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For four previously cleared Lyme disease tests, the Food and Drug Administration (FDA) has cleared new indications that may help streamline diagnosis of this condition. The tests are made by Zeus Scientific and include the Zeus ELISA Borrelia VlsE1/pepC10 IgG/IgM test system, Zeus ELISA Borrelia burgdorferi IgG/IgM test system, Zeus ELISA Borrelia burgdorferi IgM test system, and the Zeus ELISA Borrelia burgdorferi IgG test system.
Traditionally, laboratories have diagnosed Lyme disease through a two-tier process that confirms the presence of antibodies to Borrelia burgdorferi, the bacteria that causes this condition. This standard two-tier process involves performing an enzyme immunoassay (EIA) on a patient blood sample followed by an immunoblot or Western blot. Due to the complexity of immunoblots, however, labs often need to send these tests out to reference labs, leading to longer turnaround times. The interpretation of immunoblot results is also subjective. Zeus Scientific’s tests aim to remedy these issues by enabling labs to use a modified two-tier approach in which two EIAs are run concurrently or sequentially, eliminating the need for an immunoblot. After reviewing clinical data on Zeus Scientific’s tests, FDA found that this alternative approach to Lyme disease testing detects Borrelia burgdorferi antibodies as accurately as traditional two-tier methods.
FDA OKS MOLECULAR POC TESTING PLATFORM FOR CHLAMYDIA, GONORRHEA
Binx Health has received 510(k) clearance from the Food and Drug Administration for its fully automated, molecular point-of-care (POC) diagnostic testing platform, the binx io. The platform detects the bacteria that cause chlamydia and gonorrhea in female vaginal swab samples, and provides results in about 30 minutes. Binx validated the binx io in a 1,523-person, multi-center clinical study that compared the platform to current central lab standard of care systems for diagnosing these two sexually transmitted infections. During the study, non-laboratorians processed 96% of patient samples on the binx io in a POC setting. Results showed that the platform exhibits 96.1% sensitivity and 99.1% specificity for chlamydia and 100% sensitivity and 99.9% specificity for gonorrhea. The platform consists of a small benchtop instrument and single-use, assay-specific cartridges. The cartridges contain all reagents needed for the assay and use polymerase chain reaction amplification and Binx’s proprietary electrochemical detection technology.
DRAWBRIDGE HEALTH RECEIVES FDA CLEARANCE FOR HBA1C TEST SYSTEM
The Food and Drug Administration has granted 510(k) clearance to Drawbridge Health for the OneDraw A1c test system, which comprises the OneDraw Blood Collection Device and the OneDraw A1c test. Healthcare providers can use this system to collect and stabilize blood samples and measure HbA1c levels in order to monitor the long-term control of blood glucose in individuals with diabetes. The system uses the OneDraw Blood Collection Device, a small single-use device that draws a capillary blood sample from the upper arm. Healthcare providers place the device on the skin, where it collects blood using tiny lancets with light vacuum suction, followed by stabilization of the blood sample within a removable cartridge. The lab then performs the OneDraw A1c test on the sample. Clinical study results indicate a strong correlation between the HbA1c measurements obtained from samples collected using the OneDraw Blood Collection Device and those collected using venipuncture or fingerstick.
QIAGEN RECALLS FILTER TIPS DUE TO RISK OF LEAKAGE
Qiagen has issued a recall for its pipetting system filter tips that are intended for use with the QIAsymphony SP/AS instruments. The recall is due to a manufacturing malfunction that resulted in defective filter tips with internal abrasions. Users of these defective tips have reported splashes on the QIAsymphony instrument, liquid in the tip guard, leaking tips, failed test signals, empty wells indicative of volume loss, and incorrect test results. Due to the risk of inaccurate test results, the Food and Drug Administration (FDA) has identified this as a Class I recall, which means that using these filter tips may cause serious injuries or death. The two FDA approved/cleared assays that use these filter tips are the Qiagen Artus CMV QS-RGQ MDx, which aids in monitoring antiviral treatment for cytomegalovirus, and the Qiagen ipsogen JAK2 RGQ PCR, which aids in the evaluation of patients for myeloproliferative neoplasms. Moving forward, Qiagen recommends that customers stop using identified lots of the defective filter tips and also urges labs to review results obtained on QIAsymphony SP/AS instruments when the affected tips were in use.
NEW YORK STATE APPROVES ADAPTIVE BIOTECHNOLOGIES’ CLONOSEQ ASSAY
Adaptive Biotechnologies has received approval from the State of New York Clinical Laboratory Evaluation Program (CLEP) for the clonoSEQ assay. By analyzing DNA extracted from bone marrow, blood, or archived tissues samples, this assay detects and monitors minimal residual disease (MRD) in patients with B-cell blood cancers. Additionally, clonoSEQ is the first Food and Drug Administration (FDA)-authorized test for MRD assessment in bone marrow samples from patients with B-cell acute lymphoblastic leukemia and multiple myeloma. Other B-cell blood cancers that this test detects and monitors include chronic lymphocytic leukemia and B-cell non-Hodgkin’s lymphoma. The clonoSEQ assay uses Adaptive Biotechnologies’ immunosequencing platform to identify and quantify the following DNA sequences found in malignant cells: rearranged IgH (VDJ), IgH (DJ), IgK, and IgL receptor gene sequences, as well as translocated BCL1/IgH (J) and BCL2/IgH (J) sequences. The test previously received FDA authorization through the agency’s de novo regulatory pathway, and with CLEP approval, it is now available in all 50 states.
NEUMODX GETS CE MARK FOR CYTOMEGALOVIRUS, EPSTEIN-BARR VIRUS TESTS
The CE mark has been granted to NeuMoDx Molecular for two new tests for cytomegalovirus (CMV) and Epstein-Barr virus (EBV). These tests are intended for monitoring solid organ transplant recipients for CMV and EBV infection and identifying patients who need medication to prevent or treat post-transplant complications caused by these viruses. The tests run on NeuMoDx’s molecular systems, which are a family of scalable platforms that integrate the molecular diagnostic process from sample to result. These fully automated analyzers provide results in approximately 1 hour and feature a continuous, random-access workflow, as well as an operator walkaway window of up to 8 hours. NeuMoDx’s molecular systems also use NeuDry reagent technology, which integrates magnetic particle affinity capture and real-time polymerase chain reaction chemistry in a multi-sample microfluidic cartridge. These reagents require no refrigeration, have an on-board stability of up to 60 days, and an ambient temperature shelf life of longer than 1 year.