assays
NoToPharm is developing and validating diagnostic assays based on the detection of autoantibodies against the human self-antigen IFI16 in sera or plasma by a colorimetric Enzyme-Linked ImmunoSorbent Assay (ELISA).
The anti-IFI16 ELISA can be used for the diagnosis of Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE) and Sjogren Syndrome (SjS), with possible application to other autoimmune diseases such as such as Mixed Connectivitis, Polimyositis or Dermatomyositis.
In particular, the assay is suitable for the differential diagnosis of the cutaneous form of SSc with a specificity of 89%. When used in combination with other known serological markers, such as anticentromere (ACA), it gives the highest sensitivity and specificity score (79% and 92% respectively). Worthy of note, anti-IFI16 ELISA detects 25% of SSc patients negative for the other serological markers (ACA and Scl70), thus helping the diagnosis of SSc in these double-negative patients.
These features make ANTI-IFI16 ELISA A VALUABLE TOOL FOR THE DIFFERENTIAL DIAGNOSIS OF SYSTEMIC SCLEROSIS.
Patents
S. Landolfo, M. Gariglio and M. Mondini
Italian patent application "Diagnosi differenziale per la sclerodermia" n° TO2006A000614. PCT filing n° PCT/IB2007/002381
Articles on International peer-reviewed journals
M. Mondini et al.
"A novel autoantigen to differentiate limited cutaneous systemic sclerosis from diffuse cutaneous systemic sclerosis: The interferon-inducible gene IFI16"
Arthritis and Rheumatism. 2006 Dec;54(12), 3939-3944.
M. Mondini et al.
"Role of the Interferon-Inducible Gene IFI16 in the Etiopathogenesis of Systemic Autoimmune Disorders"
Annals of the New York Academy of Science, 2007 Sep; 1110:47-56.
Book chapters:
P. Riboldi et al.
"Interferon-inducible protein IFI16 autoantibodies"
Textbook of Autoantibodies, Y Shoenfeld, PL Meroni, ME Gershwin eds., Elsevier 2006
