INDUSTRY BUZZ

FDA Watch: First NGS Residual Cancer Detection Test Wins Approval

The FDA broke new ground by allowing marketing of Adaptive Biotechnologies’ ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma.

PCR v. NGS
MRD is a general measure of the amount of cancer in the body (tumor burden), specifically the number of cancer cells that remain in a person’s bone marrow, either during or after treatment. Measuring MRD provides a tool to detect very low levels of tumor burden. MRD is useful to evaluate in patients who have responded to therapy when their tumor burden is below what can be detected with standard methods. The detection of MRD is associated with recurrence of the disease in those patients. Currently, providers test for MRD using diagnostics called flow cytometry assays or polymerase chain reaction (PCR)-based assays. Those methods are usually capable of measuring MRD down to 1 in 10,000 or 1 in 100,000 cells.

By contrast, ClonoSEQ is an in vitro diagnostic that uses multiplex PCR and NGS to identify and quantify certain gene sequences in DNA extracted from bone marrow from patients with ALL or multiple myeloma. The ClonoSEQ assay measures the amount of MRD and is capable of detecting MRD at levels below 1 in 1 million cells.

New FDA Approvals
Here’s a look at some of the key FDA approvals announced at the end of October through the third week of November:

NEW FDA APPROVALS
Manufacturer(s) Product(s)
Becton Dickinson Clearance for BD Phoenix CPO test
BioFire Diagnostics 510(k) clearance for PCR-based panel to detect 33 common pathogens causing lower respiratory tract infections
Siemens Healthineers Breakthrough Device designation for Advia Centaur Enhanced Liver Fibrosis (ELF) test
PixCell Medical Approval for marketing HemoScreen Hematology Analyzer
Ortho Clinical Diagnostics Approval of Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Vitros 5600 Integrated System
Ortho Clinical Diagnostics Clearance for Vitros XT 7600 Integrated System
23andMe Authorization to sell tests for 33 pharmacogenetic variants directly to consumers
EliTech Group   510(k) clearance for ELITe MGB HSV 1&2 Assay and Elite InGenius instrument
Aptatek BioSciences Breakthrough Device designation for phenylketonuria (PKU) test system
Bio-Rad Laboratories 510(k) clearance for (BIO +1.1%) IH-Reader 24, semi-automated blood typing system
Abbott Clearance for NGS Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing
Ansh Labs Clearance for PicoAMH ELISA diagnostic test as an aid in determining a patient’s menopausal status
Inova Diagnostics Clearance for fecal extraction device for use with the firm’s Quanta Flash Calprotectin assay
LabCorp Clearance for Extended Lipid Panel Assay for quantitative determination in human serum and plasma of total cholesterol, HDL cholesterol and triglycerides running on LipoScience Vantera Clinical Analyzer
Sysmex Clearance for UD-10 Fully Automated Urine Particle Digital Imaging Device
Diazyme Laboratories Clearance for enzymatic assay for detection of 1,5- anhydroglucitol for intermediate monitoring of glycemic control of patients with diabetes
Phamatech Clearance for QuickScreen Pro Multi Drug Screening test for drugs of abuse
Binding Site Group Clearance for Optilite High Sensitivity C-Reactive Protein kit
Immunalysis E Clearance for Ethyl Alcohol Enzyme Assay for analysis of ethyl alcohol or ethanol with automated clinical chemistry analyzers
Immuno Concepts Clearance for Histofluor Rodent LKS Fluorescent Antibody Test System for detection of IgG autoantibodies

New CE Marks & Global Certifications
Notable European CE certifications:

NEW CE CERTIFICATIONS IN EUROPE
Manufacturer(s) Product(s)
Mesa Biotech CE marking for Mesa RSV molecular diagnostic assay to detect respiratory syncytial virus
Quotient   CE marking for MosaiQ instrument
RPS Diagnostics CE marking for updated FebriDx test for identifying clinically significant underlying febrile acute respiratory infections
PlexBio CE marking for IntelliPlex Lung Cancer Panel molecular diagnostic assay for qualitative identification of 36 DNA mutations
MRC Holland CE-IVD marking for SALSA MC002 assay for spinal muscular atrophy (SMA) screening in newborns

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Asuragen
+
MolecularMD
Canada Health Canada approval for BCR-ABL tests for use in chronic myeloid leukemia (CML) patients
MolecularMD Canada   Health Canada approval for PCR-based MRDx BCR-ABL test as aid to monitor TKI treatment in Philadelphia chromosome positive CML patients
Illumina Japan Pharmaceuticals and Medical Devices Agency approval for NextSeq 550Dx sequencing platform
Agena Biosciences
+
DaRui Biotechnology
China China Food and Drug Administration approval for Agena’s MassArray system
Zeesan Biotech China China Food and Drug Administration approval for MeltPro High Risk HPV test
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