Future Announcements, page-10

To your point @goedy there is a single part-government-funded DNA test 'Cologuard' in the US, however, it's a POO test costing around $500. Insurance companies like it because it's cheaper than a colonoscopy.

The various DNA PLASMA (blood) tests in development to date are not good at detecting advanced adenomas (pre-cancerous polyps), they only achieve around 20% sensitivity. The whole point of population screening is early detection.

Rhythm's Colostat on the other hand achieves 87.5% sensitivity for Stage 1, so we can assume at least 60% for advanced adenomas. It offers cheap ELISA-based (readily available), and accurate testing.

Note - Cologuard only achieves 42% sensitivity for advanced adenomas.

Rhythm is now on a mission to manufacture a new automated version of its test kit and then collect the required data regarding the reliability of the device itself. I believe the data will easily meet the IVDR requirements.