CLN - Regulatory Roundup

CE Mark Granted to Cepheid for Fingerstick HCV RNA Test

Regulatory Roundup: November 2018

Cepheid has received the CE mark for the Xpert HCV Viral Load Fingerstick (Xpert HCV VL FS), a molecular test that quantifies hepatitis C virus (HCV) RNA levels directly from a fingerstick blood sample. The test runs on Cepheid’s GeneXpert system and can be performed on both capillary whole blood and venous blood samples, detecting a wide range of HCV genotypes within 58 minutes. By developing a rapid RNA-based point-of-care test for HCV, Cepheid hopes to simplify the clinical care pathway for HCV, which currently involves complicated multi-step algorithms based on antibody screening followed by RNA confirmation. Cepheid collaborated with the Kirby Institute and Foundation for Innovation of New Diagnostics to evaluate the test’s accuracy. In a study of 223 participants, the Xpert HCV VL FS demonstrated 100% sensitivity and specificity for HCV RNA quantified from fingerstick samples when compared with an established venipuncture HCV assay.

Adaptive Biotechnologies Gets FDA Nod for Minimal Residual Disease Test

The Food and Drug Adminis-tration (FDA) has authorized Adaptive Biotechnologies to market its ClonoSEQ assay, a next-generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. The ClonoSEQ assay measures MRD by using multiplex polymerase chain reaction (PCR) and NGS to identify and quantify certain gene sequences in DNA extracted from patients. It detects MRD at levels below 1 in 1 million cells, making it more sensitive than current MRD tests based on PCR or flow cytometry that measure MRD down to 1 in 10,000 or 1 in 100,000 cells. FDA reviewed the ClonoSEQ assay through the de novo premarket review pathway and determined its clinical validity by performing a retrospective analysis of samples obtained from three previously conducted clinical studies including 273 patients with ALL, an ongoing study of 323 patients with multiple myeloma, and a study of 706 patients with multiple myeloma.

FDA Clears Quidel’s Lyme Disease Test

Quidel has received 510(k) clearance and a CLIA waiver from the Food and Drug Administration for its Sofia 2 Lyme Fluorescent Immunoassay (FIA) to aid in the diagnosis of Lyme disease. This test uses a bi-directional test strip for the rapid differential detection of human immunoglobulin (Ig) M and IgG antibodies to Borrelia burgdorferi (B. burgdorferi) and is performed on fingerstick whole blood specimens from patients suspected of B. burgdorferi infection. Detection of IgM antibodies to B. burgdorferi is generally most significant in the earlier stages of Lyme disease, while IgG antibodies may remain detectable years after infection. The test runs on the Sofia 2 Fluorescent Immunoassay analyzer, which generates a result in as little as 3 minutes. This instrument uses the fluorescent chemistry design of Quidel’s original Sofia system while featuring an updated graphical user interface and optics system, integrated wireless connectivity, and a connection to Virena, Quidel’s data management system.

510(k) Clearance Granted to PerkinElmer for Newborn Screening Kit

PerkinElmer has earned clearance from the Food and Drug Administration (FDA) for the NeoBase 2 Non-Derivatized MSMS kit for newborn screening. Used with a tandem mass spectrometer, this kit quantitatively measures and evaluates up to 51 markers for a variety of metabolic disorders, including X-linked adrenoleukodystrophy and adenosine deaminase severe combined immunodeficiency. The analytes measured include traditionally screened amino acids and acylcarnitines, as well as succinylacetone, free carnitine, nucleoside, and lysophospholipid. Performed on a single dried blood spot sample, the NeoBase 2 involves a three-step workflow compared with derivatized assays that typically require 12 steps. It features a reformulated flow solvent that is designed to improve ionization and makes it easy to switch between the NeoBase 2 kit and PerkinElmer’s NeoLSD newborn screening kit for lysosomal storage disorders. The NeoBase 2 also works with PerkinElmer’s SpecimenGate Software, which includes database functionality and stores, manages, reviews, and reports results.

InBios Receives FDA Clearance for Dengue Test

The Food and Drug Adminis-tration (FDA) has cleared InBios’ DENV Detect NS1 ELISA kit for the early detection of Dengue virus NS1 antigen in human serum. This test is intended to help differentiate Dengue virus infection from infection with other flaviviruses that may cross react with dengue antibodies but not with the antigen. The kit demonstrates a sensitivity of 86.6% and a specificity of 97.8%, and it includes one 96-well strippable plate with all necessary reagents and controls. It should be used to evaluate samples collected from patients within 7 days after the onset of clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever, according to InBios. Negative results do not preclude the diagnosis of dengue, however, and should not be used as the sole basis for treatment or other patient management decisions. This assay also is not FDA-cleared or approved for testing blood or plasma donors.

CE Mark Given to Asuragen’s NGS Oncology Panel

Asuragen has earned the CE mark for the Quantidex NGS DNA Hotspot 21 kit, a targeted next-generation sequencing panel for the detection of 1,600 clinically relevant variants across a multitude of tumor types, including non-small cell lung cancer, colorectal cancer, and melanoma. The genomic variants detected include single nucleotide variants, insertions/deletions, and structural rearrangements, many of which are treatable with novel therapies and inform patient management. The kit features Asuragen’s trademarked NGS-in-a-Box workflow, which complies with Food and Drug Administration Current Good Manufacturing Practice regulations and provides the necessary reagents to prepare sequencing-ready libraries in as little as a day. NGS-in-a-Box also incorporates analytics to standardize results after sequencing. In addition, the kit uses Asuragen’s proprietary Sample-Aware bioinformatics software, which assesses whether sufficient amplifiable DNA is present in each sample. The Quantidex NGS DNA Hotspot 21 kit runs on the Illumina MiSeq platform. In the U.S. it is currently indicated for research 
use only.