Government and Regulations

FDA Clears First Test to ID Bacteria Associated with Bloodstream Infections


Last month, the Food and Drug Administration cleared a test designed to quickly identify a dozen types of bacteria that can lead to bloodstream infections.

The Verigene GP Blood Culture Nucleic Acid Test, developed by molecular diagnostic firm Nanosphere Inc. of Northbrook, Ill., can identify Staphylococcus (including methicillin-resistant S. aureus, or MRSA), Streptococcus, Enterococcus (including vancomycin-resistant enterococci), and Listeria.

"The current standard of treatment is to provide broad-spectrum antibiotics, including some last-line therapies, such as vancomycin, in order to get coverage for everything," says Mike McGarrity, a Nanosphere executive. "With antibiotic stewardship programs in the majority of hospitals, there is an understanding of the overuse of these last-line therapies and the development of resistance."

Currently, blood cultures can take two to four days to identify certain types of bacteria and determine whether any present are resistant to certain therapies. Once a blood culture is positive, the Nanosphere test can identify bacteria and antimicrobial resistance genes in roughly two and half hours. In a pitch that McGarrity believes will resonate with HM groups, he positions the product as a cost-saver that can reduce length of stay (LOS) for hospitalized patients, as physicians don’t have to wait two days for test results. Quicker identification can also lead to lower mortality rates, he says.

McGarrity, who says Nanosphere will submit an application to the FDA this year for a similar rapid-results test for Clostridium difficile and a broad enteric panel, adds that the test is $75 per use. With LOS reduction and cost savings for targeted de-escalated therapies, he says, there is clear value in the test.

"This gets the attention of stakeholders," he says.

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