02/2026 – AstronDX Technologies is pleased to announce that the Thai Food and Drug Administration (FDA) has granted regulatory approval for the LyteStar™ TB/NTM and LyteStar™ Enterovirus HFMD kits. This regulatory milestone expands the AstronDX portfolio within the Thai market, building upon the successful 2025 market introduction and regulatory approvals in Malaysia and addressing the regional demand for high-sensitivity, high-specificity molecular diagnostics tailored to emerging infectious diseases.
LyteStar™ Enterovirus HFMD: Precision Typing for Public Health
The LyteStar™ Enterovirus HFMD Typing RT-PCR Kit 1.0 provides comprehensive detection and differentiation of Enterovirus RNA across diverse clinical matrices, including throat, vesicle, lesion, or rectal swabs (in VTM), as well as whole blood and cerebrospinal fluid (CSF). This four-target multiplex assay is engineered for diagnostic rigor:
- Screening: Targets the highly conserved pan-Enterovirus 5’ UTR region.
- Differential Typing: Specifically identifies EV-A71 (via VP3–VP1 genes) alongside CVA16 and CVA6 (via VP1 gene targets).
By enabling rapid subtyping, the kit supports clinicians in identifying high-risk serotypes associated with severe neurological complications.
LyteStar™ TB/NTM: Enhancing Differential Diagnosis in Mycobacteriology
The LyteStar™ TB/NTM PCR Kit 3.1 facilitates the simultaneous detection of Mycobacterium tuberculosis complex (MTBC) and nontuberculous mycobacteria (NTM) DNA. Validated for use with sputum, bronchial washings, CSF, urine, tissue, and EDTA-whole blood, the kit offers a versatile solution for extra-pulmonary and pulmonary tuberculosis screening. The assay utilizes a sophisticated multi-target approach to maximize diagnostic yield and circumvent potential deletions in the mycobacterial genome:
- MTBC Detection: Dual-target focus on the IS6110 insertion sequence and the MPB64 gene.
- NTM Detection: Dual-target focus on the 16S rRNA (rrs) and RNA polymerase β subunit (rpoB) genes.
