K-RejX
About Kidney Transplantation and K-RejX
With over 60% of all grafted patients, the kidney transplantation market is significant (240,000 living kidney recipients EU/US). However, several unmet needs remain: No improvement in graft survival in the last 20 years, immunosuppressive drugs responsible for 98% nephrotoxicity after 10 years’ treatment, no reliable and non invasive diagnostic methods to measure immune status in grafted patients.
Chronic antibody-mediated rejection (CAMR) is a recently defined form of late rejection, with a poor prognosis. CAMR is defined by the diagnostic association of specific histological lesions with diffuse C4d deposits in peritubular capillaries and circulating donor-specific anti-HLA antibodies. Thus, the diagnosis of CAMR requires both an invasive biopsy and a non-invasive blood test. The biopsy serves to identify the presence of specific lesions and additional deposits by specific histology and immunohistology techniques. The blood test serves to detect the presence of circulating donor-specific antibodies using high-definition in vitro methods. As the incidence of CAMR appears to increase throughout the post transplant period, the majority of cases are detected upon biopsy for graft deterioration i.e. biopsy for cause. The possibility of using peripheral blood biomarkers to diagnose CAMR would be a step forward in the management of this form of late rejection, notably by enabling more frequent testing of transplant recipients as compared to biopsies, and thus potentially allowing earlier detection (in the absence of loss of graft function) and therapeutic intervention. In order to satisfy this unmet need, we are developing the KRejX biomarker, a non-invasive multigene molecular diagnostic blood test ready to enter into clinical validation and of which the aim is to aid in the identification of kidney transplant recipients at high risk of chronic antibody mediated rejection.