Aug 8, 2017
TBG ExProbe™ Real Time PCR Based Typing Kit receives Taiwan FDA approval and CE Mark, immediately opens markets
●TBG Typing Kit, ExProbe™ receives CE Mark and Taiwan FDA approval
●One of fastest test products available for Human Leukacyte Antigen diagnostics
●ExProbe™ Typing Kits are also planned for production in TBG Xiamen facility and China FDA registration.
●Key certification for a new TBG product line to enhance HLA IVD pipeline
●Global HLA market is worth roughly $700m AUD and growing at 7% CAGR
Melbourne, Australia, July 19 2017. The Board of TBG Diagnostics Limited (ASX: TDL) (the Company or TBG), an emerging leader in Molecular Diagnostics in the Asian Pacific region, is pleased to announce that our ExProbe™ SE HLA ABCDRDQ (ExProbe™) Typing Kit has received the European CE-Mark as well as the Taiwan TFDA market approval. Receiving these certifications immediately allows access to existing and new markets with a unique TBG Diagnostics product.
The ExProbe™ system is developed based on the real-time PCR (polymerase chain reaction) technology platform. With less than 80 minutes from purified DNA to clinical report, this is one of the fastest molecular Human Leukocyte Antigen (HLA) testing products available. TBG is the first to receive CE-Mark as well as Taiwan TFDA clearance for a real-time PCR test with 5 HLA loci in a single 96 well tray.
Real time PCR platform testing has been widely adapted in nearly all molecular diagnostics laboratories. In addition to transplantation and transfusion, new roles for HLA typing have been discovered in drug hypersensitivity and other auto-immune diseases. The need to perform HLA typing has reached beyond the traditional transplant laboratories. With TBG’s new real-time PCR product, molecular HLA testing is now easy for any laboratory to adopt and perform.
Previously, TBG has been selling its real-time products to the market as RUO (research use only). Now that the products are CE and Taiwan TFDA certified, they can now be used in clinical settings across a larger market. Once certification is attained, the products are released to market immediately. Manufacture of the ExProbe™ kit has to date been in Taiwan. However, with the plan to achieve regulatory approval in China, TBG will soon be able to commence manufacture from its state of the art facility in Xiamen, mainland China.
TBG sees the development of new diagnostics products such as the ExProbe™ Typing Kit and Next Generation Sequencing (NGS) as crucial as these new HLA technologies overtake traditional platforms which are much slower and inefficient. TBG now offers a range of HLA IVD products with four technology platforms: SSP (Sequence Specific Primers), SBT (Sequence Based Typing), Real Time PCR and NGS.
Source：Medigen Biotechnology Corp.
http://www.medigen.com.tw/en/tbg-exprobetm-real-time-pcr-based-typing-kit-receives-taiwan-fda-approval-and-ce-mark-immediately-opens-markets/