Diagnostic Test for Ebola virus Is Allowed by FDA

Diagnostic Test for Ebola virus Is Allowed by FDA

Recently, the U.S. Food and Drug Administration allowed the marketing of a rapid diagnostic test (RDT) that helps to detect the Ebola virus antigens (proteins) in human blood from certain living individuals & samples (cadaveric oral fluid) from certain recently deceased individuals suspected to have died from Ebola. The OraQuick Ebola Test is the first-ever rapid diagnostic test that is allowed by the FDA has to be marketed in the U.S. for the Ebola Virus Disease (EVD)detection. The OraQuick Ebola Test provides a rapid, presumptive diagnosis that must be confirmed.

Ned Sharpless, the acting FDA Commissioner , M.D, said that today’s marketing authorization provides another important tool in the effort to fight against Ebola, which continues to be a priority of the U.S. Government, especially as they work with their partners, including the WHO, to help address the current Ebola outbreaks in the Democratic Republic of Congo. He added that the current outbreak in the Democratic Republic of Congo has already killed thousands & the outbreak in West Africa which began in the year 2014 tragically killed more than 11,000. Investigational vaccines& therapeutics have shown promising results, but one of the most important tools in stopping these outbreaks is quickly diagnosing patients & supporting safe and dignified burials. Marketing authorization may actually provide additional assurances to the health care professionals seeking to use these types of rapid diagnostics and tests. The ability to use the Ebola virus antigen test to promptly make a presumptive Ebola diagnosis could help providers to more quickly isolate patients & begin treatments that can be potentially life-saving. And additionally, this device could be used to support safe & dignified burials while helping to reduce the risks of transmission during those burials.

Ebola Virus Disease, which is caused by the Ebola virus, is a severe, often fatal disease in humans. This can spread through direct contact with blood/body fluids or objects contaminated with the body fluids, and also from the bodies of those who have actually died from the Ebola virus infection. Ebola Virus Disease has led to several large outbreaks in Africa, including the West African Ebola epidemic that began in the year 2014 and was the largest outbreak of Ebola Virus Disease in recorded history, & the ongoing outbreak in the DRC, which is currently the second-largest outbreak. Extensive prevention efforts are underway by the Ministry of Health in the Democratic Republic of Congo to contain the current outbreak with supports from WHO, the U.S. government, & other partners. These prevention measures include campaigns to promote good hygiene, specialized Ebola infection treatment centers where those infected or those who exposed to the virus can receive investigational therapeutics, large-scale vaccination campaigns, and comprehensive efforts to trace & prevent the spread of EVD through vaccination campaigns, monitoring for symptoms, diagnostic testing, and implementation of infection prevention & control measures, such as safe and dignified burial procedures.

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During the 2014 Ebola outbreak, the Secretary of the Department of Health & Human Services had declared that circumstances exist justifying the authorization of certain emergency use of in-vitro diagnostics for the detection of the Ebola virus. At the same time, the FDA worked with CDC & test developers to make diagnostic tests, including the OraQuick Ebola Rapid Antigen Test, available through the Emergency Use Authorization (EUA) pathway. This EUA pathway allows the Food and Drug Administration to temporarily authorize the use of unapproved medical products for addressing a public health emergency when specific conditions are met, including that there are no adequate, approved & available alternatives to the product for diagnosing, preventing, or treating the disease/condition. FDA has authorized many diagnostic tests for EVD under this pathway to assist with the public health responses. Today’s marketing authorization of the first Emergency Use Authorization pathway presumptive rapid diagnostic test for Ebola virus antigens through the De-Novo review pathway reflects the ongoing collaboration between the U.S. Government & test developers to gather additional data on Emergency Use Authorization pathway products.

For the OraQuick Ebola Test submission, the Food and Drug Administration reviewed data from multiple clinical studies of blood samples & cadaveric oral fluid from the 2014 West African outbreak and from a variety of analytical studies. Based on these data, the Food and Drug Administration determined that general & special controls were necessary to provide a reasonable assurance of the safety & effectiveness of the OraQuick Ebola Tests when intended to identify antigens associated with the Ebola virus infection in blood from symptomatic patients & oral fluid of cadavers. Amount of Ebola virus when the patients have severe symptoms of Emergency Use Authorization pathway is usually high; however, the amount of Ebola virus in samples taken early after infection when symptoms aren’t present yet/taken early during the course of Emergency Use Authorization pathway when symptoms are mild can be very low. The recent studies demonstrated the importance of testing only symptomatic individuals so that the amount of Ebola virus is high enough to be detectable by this Ebola test. OraQuick Ebola Test is for use in patients suspected of & with signs/symptoms consistent with EVD, and when a patient meets the CDC’s Ebola virus epidemiological criteria. OraQuick Test is not intended to be used for the general Ebola infection screening (e.g., airport screening) or the testing of individuals at risk of exposure without observable signs of infection.

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This recent test may also be used in recently deceased individuals (cadaveric oral fluid) with epidemiological risk factors (including geographic locations with a high prevalence of EVD) suspected to have died of Emergency Use Authorization (EUA) pathway to inform decisions on the safe handling of cadavers to prevent the disease transmissions.

Negative results do not rule out the Ebola virus infection. The definitive identification of Ebola requires additional testing and also confirmation procedures, such as by a more sensitive but less rapid polymerase chain reactions test,& in consultation with public health and/or other authorities to whom reporting is required.

The recentEbola Test was reviewed under the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this marketing authorization, the Food and Drug Administration is establishing criteria, called the special controls, that helps to determine the requirements for demonstrating accuracy, reliability & also the effectiveness of tests intended to identify Ebola virus antigens. These special controls provide a reasonable assurance of safety & effectiveness for tests of this type. The action also creates a new regulatory classification. This means subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby the devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The Ebola Rapid Antigen Test was granted Breakthrough Device designation, meaning the Food and Drug Administration provided intensive interaction & guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. In order to qualify for such designation, a device must provide for more effective treatment/ diagnosis of a life-threatening or say irreversibly debilitating disease or condition & meet one of the following criteria. i.e, the device must represent a breakthrough technology and also there must be no approved. It should have cleared alternatives and the device must offer significant advantages over existing approved or cleared alternatives, or the availability of the devices is in the best interest of patients.

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The Food and Drug Administration granted marketing authorization of the Ebola Rapid Antigen Test to OraSure Technologies, Inc.

The Food and Drug Administration promotes & protects the public health by, among other things, assuring the safety, effectiveness & security of human and veterinary drugs, vaccines & other biological products for human uses, and the medical devices. Agency also is responsible for the safety& security of the nation’s food supply, cosmetics, dietary supplements, products that give off the electronic radiation, and for regulating tobacco products.


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