving US Food and Drug Administration (FDA) approval in 2014.
Cologuard is an at home test which looks for certain DNA markers and blood in the stool associated with CRC and precancer.
Using estimates based on data from its Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer (DeeP-C Study), Exact found that Cologuard, which is covered in the US by Medicare, was used 16 million times in the past decade.
Exact’s data showed that Cologuard detected advanced precancerous lesions in 525,000 people – a growth type most likely to develop into cancer – and Stage 1 cancer in 42,000.
According to Exact,since its inception in 2014 Cologuard has contributed towards $22bn in cost savings to the US healthcare system with its provision of pre-cancer and early cancer detection as compared to no screening.
“As Exact Sciences marks the 10th anniversary of Cologuard, we reflect on the vital role that it has played in the prevention and early detection of colorectal cancer, making screening more accessible and effective for patients,” said Exact Sciences CEO Kevin Conroy.
“We reached this milestone thanks to long-standing partnerships from health care professionals and advocacy organisations, as well as the support of our dedicated team.”
Exact submitted a pre-market approval (PMA) application to the FDA for Cologuard Plus, a newer version of its screening test in December 2023, with supporting data from the BLUE-C clinical trial (NCT04144738) in which the test demonstrated a 94% sensitivity for detecting CRC.
In its recent second quarter financials for the period ended 30 June 2024, Exact reported revenue of $699m, up from $622m in the same period of 2023.
In other Exact news, the company recently paired up with the Mayo Clinic to bring advanced cancer testing, including its Next Generation Sequencing (NGS) OncoExtra test, to more patients.
