AdvanDx, the Massachusetts-based molecular testing lab, has received approval from the U.S. Food and Drug Administration (FDA) for a test that would detect the presence of Staphylococcus aureus directly from blood samples. The FDA granted 510(k) clearance for the test, known as mecA XpressFISH. It can detect both methicillin-resistant and methicillin-susceptible strains of the bacteria (MRSA and MSSA). The test has a one-hour turnaround time. That’s dramatically quicker than coventional means of determining the presence of the bacteria, which requires culturing and can take up to 48 hours to obtain a result. “mecA XpressFISH detects and identifies expression of the gene, which will help clinicians determine if the infection is resistant to commonly used, well tolerated drugs,” said Geoffrey A. McKinley, AdvanDx’s senior vice president of research and development and business development. “The test will guide caregivers to the best course of antibiotic treatment, discontinuing the use of broad-spectrum antibiotics for patients with routine Staphylococcus aureus infections.” MRSA, which is also referred to as the “super bug,” has become a growing concern among health policy officials in the United States. Individuals commonly acquire such infections at health care facilities such as hospitals and dialysis centers, and the indiscriminate use of […]
AdvanDx, the Massachusetts-based molecular testing lab, has received approval from the U.S. Food and Drug Administration (FDA) for a test that would detect the presence of Staphylococcus aureus directly from blood samples.
The FDA granted 510(k) clearance for the test, known as mecA XpressFISH. It can detect both methicillin-resistant and methicillin-susceptible strains of the bacteria (MRSA and MSSA). The test has a one-hour turnaround time. That’s dramatically quicker than coventional means of determining the presence of the bacteria, which requires culturing and can take up to 48 hours to obtain a result.
“mecA XpressFISH detects and identifies expression of the gene, which will help clinicians determine if the infection is resistant to commonly used, well tolerated drugs,” said Geoffrey A. McKinley, AdvanDx’s senior vice president of research and development and business development. “The test will guide caregivers to the best course of antibiotic treatment, discontinuing the use of broad-spectrum antibiotics for patients with routine Staphylococcus aureus infections.”
MRSA, which is also referred to as the “super bug,” has become a growing concern among health policy officials in the United States. Individuals commonly acquire such infections at health care facilities such as hospitals and dialysis centers, and the indiscriminate use of antibiotics over the decades has made it more difficult to treat, making swift identification of the particular strain in each patient increasingly crucial.
About 100,000 cases of Staphylococcus aureus are diagnosed in the United States every year, killing about 11,000. Of those fatalities, about half are linked to the MRSA strain of the infection.
“Rapid results allow for the most appropriate anti-microbial therapy, which will improve patient outcomes and empower antibiotic stewardship programs,” said Thomas Davis, M.D., director of clinical microbiology at the Indiana University School of Medicine.
Takeaway: AdvanDx has brought to market a rapid MRSA test that could cut down on the outbreak of infections in the United States.
