SHANGHAI, CHINA, November 14, 2022—Jiangsu Bioperfectus Technologies Co., Ltd. (hereinafter referred to as “Bioperfectus”), a leading global company in the molecular diagnostics market, today announced receipt of MDA (Medical Device Authority) approval in Malaysia for Nucleic Acid Extraction Systems, including Nucleic Acid SSNP-2000B, SSNP-3000A, SSNP-9600A, SMPE-960 and Extraction Rapid Kit (Magnetic Bead Method).
Jiangsu BioPerfectus Technologies Co., Ltd. (hereinafter referred to as “Bioperfectus”) applied for the clinical evaluation in XYZ Laboratory (XYZ Laboratory 2009 Ranch Rd. 620 N, STE 325, Austin, TX 78732, USA), a CAP accredited CLIA certified high complexity clinical molecular diagnostic laboratory to perform and report the Bioperfectus Monkeypox Virus (MPXV) Fast Real Time PCR Kit.
Bioperfectus was asked to assist Africa Centres for Disease Control and Prevention (Africa CDC) and the African Society for Laboratory Medicine (ASLM) by providing Ebola Virus Real Time PCR Kits and training to clinicians and other healthcare professionals, which enabled Africa CDC to respond quickly to support hospitals and frontline healthcare staff in epidemics control.
Bioperfectus 𝐂𝐎𝐕𝐈𝐃-𝟏𝟗 𝐂𝐨𝐫𝐨𝐧𝐚𝐯𝐢𝐫𝐮𝐬 𝐑𝐞𝐚𝐥 𝐓𝐢𝐦𝐞 𝐏𝐂𝐑 𝐊𝐢𝐭, 𝐂𝐎𝐕𝐈𝐃-𝟏𝟗 𝐂𝐨𝐫𝐨𝐧𝐚𝐯𝐢𝐫𝐮𝐬 (𝐎𝐑𝐅𝟏𝐚𝐛/𝐍/𝐄) 𝐑𝐞𝐚𝐥 𝐓𝐢𝐦𝐞 𝐏𝐂𝐑 𝐊𝐢𝐭, 𝐂𝐎𝐕𝐈𝐃-𝟏𝟗 𝐂𝐨𝐫𝐨𝐧𝐚𝐯𝐢𝐫𝐮𝐬 𝐚𝐧𝐝 𝐈𝐧𝐟𝐥𝐮𝐞𝐧𝐳𝐚 𝐀/𝐁 𝐕𝐢𝐫𝐮𝐬 𝐑𝐞𝐚𝐥 𝐓𝐢𝐦𝐞 𝐏𝐂𝐑 𝐊𝐢𝐭 are not affected by the Omicron subvariant BA.5.1.3, an offshoot of the BA.5 strain and BF.15, a new mutation of the omicron subvariant BA.5.2.1
BioPerfectus is pleased to announce that Monkeypox Virus (MPXV) Fast Real Time PCR Kit, Monkeypox Virus Genotyping Real Time PCR Kit, Monkeypox Virus/Varicella-zoster Virus/Variola Virus Real Time PCR Kit, Monkeypox Virus and Orthopoxvirus Real Time PCR Kit have been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and are now officially available for Great Britain and Northern Ireland market.