NEW YORK – Aniling said on Thursday that it has obtained CE-IVD marks for three of its cancer sequencing tests.
The Barcelona, Spain-based diagnostics company said its chronic lymphocytic leukemia, colorectal cancer, and liquid biopsy tests are now compliant with the EU's new In Vitro Diagnostic Directive. Aniling has also implemented a quality management system in line with the ISO:13485 standard.
CEO and Cofounder Llorenç Coll said in a statement that obtaining regulatory compliance for the trio of tests is "an important step to consolidate Aniling's market entry strategy and business project."
The tests are based on the firm's genomic and epigenomic unified sequencing (GEUS) technology, which analyzes genetic and epigenetic biomarkers as part of the same test. The first two assays, called GEUS-CLL and GEUS-CRC, can be used to diagnose, monitor, and select the best therapies for patients with CLL and colon cancer, respectively.
GEUS-LB provides information about tumor DNA that can be used to diagnose a patient via liquid biopsy. The Catalan Institute of Oncology, the Institute for Health Science Research Germans Trias i Pujol (IGTP), Hospital Clinic Barcelona, and Munich Leukemia Laboratory all helped to validate Aniling's tests.
The company is a spinout of IGTP's Institute of Predictive and Personalized Medicine of Cancer. It is currently negotiating a Series A round worth €7 million ($7.1 million) that it expects will aid in the clinical validation of its tests, as well as to expand its product menu.