As part of the Food and Drug Administration’s (FDA) efforts to deal with the opioid crisis, the agency launched an innovation challenge on May 31, 2018, to spur the development of medical devices, including diagnostic tests, that could help prevent and treat opioid use disorder. The innovation challenge’s call for applications drew more than 250 submissions from medical device developers. From this pool, FDA has now selected eight challenge participants who will work directly with the agency to accelerate the development and marketing application review of their products. Two of the challenge participants are working on diagnostic tests: The company Milliman is developing a test intended to predict the risk of opioid use disorder called Opioid Prediction Service, while Algomet Rx submitted a test for opioid use monitoring called Rapid Drug Screen. As part of the challenge’s next steps, FDA and these companies will collaborate to define the patient and user needs for these devices, as well as the important risks and benefits, and will discuss the potential regulatory pathways going forward.
Meridian Bioscience Receives FDA Authorization for Newborn CMV Test
The Food and Drug Administration (FDA) has granted Meridian Bioscience marketing authorization for the Alethia CMV assay test system, making this the first FDA-authorized test designed to aid in diagnosing cytomegalovirus (CMV) infection in newborns less than 21 days of age. The Alethia test detects CMV DNA from a saliva swab. Data from a prospective clinical study involving 1,483 saliva samples collected from newborns showed that the test correctly identified 1,472 out of 1,475 samples as negative for the presence of CMV DNA and correctly identified five specimens as positive. The test incorrectly identified three samples as positive when they were negative. As part of FDA’s evaluation of the test, the agency also reviewed data from a study using 34 samples of archived specimens from babies known to be infected with CMV in which the Alethia correctly identified all specimens as positive. FDA reviewed the test through the de novo premarket review pathway.
PixCell Medical Gets FDA OK for Point-of-Care Hematology Analyzer
The Food and Drug Administration has cleared PixCell Medical’s HemoScreen, a miniature portable hematology analyzer that uses disposable cartridges to perform a complete blood count (CBC). Each cartridge the device uses includes all necessary reagents and is designed to work with a drop of blood collected via fingerstick. According to PixCell, operation of the device requires minimal training and expertise, and also does not necessitate maintenance or calibration. Once a cartridge is inserted into the reader, the blood sample is automatically processed, with the HemoScreen analyzing 20 standard CBC parameters within 5 minutes, including red blood cell (RBC) count, RBC indices, absolute white blood cell (WBC) count, and WBC 5-part differential, as well as hemoglobin and platelet parameters. The device employs patented technology based on microfluidics, machine vision, and artificial intelligence. It also uses imaging flow cytometry, which involves flow focusing cells into a single-layer plane within a microfluidic chamber and then analyzing their images.
FDA Grants Emergency Use Authorization for Fingerstick Ebola Test
Chembio Diagnostic Systems has received emergency use authorization (EUA) from the Food and Drug Administration for a rapid, single-use test for the Ebola virus that is intended for use in locations where healthcare providers do not have access to standard nucleic acid tests. This is the second Ebola rapid antigen fingerstick test made available under EUA, and the first that uses a portable battery-operated reader, which is designed to help provide clear diagnostic results outside of the lab. The test, called the DPP Ebola Antigen system, is intended for use with blood specimens from individuals with signs and symptoms of Ebola virus disease in addition to other risk factors, such as living in an area with a large number of Ebola cases and/or having contact with other individuals exhibiting signs and symptoms of Ebola virus disease. Specifically, the test is authorized for use with capillary fingerstick whole blood, EDTA venous whole blood, and EDTA plasma.
Certain Test Strips for Roche’s CoaguChek May Provide Inaccurate Results, FDA Warns
The Food and Drug Administration (FDA) has issued a warning that, when used with certain test strips, Roche Diagnostics’ point-of-care CoaguChek test meter devices may provide inaccurate results and should not be relied upon to adjust warfarin dosages. This warning comes in the wake of Roche issuing a voluntary recall of more than 1.1 million packages of CoaguChek XS PT test strips that were distributed nationwide between January 12 and October 29, 2018. Medical device reports submitted by Roche to FDA indicate that the test strips may provide an international normalized ratio result that is higher than the true value. Roche attributed this problem to the fact that the company recalibrated the test strips to a different international standard earlier in 2018. To remedy this issue, Roche recalibrated the test strips again and as of October 29, 2018, began shipping new, FDA-reviewed batches of the strips to healthcare and patient self-testing service providers.
FDA Draft Guidance Updates Recommendations for Blood Glucose Monitors
The Food and Drug Administration (FDA) has released two new draft documents intended to guide manufacturers preparing 510(k) submissions for blood glucose monitoring test systems: “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” and “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.” When finalized, these documents will replace the two guidance documents issued under the same titles in 2016. This new draft guidance provides FDA’s updated recommendations regarding the studies and information that manufacturers should use when submitting premarket notifications for blood glucose monitors intended for use by healthcare professionals in clinical settings, as well as for monitors intended for use by diabetes patients as an aid in managing their condition. The agency is seeking comments on both draft documents until February 28, 2019. Comments may be submitted at www.regulations.gov.