Fingerprick-Free Glucose Monitor Gets CE Mark for Kids, Teens
Abbott has obtained the CE mark for the FreeStyle Libre flash glucose monitoring system indicated for children and teens with diabetes ages 4–17 years. This system eliminates the need for routine fingerpricks to monitor blood glucose levels. The FreeStyle Libre flash glucose monitoring system, which is already available in several European countries, reads glucose levels through a sensor that is worn on the back of the upper arm. It measures glucose every minute in interstitial fluid through a small filament that is inserted just under the skin and held in place with a small adhesive pad. A handheld reader is scanned over the sensor to get a glucose result in less than 1 second.
A recent accuracy study demonstrated that in children and teens ages 4–17 years, the FreeStyle Libre’s results are accurate, stable, and consistent for up to 14 days without fingerprick calibration. This is a key differentiator from current continuous glucose monitoring systems, which require more frequent fingerprick calibration. More than 97% of the children and teens participating in the study said that the FreeStyle Libre system is easier to use than fingerprick testing. The FreeStyle Libre system also enables the parents or caregivers of a child with diabetes to check night-time glucose levels without disturbing the child’s sleep. In addition to receiving the CE mark for use in children and teens, the FreeStyle Libre has been approved by Australia’s Therapeutic Goods Administration for insulin-using adults with diabetes ages 18 years or older.
NY State Authorizes Use of Test for Resolving Ambiguous Lung Cancer Diagnoses
Veracyte has received regulatory authorization from the New York State Department of Health to offer the Percepta Bronchial Genomic Classifier for patients in the state. This 23-gene test is intended to help patients avoid the invasive procedures typically needed to assess potentially cancerous lung nodules detected by computerized tomography (CT) scans. Lung nodules found on CT scans are often difficult to diagnose without a biopsy. Bronchoscopy provides a less invasive alternative, but approximately 40% of patients who undergo bronchoscopy still receive ambiguous results. Following an inconclusive bronchoscopy, the Percepta Bronchial Genomic Classifier uses proprietary technology to identify patients with lung nodules or lesions who are at low risk of cancer. These patients can then be monitored with CT scans rather than undergoing an invasive confirmatory procedure. The test’s performance has been demonstrated in prospective, multicenter studies, the results of which were published in The New England Journal of Medicine.
BD Earns 510(k) Clearance for Flow Cytometry System for HIV/AIDS Testing
BD has received Food and Drug Administration (FDA) clearance for its BD FACSPresto system and BD FACSPresto CD4/Hb Cartridge for the management of HIV/AIDS patients. The BD FACSPresto system is an automated multicolor fluorescent imaging cytometer and absorbance spectrometer that provides absolute and percentage results of CD4 T lymphocytes and hemoglobin (Hb) concentration in whole blood samples. It weighs 6 kg and uses a proprietary dried reagents cartridge to offer increased stability across a wide range of storage conditions. The system includes a touchscreen, language-independent user interface, and is able to process up to 80 tests in a day. After fingerstick or venipuncture blood collection, the sample can be transferred and incubated on a single-use disposable cartridge with results available in less than 4 minutes. Results from clinical studies demonstrate that the BD FACSPresto system performs comparably with traditional analyzers, including the BD FACSCalibur system.