New Diagnostic Test to Detect the Methicillin-Resistant Staphylococcus Aureus Gets FDA’s Approval

A new diagnostic test has been developed using advanced technological tools to detect the Methicillin-resistant staphylococcus aureus (MRSA)bacterial colonization. MRSA is the most common cause of hospital-acquired infections. Authorized marketing of this new diagnostic test for MRSA is approved by the Food Drug and Administration (FDA) on Dec 5, 2019.

Click here to read the official press release from the FDA.

The Cobas vivoDx test helps the health care professionals for evaluating the patients with MRSA. It would be done by the colonization of bacterial culture which is an easy and quick method for diagnosis than the traditional techniques used for diagnostic testing.

Food and Drug Administration (FDA) is an agency in the U.S. Department of health and human services. The goal of this agency is to protect the public health. This would be done by ensuring the effectiveness, safety and security of veterinary and human medication, drug and medical equipment, vaccines, and other biological products that human uses for treatment and other purposes. The security of national food, dietary supplements, cosmetics, electronic radiation products, and tobacco products is also regulated by the FDA.

Tim Stenzel, director at “In Vitro Diagnostic and Radiological Health” in the FDA’s “Center for Devices and Radiological Health” shares that FDA aims to support the emerging and existing challenges to address the antimicrobial resistance. This is to protect the public against health complications and severe infections.

These innovative diagnostic tests help the health care professionals to quickly access to more accurate results about the infections to prevent the bacterial resistant from spreading. Today’s authorization proves to be the latest technique and tool for preventing and controlling the bacterial resistant in the high-risk environment.

Methicillin-resistant staphylococcus aureus (MRSA) is a bacterium that causes the hospital-acquired infection called nosocomial infections. Usually, the persons working in a hospital setup or the admitted patients acquired these types of infections. The infections can lead to serious illness and even death in more severe cases. According to the CDC, nearly 5% of the patients in the U.S. hospitals acquired MRSA bacterial infections.

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Many patients who carry the bacteria do not develop the infections in many cases as it is a serious antimicrobial-resistant threat to patients. If the persons get the infection, it is very difficult to treat this through antibiotics as the bacteria is highly resistant to many drugs. By using the active screening test for Methicillin-resistant staphylococcus aureus (MRSA) colonization, it is easy to reduce the level of MRSA infection by implementing the infection control measures. According to estimation by CDC, the of patients in the U.S. hospitals is more than 323,000 and 10,000 died in the year 2017.

New bacteriophage technology is used in the cobas viviDx MRSA which is based on bioluminescence. It detects the bacteria from the swab sample taken from nasal secretions. Then after 5 hours, the sample is compared to the already present cultural from 24-48 hours.

These diagnostic tests are helpful in the early detection of infections. It also helps health care professionals to prevent the spread of bacteria. A data reviewed from performance studies by the FDA for detecting bacteria accurately by the Cobas vivoDx MRSA in 90% samples. The Cobas vivoDx MRSA authorized tests are used in the prevention and control of infections in the hospital settings and correctly identified the patients with the infections.

Through the de novo premarket review pathway (it is a regulatory pathway for low to moderate risk detecting device), the Cobas vivoDx MRSA test is reviewed by the FDA. Besides this authorization, the special controls for preventing the infection are established by the FDA. This includes the following requirements such as labeling and design verification, validation to address certain risks e.g. false positives. It also maintains the special controls along with the general controls for ensuring the safety and effectiveness of this test.

Marketing authorization is granted by FDA for the COBAS vivoDx MRSA test to Roche Molecular Systems Inc.