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If granted, emergency use authorization is anticipated to help roll out standardized, consistent 2019-nCoV testing to public health labs in the US.
The system showed good performance for cervical samples as well as orophyrengeal samples, and required no extraction step.
The Ottawa-based molecular diagnostics maker also plans to enter applied markets in the near term, and ultimately point-of-care infectious disease testing.
The agency plans to make test kits available to state and international partners in the next two weeks. It also provided updated information about the virus.
Mere weeks after the 2019-nCoV sequence was released, firms, agencies, and research groups have already created PCR-based tests.
The Milwaukee, Wisconsin-based firm is part of a growing biotech ecosystem in the region, which has particular expertise in transplant medicine.
The startup is exploring options with potential partners and plans to bring a urinary tract infection test through regulatory channels in the next two years.
The firm has entered the market in Africa with a new collaboration in Ghana. It is also developing instrument-agnostic STI and liquid biopsy tests.
A study of the firm's tests to detect bacterial vaginosis, yeast infections, and trichomoniasis, show they can potentially improve treatment for women with vaginitis.
Microbiology lab and industry stakeholders are increasingly working together to coordinate approaches and generate more clinical utility data for diagnostic testing.
The Washington Post reports that the CDC's SARS-CoV-2 test issues reflect earlier ones it had with Zika virus testing.
NPR writes that even with thousands of new COVID-19 papers, each should be evaluated based on its own quality.
Researchers traced a gene cluster linked to COVID-19 severity to Neanderthals, the New York Times reports.
In PNAS this week: soil bacteria-derived small molecules affect centrosomal protein, microfluidics approach for capturing circulating tumor cells, and more.