Gram-Negative Blood Culture Test Approved By FDA

By Cyndi Root

Nanosphere, Inc. has received clearance from the Food and Drug Administration (FDA) for its Verigene Gram-Negative Blood Culture (BC-GN) test. Nanosphere's President and Chief Executive Officer Michael McGarrity said, "We continue to see growing demand for our infectious disease tests, particularly our Gram-Positive Blood Culture (BC-GP) Test which is proving to reduce healthcare spending, prevent antibiotic resistance, and most importantly, save lives.” The company also submitted to the FDA its Verigene Enteric Pathogens Test. McGarrity said the two tests provide value to customers and form the foundation for continued company growth.

Gram-Negative Blood Culture Test

The Verigene BC-GN test has received approval by the FDA. It is a rapid test and identifies the family of gram-negative bacteria. These bacteria can cause infections in the bloodstream. The test also determines resistance to antibiotics and does so two or three days faster than current methods. When people contract bloodstream infections, complications result in sepsis and death. Sepsis and sepsis deaths cost the healthcare system over 20 billion dollars annually.

Infections marked by antibiotic resistance incur greater fatalities. The new test identifies genetic markers of antibiotic resistance. Of particular interest are the five genes that identify Carbapenem-resistant Enterobacteriaceae (CRE), a robust "superbug" resistant to antibiotics. The Center for Disease Control (CDC) has assigned an urgent hazard level to CRE, indicating a serious threat and a call for aggressive action.

Verigene Enteric Pathogens Test

Nanosphere has submitted its Verigene Enteric Pathogens Test to the FDA for approval. The test is for gastrointestinal infections. The company intends to market it to hospitals to diagnose community-acquired diarrhea. This condition usually results when people consume contaminated water or food. Contaminants include parasites, viruses, and bacteria.

While most cases of community-acquired diarrhea resolve themselves and do not involve the loss of life, the healthcare system is overburdened with cases. Nanosphere says that the condition causes four million emergency room visits and over a million inpatient hospitalizations. Physicians often rely on anecdotal evidence to make a diagnosis. Doctors ask patients about recent travel, visits to the zoo, consumption of unsafe food, and swimming in lakes, for example. Since symptoms and questioning the patient are often inadequate and time is of the essence to provide proper care, quick diagnosis by testing is preferred.

Source:
http://www.nanosphere.us/investors/press-releases