SD Biosensor STANDARD M10 Molecular POC System

SD Biosensor is a diagnostics company headquartered in Suwon-si, Gyeonggi-do, Republic of Korea. Its history page lists the company as founded in 2010 and says it supplies platforms from screening tests to confirmatory tests, including rapid tests, fluorescence immunoassay and molecular systems.

STANDARD M10 is a point-of-care molecular diagnostics system. The M10 MDR-TB assay is an all-in-one cartridge that performs extraction and real-time PCR, detects Mycobacterium tuberculosis complex plus rifampicin and isoniazid resistance in sputum, and returns a result in 86 minutes.

• All-in-one cartridge: extraction and real-time PCR in one disposable.
• Multi-target TB detection: MTB complex plus rifampicin and isoniazid resistance.
• Result in 86 minutes: sputum or sputum sediment sample.
• Room-temperature storage: 2-28 C.
• Sputum pretreatment kit: separate kit of 10 sets for sample preparation.
• Platform range: STANDARD M10 plus STANDARD F and STANDARD Q immunoassay lines.

Provincial TB hospitals can confirm TB and drug resistance within a working day. National TB programs can place systems in district labs. Private hospital labs can offer molecular TB testing alongside smear microscopy.

Simultaneous detection of TB and rifampicin and isoniazid resistance supports earlier treatment decisions. The cartridge stores at 2-28 C, which suits sites without cold chain. An all-in-one cartridge simplifies the workflow. Listing on the Global Fund procurement list opens access to public TB programs.

Decentralized molecular TB testing is a priority for national programs and global procurement bodies. Vietnam is a high TB burden country, so near-patient PCR with drug-resistance detection fits provincial and district labs, subject to registration with local authorities.

HQ at 16 Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Korea. History page lists WHO prequalification for STANDARD G6PD (2024), IVDR CE for STANDARD M10 v2.0 and F10 analyzer (2024), and subsidiaries in the USA, Brazil, India, Indonesia, Germany, Italy and Spain. Vietnam is not listed.