FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
From - Laboratory Industry Report The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for… . . . read more
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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