Aniling, a biotech company that develops solutions based on next-generation genomic and epigenomic sequencing (NGS) methods for precision oncology, has obtained CE certification for its first in vitro diagnostic (IVD) tests for chronic lymphocytic leukaemia, colorectal cancer and liquid. The biotech is a  CataloniaBio & HealthTech member and one of the finishers of the IVD Accelerator  Programme, promoted by the association to help accelerate start-ups and companies in the field of in vitro diagnostics. The CE mark authorises the company to market the tests throughout Europe.

Aniling has successfully complied with the requirements established by the European Union to obtain the certification in Directive 98/79/EC and the new Regulation on in vitro diagnostic medical devices and has also implemented a Quality Management System according to the ISO 13485 standard.

The GEUS-CLL, GEUS-CRC and GEUS-LB tests are based on the patented GEUS (Genomic and Epigenomic Unified Sequencing) technology which, for the first time, simultaneously and highly reliably analyses genetic and epigenetic  biomarkers in a single clinical test.

"The CE marking on our tests is an important step to consolidate Aniling's market entry strategy and business project" says Llorenç Coll, co-founder and CEO of Aniling. "We are very excited about this milestone that will allow us to bring precision medicine to millions of people" he adds.

"Since 2014, we have focused on improving NGS methods to integrate molecular data into biologically relevant information that meets the high-quality standards required for clinical use. We have managed to improve data quality over other solutions on the market and develop an efficient test that replaces multiple tests and reduces turnaround times," explains Miguel  A Peinado, co-founder and Chief Scientific Officer of Aniling.

Photo: Llorenç Coll and Miguel A.  Peinado, co-founders of Aniling, and Jaume Amat, strategic advisor and Board of  Directors member.