The quality of genetic tests is dependent equally on lab processes and procedures as well as upon the equipment and chemistry used. Because of this, three labs, all using the same sample and the same testing hardware and chemistry, may deliver three different results. The EU has recognized this, and new regulations (IVDR) will apply to all genetic testing labs as of May 2022. Under the new IVDR, genetic testing will require rigorous testing, quality control, and post-market monitoring.
Platomics has developed a software platform that automates all of the quality control processes and procedures that will be required by the forthcoming IVDR regulations for genetic testing labs in Europe. Their platform is also capable of establishing as an entire genetic testing ecosystem with the ability to provide automated clinical analysis and act as a broker of test sales – in addition to automatically assuring improved genetic testing quality.
Platomics has already established partnerships with the test kit supplier Twist, the Red Cross (for genetic testing of blood donations) and a few large labs. They will be focused on the commercializing their platform with an initial focus on central Europe, and with the target of achieving a substantial share of IVDR approved genetic tests in Europe running through their platform.