FDA Clears First Test to Assess Risk of Developing Acute Kidney Injury
Astute Medical has received Food and Drug Administration (FDA) clearance for the NephroCheck test, the first laboratory test designed to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) within 12 hours. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death.
AKI is a sudden decline in kidney function that often occurs without early signs or symptoms, and that follows an injury to the kidney caused by a co-existing disease, infection, or other condition. AKI can cause fluid to build up in the body, chest pain, muscle weakness, and permanent kidney damage or chronic kidney disease. Critically ill patients are at the highest risk for AKI, particularly if they are older, diabetic, or have high blood pressure.
Current laboratory tests can only assess whether a patient may already have AKI, and often, the patient has progressed to moderate or severe AKI before the test results confirm the clinical diagnosis. NephroCheck can help catch AKI before it worsens by detecting in urine two biomarkers associated with acute kidney injury: insulin-like growth factor binding protein 7 and tissue inhibitor of metalloproteinases. Within 20 minutes, the test provides a score based on the amount of these proteins present that correlates to the patient’s risk of developing AKI within 12 hours of the test being performed.
FDA’s review of the test included two clinical studies that compared the clinical diagnoses of more than 500 critically ill subjects at 23 hospitals to NephroCheck test results. NephroCheck accurately detected 92% of AKI patients in one study and 76% in the other, though it should also be noted that in both studies, NephroCheck gave a false-positive result in about half of patients without AKI.
CE Mark Granted to Abbott’s Finger Prick-Free Glucose Monitoring System
Abbott has received the CE Mark for its FreeStyle Libre flash glucose monitoring system, a continuous glucose monitoring technology for patients with diabetes that eliminates the need for routine finger pricks. The FreeStyle Libre system is a water-resistant sensor about the size of a quarter that can be worn on the back of the upper arm for up to 14 days. It measures glucose every minute in interstitial fluid through a 5 mm long, 0.4 mm wide filament that is inserted just under the skin and held in place with a small adhesive pad. The patient can then get a glucose result in less than one second by scanning the sensor with a reader. Each scan displays a real-time glucose result, an 8-hour history, and the direction glucose levels are heading. Additionally, the reader holds up to 90 days of data, providing trends and patterns of glucose levels over time.
First Direct Blood Test for Five Yeast Pathogens Receives FDA Clearance
FDA has cleared T2 Biosystem’s T2Candida panel and T2Dx instrument, the first direct blood test for the detection of five common yeast pathogens that cause sepsis. These pathogens include Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata, and/or Candida krusei—all five of which may cause serious bloodstream infections in people with weakened immune systems, including patients undergoing cancer treatment, receiving immunosuppressive therapy following an organ transplant, or patients in intensive care units. Traditional methods of detecting yeast pathogens in the bloodstream can take up to 6 days, with even more time needed to identify the specific type of yeast present. In comparison, the T2Candida panel can identify these five yeast pathogens from a single blood specimen within 3 to 5 hours, enabling physicians to initiate anti-fungal treatment early. In clinical studies, T2Candida correctly identified the species of yeast in 84–96% of positive specimens.
FDA Clears Beckman Coulter’s Hematology Connected Workcell Solution
Beckman Coulter Diagnostics received 510(k) clearance from FDA for its UniCel DxH v3.0 software, which supports automated connectivity of the UniCel DxH 800 and DxH Slidemaker Stainer Coulter Cellular Analysis Systems. This clearance enables laboratories to use the UniCel DxH Connected Workcell solution to connect up to three DxH 800 analyzers to a DxH Slidemaker Stainer and create a customized, scalable workflow. Driven by Beckman Coulter’s Automated Intelligent Morphology technology—
a multidimensional, high-definition flow cytometric technology—the workcell’s bi-directional sample transport system automatically distributes samples between the analyzers, reducing potential delays in sample testing and the reporting of results.
Biocartis Receives CE Mark for MDx Platform, BRAF Oncogene Test
The CE Mark has been granted to Biocartis’s molecular diagnostics system, Idylla, and the platform’s first oncology assay, the Idylla BRAF Mutation test. Idylla is a fully automated, real-time PCR system designed to allow clinicians to initiate a new test at any given time, without the need for batching or for trained operators. The system’s turnaround time varies between 35 and 120 minutes, allowing laboratories to report same-day results. Additionally, Idylla’s multiplex capability can detect up to 30 molecular targets simultaneously in the same sample, enabling the system to handle complex assays. As for the BRAF Mutation Test, it is designed to determine the most appropriate treatment for a specific type of skin cancer that is driven by the BRAF oncogene. Unlike other BRAF tests, the assay can detect mutations directly from formalin-fixed, paraffin-embedded tissue slices in about 90 minutes.
Nova StatStrip Glucose Hospital Meter System Gets FDA Nod for Intensive Care Use
FDA has cleared Nova Biomedical’s StatStrip Glucose hospital meter system, making it the first and only blood glucose monitoring system to receive clearance for use throughout all hospital and professional healthcare settings, including intensive care settings.
The StatStrip Glucose is also CLIA-waived in all settings.
Nova met with FDA in 2010 to define the rigorous studies necessary to evaluate StatStrip Glucose in professional healthcare settings. The StatStrip Glucose’s performance was studied in 1,698 patients receiving intensive medical intervention. Patient data included 19 medical condition categories as designated by the World Health Organization, representing 257 different medical condition sub-categories, in which approximately 8,000 medications were administered to patients. For each major medical condition and drug class category, StatStrip Glucose was evaluated against several rigorous performance criteria, statistical analyses tools, and insulin dosing error risk assessment models used by medical professionals, standards organizations, and regulators. FDA found that the performance assessment tools, including the insulin dosing risk models, demonstrated that StatStrip Glucose has acceptable clinical performance within intensive care settings when testing is performed by healthcare professionals or point-of-care waived operators.