08/2026 – AstronDX Technologies has received regulatory approval from the Malaysian Medical Device Authority (MDA) for its new LyteStar™ TB-MDR PCR Kit, expanding the company’s molecular diagnostics portfolio for tuberculosis and antimicrobial resistance. The new assay will be commercially available from 1 September 2026.
The LyteStar™ TB-MDR PCR Kit 1.0 enables the detection and differentiation of genetic markers associated with rifampicin and isoniazid resistance in Mycobacterium tuberculosis, targeting the rpoB, katG and inhA genes.
Together with the LyteStar™ TB/NTM Kit 3.1 for detection and differentiation of M. tuberculosis complex (MTBC) and non-tuberculous mycobacteria (NTM), the new assay expands the AstronDX tuberculosis portfolio from pathogen detection and differentiation to the molecular assessment of resistance to the two key first-line anti-tuberculosis drugs.
The approval marks another step in AstronDX’s commitment to build a broader proprietary molecular diagnostics portfolio addressing important emerging diseases and unmet diagnostic needs.
