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The clearance of the Binx io CT/NG test marks a milestone for the Johns Hopkins University group that funds early-stage development of rapid STI testing.
The firm said its platform provides sample-to-answer results for two of the most frequently tested sexually transmitted infections, enabling rapid testing and treatment.
The Australian molecular diagnostics firm will use the funds to accelerate commercial expansion in North America and global markets.
The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.
The company received support from a Johns Hopkins University center focused on point-of-care device development for sexually transmitted infections.
The Hologic Aptima Combo 2 and the Cepheid Xpert CT/NG assays have now been cleared for use in throat and rectum samples.
The firm is developing a multipanel test and an antibiotic resistance panel to augment its recently CE marked chlamydia and gonorrhea assay.
The firm said that its point-of-care test delivers laboratory-quality results in about 30 minutes and could be used in the home and other settings.
Abbott said that the MDx platform offers a number of initial assays, including tests for HIV-1, HBV, and HCV, among others.
The deal will enable the Australian firm to distribute its diagnostic tests in the United Arab Emirates, Saudi Arabia, Bahrain, Qatar, and Oman.
In a letter, about two dozen researchers criticize the World Health Organization investigation into the origins of SARS-CoV-2 and call for a new inquiry, the Wall Street Journal reports.
National Geographic reports that nine great apes at the San Diego Zoo have been vaccinated against SARS-CoV-2.
Janet Woodcock, the acting commissioner of the US Food and Drug Administration, speaks with NPR about SARS-CoV-2 testing and vaccines in the US.
In Science this week: genetic study of kidney fibrosis implicates the SOX9-NAV3-YAP1 axis.