IGITAL healthcare pioneer Congenica was today given the green light to use its genomic analysis technology in a clinical setting, paving the way for faster and cheaper diagnosis of rare inherited diseases.
The Cambridge-based start-up, which emerged from the Wellcome Sanger Institute seven years ago and now has around 100 employees, is the first in its field to have obtained the CE mark under the CE directive on in vitro diagnosis.
Congenica’s platform processes and interprets a patient’s entire genome sequence to find the most likely causes of conditions ranging from cystic fibrosis, autism and epilepsy to a range of developmental delays.
Currently, these conditions take an average of five years to diagnose on the NHS.
This designation means that Congenica’s data can now be used with a patient’s medical records by specialists in the UK and EU to develop personalized treatment programs.
CEO Dr David Atkins said: “This is an important milestone.
“Our customers can now use our product for the diagnosis of genetic diseases as part of standard care, moving us closer to our vision of genomic medicine routinely integrated into clinical practice globally. “
Jonathan Day, the firm’s senior director of regulatory affairs, said: “Obtaining the CE mark provides clear validation of our compliance with industry best practice standards.
“As the regulatory landscape continues to evolve, we are committed to staying ahead of the game when it comes to meeting the stringent requirements of our industry, with this focus on patient safety being essential to enable large-scale genomic medicine. ladder. “
London-based venture capital firm QVentures was among funds including investment giant L&G, Chinese $ 1.3 billion Tencent fund, and Singapore family office Phua Capital to support a series round. C in November which raised £ 39million.