We are thrilled to share a momentous achievement in our longstanding collaboration with our esteemed Japanese partners, the Institute of Immunology. This announcement comes during a meeting filled with collaboration and shared successes as Mr. Ito, Mr. Akira, and Ms. Yukiko from the Institute of Immunology paid a visit to our headquarters in Stockholm.
During this collaborative visit, we had the pleasure of discussing plans for the imminent launch of the IMMUNIS Cytokeratin 18F EIA, a project that holds significant promise in the realm of diagnostic medicine. This project has been a work of dedication and innovation, and the collaboration between VLVbio and the Institute of Immunology has been instrumental in its success!
We are happy that the IMMUNIS Cytokeratin 18F EIA has gained official approval as an In Vitro Diagnostic (IVD) for the diagnosis of Non-Alcoholic Steatohepatitis (NASH) from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan! This recognition underscores the product’s efficacy and reliability in contributing to the diagnosis and management of NASH, a condition of growing concern globaly as the epidemiology of the disease keeps increasing at an alarming rate. The need for a biomarker to identify patients with NASH and who are at risk of significant liver disease is of utmost importance, and we are happy that the Keratin 18 assay can assist in that!
The IMMUNIS Cytokeratin 18F EIA ELISA kit
Of equal importance, the IMMUNIS Cytokeratin 18F EIA, developed by the Institute of Immunology, has been included in the national health insurance system in Japan. This recognition ensures widespread accessibility, facilitating broader usage of this diagnostic tool within the Japanese healthcare community.
We are pleased to announce that the official launch date for the IMMUNIS Cytokeratin 18F EIA is scheduled for February 26th to the Japanese market. This date signifies the conclusion of a meticulous research and development process and exemplifies the collaborative efforts between VLVbio and our esteemed partners at the Institute of Immunology. The IMMUNIS Cytokeratin 18F EIA, launched by the Institute of Immunology, is poised to make a substantial impact on the field of NASH diagnosis, providing healthcare professionals with an additional tool to enhance their diagnostic capabilities in Japan.
As we celebrate this milestone and the successful visit from our partners, we extend our gratitude to all individuals who have contributed to the realization of this project, including the dedicated team members and esteemed partners at the Institute of Immunology. Congratulations to you all!
Institute of Immunology president Mr. Ito Yukio and VLVbio CEO
Mrs. Slavica Brnjic holding the finished IMMUNIS Cytokeratin 18F assay.