Corgenix submits 510(k) filing for antibody test kit:
This article was originally published in Clinica
Corgenix Medical, of Denver, Colorado, has submitted a 510(k) marketing application to the US FDA for its IgG anti-AtherOx test kit. The application seeks to allow the use of the test in patients with systemic lupus erythematosus (SLE) and lupus-like disorders such as antiphospholipid syndrome, to assess their risk of vascular injuries or thrombosis. The laboratory test uses the firm's AtherOx technology to detect IgG antibodies against complexes formed by oxidised low-density lipoprotein with beta2-glycoprotein I.