The Food and Drug Administration (FDA) has cleared Bio-Rad Laboratories’ QXDx BCR-ABL %IS kit and QXDx AutoDG ddPCR system for monitoring chronic myeloid leukemia (CML) patients’ molecular response to treatment. This test uses Bio-Rad’s droplet digital polymerase chain reaction (ddPCR) technology and is the first digital PCR test to receive FDA clearance for determining CML treatment response.
CML is managed with tyrosine kinase inhibitor (TKI) therapy, and the current standard method for monitoring patients’ TKI treatment response is reverse transcription quantitative PCR. However, this method can produce variable results, particularly when measuring low levels of the disease.
According to Bio-Rad, by using ddPCR, the QXDx BCR-ABL %IS kit enables more accurate monitoring of low levels of residual disease in patients with CML. ddPCR is a method for performing digital PCR that involves fractionating a sample into 20,000 droplets, then performing PCR amplification in each individual droplet.
This means that a single sample generates tens of thousands of data points rather than a single result, thereby maintaining the sensitivity and precision of digital PCR while lowering sample and reagent volume requirements and overall cost.
FDA, CDC, CMS to Improve Access to Diagnostics During Public Health Emergencies
The Food and Drug Administration (FDA), Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services have launched the Tri-Agency Task Force for Emergency Diagnostics with the aim of accelerating development and deployment of diagnostic tests during public health emergencies.
The agencies created this task force after receiving feedback from the clinical laboratory community that labs were uncertain about how to implement diagnostic tests that had received an Emergency Use Authorization (EUA) from FDA. Specifically, labs reported uncertainty about meeting CLIA regulations under an EUA.
The task force will work to define, refine, and streamline interagency approaches for the implementation of EUA diagnostic tests. It will also seek to fill other gaps in the federal government’s response to global health threats by providing a forum for each participating agency to coordinate and provide consultation.
Grifols Screening Test for Tick-Borne Pathogens in Donated Blood Gets FDA Approval
The Food and Drug Administration (FDA) has approved Grifols’ Procleix Babesia assay for screening blood donations for Babesia, a parasite transmitted to humans either through tick bites or donated blood from Babesia-infected individuals. This qualitative test detects ribosomal RNA from four Babesia species, B. microti, B. duncani, B. divergens, and B. venatorum, in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion.
The assay runs on the Procleix Panther system, a fully automated nucleic acid testing platform that also includes blood screening tests for HIV, hepatitis A, B, C, and E viruses, West Nile virus, and Zika virus. To evaluate the performance of this test, FDA reviewed data from a multi-center clinical trial conducted under an FDA Investigational New Drug study at the American Red Cross, Creative Testing Solutions, and the Rhode Island Blood Center (an affiliate of the New York Blood Center) in select areas of the U.S.
CE Mark Granted to HIV Test for Early Infant Diagnosis, Dried Blood Spot Testing
Hologic’s Aptima HIV-1 Quant Dx assay has received two new CE marks for early infant diagnosis and for testing an additional sample type, dried blood spots (DBS). This assay is an in vitro nucleic acid amplification test for the detection and quantitation of HIV type 1 (HIV-1) and runs on the fully automated Panther system. It is intended to aid in the diagnosis of HIV-1 infection, confirm HIV-1 infection, and as an aid in the clinical management of patients infected with this virus.
The assay can now be used to qualitatively detect HIV-1 RNA in infants younger than 18 months and to test DBS to monitor viral load and disease progression in HIV-1 infected individuals in European and African countries. The DBS claim is particularly important for HIV testing in African countries because DBS are more stable and easier to transport than liquid blood samples. This CE marking also makes Hologic’s test the first HIV-1 assay with a dual claim for both viral load and early infant diagnosis.
De Novo Designation Granted to Oxford Gene Technology’s Blood Cancer FISH Probes
Oxford Gene Technology has received de novo classification from the Food and Drug Administration for eight Cytocell Aquarius hematology fluorescence in situ hybridization (FISH) probes that detect chromosomal rearrangements in patients with acute myeloid leukemia and acute myelodysplastic syndromes. The probes included in this set are: AML1/ETO (RUNX1/RUNX1T1) translocation, dual fusion; CBFβ (CBFB)/MYH11 translocation, dual fusion; Del(5q) deletion; Del(7q) deletion; Del(20q) deletion; EVI1 (MECOM) breakapart; MLL (KMT2A) breakapart; and P53 (TP53) deletion.
These probes are designed for use with fixed bone marrow specimens consistent with World Health Organization guidelines for Classification of Tumors of Hematopoietic and Lymphoid Tissues and in conjunction with other clinicopathological criteria. Pre-mixed and ready-to-use, they are supplied as part of a complete kit including the fluorescent stain 4’,6-diamidino-2-phenylindole, detailed protocols, and signal pattern analysis guidelines.
Malaysia, Thailand Approve Hospitalized Pneumonia Test From Curetis, Acumen
Curetis and its partner Acumen Research Laboratories have received approval from the respective regulatory authorities in both Malaysia and Thailand to market the Unyvero HPN Hospitalized Pneumonia application cartridge, as well as approval from Thailand’s regulators for the Unyvero BCU Blood Culture application cartridge.
Within 4 to 5 hours, the Unyvero HPN and BCU tests detect a broad panel of pathogens and antibiotic resistance markers that are relevant for the diagnosis of hospitalized patients with suspected pneumonia and bloodstream infections, respectively.
With these new approvals, Unyvero HPN in particular is now fully registered as an in vitro diagnostic medical device in Singapore, Malaysia, and Thailand, a milestone that Curetis and Acumen hope will enable broader commercial roll out and adoption of this test throughout all member states in the Association of Southeast Asian Nations.