FDA approvals

Nanosphere receives FDA clearance for gram-negative bacteria test

Nanosphere Inc. announced the FDA has granted the company clearance to market an in vitro diagnostic test for identifying gram-negative bacteria associated with bloodstream infections, according to a company press release.

The Verigene gram-negative blood culture test was designed to identify a range of gram-negative bacteria and is capable of determining antibiotic resistance up to 2 days faster than conventional testing methods. The test can discern markers such as the KPC and NDM genes, which are associated with carbapenem-resistant Enterobacteriaceae.

“Antimicrobial resistance poses a significant threat and significantly affects how we practice medicine, as the availability of viable antibiotics to treat these life-threatening infections is decreasing,” Richard Thomson, PhD, director of clinical microbiology at NorthShore University HealthSystem, said in the release. “Knowing what bacterium is responsible for the infection and which antibiotics it’s resistant to is an important step toward ensuring that our patients are receiving targeted therapy and that we are not using any unnecessary antibiotics.”

Nanosphere also markets the Verigene gram-positive blood culture test. Compared with conventional techniques, the test was able to identify most gram-positive bacteria — including MRSA and vancomycin-resistant enterococci — up to 42 hours faster, leading to improved antibiotic use in patients. The test also was more cost-effective.

“We continue to see growing demand for our infectious disease tests, particularly our gram-positive blood culture test, which is proving to reduce health care spending, prevent antibiotic resistance and, most importantly, save lives,” said Michael McGarrity, president and CEO of Nanosphere. “Continued menu expansion with our [gram-negative blood culture] and enteric tests will provide additional value to our customers and patients and serve as the basis for our continued growth as a company.”

Nanosphere Inc. announced the FDA has granted the company clearance to market an in vitro diagnostic test for identifying gram-negative bacteria associated with bloodstream infections, according to a company press release.

The Verigene gram-negative blood culture test was designed to identify a range of gram-negative bacteria and is capable of determining antibiotic resistance up to 2 days faster than conventional testing methods. The test can discern markers such as the KPC and NDM genes, which are associated with carbapenem-resistant Enterobacteriaceae.

“Antimicrobial resistance poses a significant threat and significantly affects how we practice medicine, as the availability of viable antibiotics to treat these life-threatening infections is decreasing,” Richard Thomson, PhD, director of clinical microbiology at NorthShore University HealthSystem, said in the release. “Knowing what bacterium is responsible for the infection and which antibiotics it’s resistant to is an important step toward ensuring that our patients are receiving targeted therapy and that we are not using any unnecessary antibiotics.”

Nanosphere also markets the Verigene gram-positive blood culture test. Compared with conventional techniques, the test was able to identify most gram-positive bacteria — including MRSA and vancomycin-resistant enterococci — up to 42 hours faster, leading to improved antibiotic use in patients. The test also was more cost-effective.

“We continue to see growing demand for our infectious disease tests, particularly our gram-positive blood culture test, which is proving to reduce health care spending, prevent antibiotic resistance and, most importantly, save lives,” said Michael McGarrity, president and CEO of Nanosphere. “Continued menu expansion with our [gram-negative blood culture] and enteric tests will provide additional value to our customers and patients and serve as the basis for our continued growth as a company.”