QuantumPACK Easy Strep A (HLB Panagene)
QuantumPACK Easy Strep A (HLB Panagene)

BioSquare, a subsidiary of Korea’s precision molecular diagnostics firm HLB Panagene, said on Tuesday that it has registered its “QuantumPACK Easy Strep A” rapid diagnostic kit with the US Food and Drug Administration.

The kit is designed to detect Group A Streptococcus, a bacterium responsible for acute pharyngitis (sore throat) and tonsillitis. It uses fluorescence immunoassay, a light-based antigen detection method, on throat swab samples from patients exhibiting symptoms of respiratory infections.

According to HLB Panagene, the product was developed using the company’s Quantum Dot technology, which enables high-precision detection of various disease-related antigens at the nanometer scale.

Earlier in January, the company received FDA registration for its QuantumPACK Easy RSV Ag — a kit that detects respiratory syncytial virus infection — along with two dedicated analysis devices, QDITS Basic and QDITS Mini.

“We are steadily expanding our FDA registrations and laying the foundation for rapid entry into the global in vitro diagnostics market,” an HLB Panagene official said. “We expect to achieve visible results as we continue to diversify our product lineup.”


andreahaneu@heraldcorp.com