Aniling has obtained CE certification for its first in vitro diagnostic (IVD) tests for chronic lymphocytic leukaemia, colorectal cancer and liquid biopsy. Aniling has successfully complied with the requirements established by the European Union to obtain the certification in Directive 98/79/EC 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.
This advance means that the new GEUS-CLL and GEUS-CRC tests facilitate the diagnosis, prognosis and selection of the best treatment for each patient with chronic lymphocytic leukaemia and colon cancer, respectively. GEUS-LB is a liquid biopsy test that provides access to tumour DNA in a minimally invasive way and obtains genetic and epigenetic information that allows a faster and more accurate diagnosis.
Cancer is the leading cause of death worldwide, according to the latest data from the World Health Organisation (WHO). The third most common cancer is colon cancer, with 1.8 million people diagnosed in 2020. Chronic lymphocytic leukaemia is the most common type of leukaemia in Western countries (between 20% and 40% of the total).
“The CE marking on our tests is an important step to consolidate Aniling’s market entry strategy and business project” says Dr 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 Dr Miguel A Peinado, co-founder and Chief Scientific Officer of Aniling.
Aniling has a scientific committee made up of renowned experts in clinical genetics and epigenetics such as Dr Susan Clark (Garvan Institute of Medical Research), Dr Elias Campo (Hospital Clinic-IDIBAPS), Dr Manel Esteller (Josep Carreras Leukaemia Research Institute) and Dr Ivo Gut (National Genomic Analysis Centre) and strategic advisors such as Jan Bonel, founder of Visiometrics; Jérôme Marzinski, expert in the medical device market and Jaume Amat, founder of Rob Surgical and Specipig and former president of CataloniaBio & HealthTech.
The tests have been clinically validated in collaboration with leading healthcare institutions such as the Catalan Institute of Oncology (ICO), the Germans Trias i Pujol Research Institute (IGTP), the Hospital Clinic Barcelona and the Munich Leukemia Laboratory (MLL).
The company will focus in the coming months on negotiating a Series A round of €7 million to finance market entry, complete clinical validation and expand the product portfolio.