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CapitalBio Tests Certified for Dx Use in China, Europe

NEW YORK (GenomeWeb News) – CapitalBio has been cleared by the Chinese government to use its microarray-based diagnostic tests for autoimmine diseases and it has certified with the CE mark tests for tuberculosis testing in Europe, the company said today.

The Beijing-based diagnostics developer received a certificate from the China State Food and Drug Administration to offer its Antinuclear Antibody Array Test Kits. The certification covers tests for eight different antinuclear antibodies, and it can be used to help diagnose systemic autoimmune diseases including systemic lupus erythematosis, mixed connective tissue disease, Sjögren's syndrome, systemic sclerosis, dermatomyositis, polymyositis, and CREST syndrome, said Capital Bio.

The firm also certified three diagnostic tests for tuberculosis with the CE mark.

One of these microarray-based kits can identify 17 mycobacteria species, which can provide information about an infection and help guide treatment, said Capital Bio. The second kit detects drug resistance in the tuberculosis bacteria and also helps doctors decide a correct treatment course. A third test, which is a real-time PCR-based assay, discriminates between tuberculosis mycobacteria and non-tuberculosis mycobacteria, which doctors could use to choose which microarray assay to use.

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