The Food and Drug Administration (FDA) has issued draft guidance providing recommendations on testing in vitro diagnostic devices for biotin interference. This draft guidance follows a 2017 safety communication in which FDA reported that taking high levels of biotin could interfere with lab tests that use this compound to bind target proteins, such as tests for hormones and cardiac markers. The 2017 safety communication provided recommendations for patients, healthcare professionals, and laboratory personnel on how to mitigate potential biotin interference. Now, this new draft guidance provides additional recommendations for in vitro diagnostic device manufacturers on how to test for biotin interference on in vitro diagnostic devices that use biotin technology. The guidance also outlines best practices for communicating the results of biotin interference testing to the end-users of diagnostic devices such as laboratory personnel.
Moving forward, FDA plans to work with researchers and healthcare professionals to improve understanding of how biotin interferes with laboratory tests. The agency also intends to advise diagnostic manufacturers as they develop tests that use biotin technologies to ensure that these tests bear minimal risk of biotin interference.
Nemaura’s Noninvasive Continuous Glucose Monitor Receives CE Mark
The CE mark has been granted to Nemaura Medical for SugarBeat, a needle-free continuous glucose monitor that consists of a disposable adhesive skin-patch connected to a rechargeable transmitter. This device provides real-time, continuous glucose readings at 5-minute intervals, which accumulate to provide users with a so-called ambulatory glucose profile. Users can then overlay these glucose profiles across multiple days to observe trends, patterns, and the extent of their glucose fluctuations. Nemaura believes that individuals with type 2 diabetes could use this in place of traditional periodic HbA1c readings to manage their glucose levels. Other features of SugarBeat include a visual alert that indicates when glucose levels are falling or rising above minimum and maximum thresholds, and an audible alert or physical vibration that SugarBeat sends through a user’s phone when glucose levels fall below dangerously low levels. Additionally, users have the option to wear the SugarBeat patch on non-consecutive days.
FDA Clears iCubate iC-GN Assay for the Detection of Bloodstream Infections
iCubate has obtained Food and Drug Administration (FDA) clearance for the iC-GN assay, a qualitative test that is designed to help decrease the burden of bloodstream infections and subsequent sepsis among critically ill patients. By detecting specific DNA targets, the iC-GN assay identifies gram-negative organisms associated with gram negative bacteremia, including Acinetobacter baumannii complex, Escherichia coli, and Klebsiella pneumoniae. The test also detects gene markers that indicate antibiotic resistance, including KPC and NDM, which are associated with resistance to carbapenems. The iC-GN will complement iCubate’s previously cleared iC-GPC assay, which identifies five of the most common gram-positive organisms associated with gram-positive bacteremia, including Staphylococcus aureus. The iC-GPC also identifies clinically relevant antibiotic resistance markers specific to methicillin-resistant Staphylococcus and vancomycin-resistant Enterococcus. Both tests run on iCubate’s multiplex polymerase chain reaction molecular diagnostics platform.
SpeeDx Gets OK From Health Canada for Antibiotic-Resistant STI Test
Health Canada has cleared SpeeDx’s ResistancePlus MG test for distribution across all Canadian provinces. This is the first molecular diagnostic test in Canada that detects sexually transmitted infection caused by Mycoplasma genitalium, along with genetic markers linked to antibiotic resistance. Resistance to azithromycin, a common macrolide antibiotic treatment for M. genitalium, has been increasing in areas where healthcare providers use M. genitalium detection alone to guide treatment. ResistancePlus MG could help to reverse this trend, and new evidence indicates that when providers use this test as part of a resistance-guided therapy protocol, cure rates for M. genitalium infection improve, rising from 60% to higher than 92%. The test is already in use across Europe, the United Kingdom, Australia, and New Zealand. While the Food and Drug Administration (FDA) has not yet cleared a test for the combined detection of M. genitalium and macrolide resistance markers, SpeeDx is also finalizing clinical trials in the U.S. in preparation for FDA submission later this year.
Akonni Biosystems Gets FDA Nod for Multiplex Molecular Testing Platform
The Food and Drug Administration (FDA) has granted 510(k) clearance to Akonni Biosystems for the TruDiagnosis system, a multiplex molecular diagnostic device designed for point-of-care use. The system includes the TruDx 2000 Imager and the TruArray consumable test kit, the latter of which features gel-drop microarray technology and a novel microfluidic design that integrates on-chip polymerase chain reaction with one to hundreds of microsensors in a single chamber. The system delivers results in 15 minutes for immunoassays, and in 1-3 hours for nucleic acid-based tests. The first assay cleared for use on this platform is a saliva test that identifies genetic signatures associated with patient metabolization of the blood-thinning drug Coumadin, and that is intended to help doctors adjust a patient’s therapeutic Coumadin dose to safer and more effective levels. Following this FDA clearance, Akonni plans to partner with other diagnostic companies to develop additional diagnostic assays for use on the TruDiagnosis system.
FDA Approves Abbott’s Alinity s Blood and Plasma Screening System
Abbott has received Food and Drug Administration (FDA) approval for the Alinity s System, which is designed to screen blood and plasma more efficiently and within a smaller space than currently available systems. The Alinity s System runs up to 600 tests per hour and is largely automated, with a minimum walk-away time of 3 hours. It gives blood donation centers the ability to track all activities and actions associated with blood and plasma donation and screening in accordance with regulatory requirements. The system also features solution bottles that work like a lock and key, meaning that they can only be inserted into the correction location on the instrument. Additionally, the Alinity s enables lab technicians to continuously load and unload samples and supplies without pausing or stopping the system, and features a software interface, menu, and sample loading layout that are all designed to be intuitive.