PETALING JAYA: mTouche Technology Bhd said a number of its novel coronavirus RT-PCR detection and diagnostic kits have been assessed and have received final decision and approval by the Medical Device Authority (MDA), under the purview of the Health Ministry, and are now “recommended for use”.
mTouche’s latest announcement follows the one it made in April this year regarding the supply agreement its wholly-owned subsidiary, mTouche International Sdn Bhd, entered into with Network Global Solutions Pty Ltd to promote, market and distribute novel coronavirus (SAR-CoV-2) RT-PCR Detection and Diagnostic Kit by LabGenomics Co Ltd (South Korea) and novel coronavirus (SAR-CoV-2) IgM/IgG Rapid Test Kit by Qingdao Hightop Biotech Co Ltd (China), and other equivalent products in this region.
It was also appointed by Shanghai Fosun Long March Medical Science Co Ltd (China) and Wuhan EasyDiagnosis Biomedicine Co Ltd. (China) as the authorised representative to promote, market and distribute Covid-19 RT-PCR detection and diagnostic kits and Covid-19 IgM/IgG rapid test kits in Malaysia.
In its latest statement, mTouche said the test kits from LabGenomics, Shanghai Fosun and Wuhan EasyDiagnosis were the ones that have received approval.
mTouche executive director Tang Boon Koon said the company submitted five special access applications in total, with three for RT-PCR detection and diagnostic kits which received final decision and approval by MDA.
The IVD Test Assay Evaluation conducted by IMR and MKAK on the three Novel Coronavirus (SAR-CoV-2) RT-PCR Detection and Diagnostic Kit, returned with 100% sensitivity and 100% specificity.
“As for the two IgM/IgG Rapid Test Kit, one have completed the IVD Test Assay Evaluation by MKAK and lab report have been duly submitted to MDA, while the other is still pending IVD Test Assay Evaluation to be performed by IMR,” he said.
In addition, now that approval has been obtained from MDA and is “recommended for use”, mTouche will enter into a contract to officially appoint Premier Diagnostics Sdn Bhd as its warehousing and logistics partner.
Tang said the group is currently in discussions with its manufacturing partner, Shanghai Fosun, to collaborate and distribute Covid-19 mRNA-based vaccine when the product completed its phase 3 clinical trials and ready for mass vaccination and distribution.
“Shanghai Fosun Long March Medical Science Co Ltd is a wholly owned subsidiary of Shanghai Fosun Pharmaceutical Group, who has inked an agreement with BioNTech, the German partner, and Pfizer, on the global development program, with the ultimate aim of securing global supply of a vaccine immediatelty upon regulatory approval. The company will make necessary announcement when there is a material collaboration established,” he added.
Source: The Sun Daily