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The firm said that during independent laboratory testing, its assay had 100 percent sensitivity for detecting HIV-1 p24, anti-HIV-1, and anti-HIV-2 in positive samples.

The firm said its rapid antigen test provided 97.3 percent sensitivity and 99.6 percent specificity in clinical studies, and it is developing a saliva-based version.

The test measures changes in white blood cell size, distribution, cell counts, and deformability to determine the state of a patient's immune system.

The companies began working together in 2018, when MEDx was known as Qiagen Translational Medicine, on companion and in vitro diagnostics.

Osang previously granted nonexclusive US distribution rights to the PCR-based test to SG Blocks and has a manufacturing arrangement for the test with Nexus Dx.

The Korean molecular diagnostics firm, a spinoff from genomic services provider Macrogen, also announced plans for an IPO early next year.

The results represent a significant improvement over currently used screening tools and are spurring renewed LDT commercialization and regulatory submission efforts.

The company reported RMB133.9 million (US$20.5 million) for the quarter, up from RMB102.9 million in the same period of 2019.

Earlier this year, Assure Tech's Ecotest COVID-19 serological rapid test for SARS-CoV-2 infection received authorization from Canadian regulators.

The partners believe the platform, which captures high resolution images of CTCs and clusters, has potential applications in early cancer detection and disease monitoring.

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