The Food and Drug Administration (FDA) has granted de novo authorization to OraSure Technologies to market the OraQuick Ebola rapid antigen test, making this the first FDA-authorized rapid diagnostic test that detects Ebola virus antigens in blood. The amount of Ebola virus can be very low in samples taken early after infection when symptoms are not present yet or very mild. Therefore, this test should only be used in individuals with signs and symptoms consistent with Ebola virus disease (EVD) to ensure that the amount of virus in a sample is high enough to be detected. The OraQuick Ebola rapid antigen test is also intended for use with cadaveric oral fluid from recently deceased individuals suspected to have died from EVD, and can be used to inform decisions on safe handling of cadavers to prevent disease transmission. The test provides a presumptive diagnosis, which means that labs must confirm its results with additional testing, such as with a more sensitive polymerase chain reaction test.
FDA originally granted emergency use authorization for the OraQuick Ebola test in 2014, so that healthcare workers could use it during the Ebola outbreak in West Africa that year. Before granting this new marketing authorization for the test, the agency reviewed data from multiple clinical studies of the test’s performance with blood and cadaveric oral fluid samples from the 2014 West African outbreak, as well as data from a variety of analytical studies on the test.
FDA Warns of Cybersecurity Issues That Could Affect Medical Devices
The Food and Drug Administration (FDA) has issued a statement informing healthcare professionals, information technology staff in healthcare facilities, manufacturers, and patients about a set of cybersecurity vulnerabilities, referred to as URGENT/11, that could impact medical devices and hospital networks. URGENT/11 affects several operating systems that may then impact certain medical devices connected to a communications network, such as Wi-Fi and public or home internet, as well as other connected equipment such as routers and smartphones. These cybersecurity vulnerabilities could allow a remote user to take control of a medical device and change its function, cause denial of service, or cause information leaks or logical flaws, all of which could prevent a device from functioning properly or at all. To date, FDA has not received any adverse event reports associated with these vulnerabilities, but it is asking manufacturers to work with healthcare providers to determine which medical devices, either in their healthcare facility or used by their patients, could be affected by URGENT/11 and to develop risk mitigation plans.
Dexcom Gets FDA Nod for New Continuous Glucose Monitoring System
The Food and Drug Administration (FDA) has cleared the Dexcom G6 Pro Continuous Glucose Monitoring (CGM) system for healthcare professionals to use with patients who are ages 2 years and older. Dexcom G6 Pro is the first FDA-authorized professional CGM that gathers real-time glucose data over a 10-day period and offers both a blinded and unblinded mode. In blinded mode, the system hides real-time glucose data from patients so that a healthcare professional can review it retrospectively at the end of the session and assess patient glycemic variability. In unblinded mode, patients can see their glucose data throughout the 10-day sensor wear to gain insights and make treatment decisions in real time. In addition to these two modes, the Dexcom G6 Pro CGM system also features a single-use, disposable sensor, as well as alerts and alarms that in unblinded mode warn users of dangerously high and low glucose levels.
FDA Clears Fujirebio’s Whole Parathyroid Hormone Test
Fujirebio Diagnostics has received Food and Drug Administration clearance for the company’s Lumipulse G whole parathyroid hormone (PTH) assay, which is designed to run on the Lumipulse G1200 immunoassay platform. This test is intended for use in the differential diagnosis of hypercalcemia and hypocalcemia resulting from calcium metabolism disorders. Studies have demonstrated that the Lumipulse G whole PTH performs with high precision, with a coefficient of variation less than or equal to 4%. Compared with intact PTH assays, it has no detectable cross reactivity with 7-84 and other PTH fragments, because it only measures biologically active PTH and is therefore 100% specific to whole PTH. The test is also traceable to in-house calibrators that have been assigned to the World Health Organization’s standard. In addition, the assay is fully automated with a reaction time of 30 minutes and uses a single-test cartridge design.
CE Mark Granted to BioGX for Enhanced Flu, RSV Test
BioGX has earned the CE mark for its new Flu A, Flu B, RSV A/B automated test. This test is a multiplex real-time reverse transcription polymerase chain reaction (PCR) assay that qualitatively detects RNA specific to influenza A and B, and to respiratory syncytial virus (RSV) A and B. It is designed to run on the BD Max system made by BD, and is intended for use with nasal wash, pharyngeal swab, and nasopharyngeal swab collections obtained from individuals at risk for respiratory viral infections. This new test expands the strain coverage and improves on the detection sensitivity of BioGX’s previously released test for influenza and RSV, and it also offers testing for a greater variety of specimen types. As with all BioGX tests, it is offered in a sample-ready format in which all real-time PCR reagents are lyophilized in a single tube. BioGX plans to work with distributors and customers to gradually transition users of its current Flu A, Flu B, RSV A/B test to this upgraded version.