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NEW YORK (GenomeWeb) – Great Basin said today that it has received 510(k) clearance from the US Food and Drug Administration for its stool bacterial pathogens panel, which "addresses a significant unmet need" for an affordable panel that quickly and accurately diagnoses patients suffering from food-borne gastrointestinal distress.

Great Basin noted that its assay simultaneously detects Salmonella, Shigella, Shiga Toxin-producing E. coli, and Campylobacter — bacterial pathogens that make up nearly 95 percent of all food-borne illnesses in the US.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.