Early Diagnostic Kit Product for Type 1 DM Patient from the Reseach chaired by Prof. Aulanni’am
Early diagnostic kit made by Laboratory of Bioscience Universitas Brawijaya (UB) is ready to be mass produced and marketed. The kit is first and and favored by bioscience laboratory for Type 1 DM patient based on Reverse Immunochromatoghraphy: RAPID TEST Autoimmunue Marker GAD65. The product is one of the two advanced research product with biofarma which has been started since 1.5 years ago.
According to Prof. Dr. drh. Aulanni'am, DES, the person in charge and head of cooperation project Biofarma-UB, the diagnostic still need more field testing and more petient samples. Furthermore, the product also still has the label For Research Only, and used and marketed by bioscience laboratory limited for research needs. Yet, the product has passed the laboratory and patient test in field with a very good sensitivity (100%) and specified 91.67%. The diagnostic kit for DM patient has been handed over on Wednesday (13/11) to Biofarma, as the funder of the research. On the handover, UB represented by Vice Rector I Academic Affair Prof. Dr. Ir. Bambang Suharto accompanied by Director of Bioscience Laboratory UB Prof. Fatchiyah, M.Kes, PhD. Meanwhile, Biofarma represented by Director of Planning and Development and team. The meeting was attended by Dean of FMIPA Prof. Mardjono, MPhil, PhD and all researcher team of Bioscience Laboratory UB.
On the event, possibilities of management of related product is also discussed, such as who will produce and/or market the product in the future. Fatchiyah said that UB is ready to produce, but still need suitable building or room according the standard of production laboratory in Good Laboratory Practice-Good Manufacturing Practice (GLP-GMP). The product will most likely be commercially marketed by Biofarma as the institution with permit and authority to market similar products.
Soon there will also be a further coordination of the discussion of Biofarma, UB and BinFar (Directorate General of Pharmacy and Medical Equipment Guide) related to the registration of diagnostic products as medical equipment. [biosains/denok/translated by yasmeen]