Mode Diagnostics, a Scottish healthcare products manufacturer, is seeking CE Mark clearance with the European Union for its home colon cancer test. The company is also seeking regulatory approval with the United States Food and Drug Administration in the following 18 months.
According to a new report from Bloomberg News, the global home diagnostics market has an estimated value of $2 to $3 billion and is expanding at a rate of 20 percent every year. Some new at-home diagnostics include tests for sperm count, chlamydia, stomach ulcers, HIV, prostate cancer and colon cancer.
Paul Heaney is the CEO of Mode Diagnostics. In prepared remarks, he said, “Up until this point, medicine and health have been either treatment at the hospital or at the physician’s office. There is a huge appetite for self-diagnostics from people who want discretion or are anxious about hereditary conditions.” He continued, “It has the potential to reduce the cost of care and make healthcare more effective.”
According to information from the company, the test requires less than three minutes to produce accurate results. With traditional lab testing, it can take patients weeks to get results. In addition, the digital version of the device has fewer steps than older, non-digital colon cancer tests. Heaney expects that the company will receive clearance by the end of the year. The company is also working to adapt the electrochemical biosensor found in the colon cancer test for use in at-home chlamydia diagnostic kits.