CLN - Regulatory Roundup

PerkinElmer Gets FDA Nod for Lupus Test

Regulatory Roundup: August 2018

The Food and Drug Administration has granted 510(k) clearance to PerkinElmer for its Euroimmun Crithidia luciliae immunofluorescence test (CLIFT) and CLIFT sensitive assays. CLIFT testing supports the detection of anti-double stranded DNA (anti-dsDNA), which is one of the exclusive markers for systemic lupus erythematosus and has a prevalence of 40%-90% in lupus patients. While other immunologic tests such as enzyme-linked immunosorbent assay and radioimmunoassay detect anti-dsDNA antibodies, these methods historically provide sensitivities around 20%. The Euroimmun CLIFT sensitive assay—performed on the fully automated EUROPattern microscope and software system—improves sensitivity by 30% compared with other serological tests, helping to minimize false negative results.

The EUROPattern microscope’s workflow renders digital images within 13 seconds per field and is designed to improve result turnaround time during the screening process. Euroimmun’s proprietary Biochip technology also reduces sample and reagent requirements. PerkinElmer acquired the German-based company Euroimmun in 2017 with the goal of expanding its reach into autoimmune and allergy diagnostic markets.

Medtronic Earns Expanded FDA Approval for Type 1 Diabetes Management Device

The Food and Drug Administration (FDA) has expanded the approval of Medtronic’s MiniMed 670G hybrid closed looped system diabetes management device to include individuals age 7 to 13 with type 1 diabetes. This device is intended to automatically monitor blood glucose levels and provide appropriate basal insulin doses with little or no input from the user. FDA originally approved it in September 2017 for use in patients 14 years of age or older with type 1 diabetes. The MiniMed 670G hybrid closed looped system works by measuring glucose levels in the body every 5 minutes and automatically adjusting insulin, except to counter carbohydrate consumption at mealtime, at which point users need to manually request insulin doses. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin.

FDA OKs First Continuous Glucose Monitoring System With Fully Implantable Sensor

Senseonics has received Food and Drug Administration (FDA) approval for the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age or older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose. The system’s small sensor is implanted just under the skin by a qualified healthcare provider during an outpatient procedure. Afterward, the sensor regularly measures glucose levels for up to 90 days, sending information to a mobile app every 5 minutes to alert users if glucose levels are too high or low. The implanted sensor uses a novel light-based technology to determine glucose levels: a fluorescent chemical coating on the sensor that, when exposed to blood sugar, produces a small amount of light that the sensor measures.

FDA Approves Two Grifols Tests for Screening Blood Donations

Grifols has received Food and Drug Administration approval for two blood screening assays: Procleix Ultrio Elite and Procleix WNV. Procleix Ultrio Elite is an assay designed to increase blood safety by screening and delivering simultaneous results for HIV type 1, hepatitis C virus, and hepatitis B virus, while also detecting HIV type 2. This assay tests pools of plasma composed of up to 96 individual donations from donors of source plasma.

The Procleix WNV assay is a qualitative nucleic acid assay for the detection of West Nile virus RNA in the plasma and serum of human blood donors. Both assays run on Grifols’ nucleic acid testing (NAT) blood screening platform, the Procleix Panther system.

China FDA Grants Approval to Vela Diagnostics for cfDNA Extraction Kit

Vela Diagnostics has received approval from the China Food and Drug Administration for the Sentosa SX cell-free DNA (cfDNA) kit, which is intended to extract cfDNA from human plasma for liquid biopsies and can be used in real-time polymerase chain reaction (PCR) and next-generation sequencing (NGS) workflows. Besides displaying a high recovery efficiency of circulating cfDNA with fragment size of approximately 170 base pairs, the extraction kit is also able to recover low frequency DNA variants in blood, even at a 5% mutation rate.