FDA Watch: First Zika Assay Gets Green Light for Marketing
From - Laboratory Industry Report Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for… . . . read more
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It authorized marketing of a diagnostic test for the Zika virus—specifically, Seattle-based InBios’ ZIKV Detect 2.0 IgM Capture Elisa for detecting immunoglobulin (IgM) antibodies in human blood, an assay previously cleared for emergency use only.
The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body’s immune system when it tests for Zika virus infection in the blood. IgM antibodies indicate an early immune response. The test is for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or who meet the CDC’s Zika virus epidemiological criteria, such as a history of residence in or travel to a geographic region with active Zika transmission at the time of travel. The FDA authorization doesn’t cover testing of blood or plasma donors.
Moving beyond EUA to marketing authorization is a seminal shift in FDA policy. Comfort with the effectiveness of the InBios Zika assay enabled the agency to take the next step. According to InBios, the assay was evaluated via testing 807 unique specimens—353 from test subjects at sites where Zika is endemic and 256 subjects at non-endemic sites. In samples from patients collected seven days or later after the onset of symptoms, the InBios Zika kit correctly identified over 90% of patients confirmed positive for Zika IgM and over 96% of patients confirmed negative.
The authorization doesn’t impact the availability of the 14 other Zika nucleic acid diagnostics available under EUAs.
Other New FDA Approvals
Late May through the third week in June, 2019 was the busiest month of the year for FDA approvals. Here’s a look at other approvals announced during the period.
| NEW FDA APPROVALS | ||
| Manufacturer(s) | Product(s) | |
| Bio-Techne | Breakthrough device designation for ExoDx Prostate IntelliScore liquid biopsy test | |
| SpeeDx | Breakthrough device designation for ResistancePlus GC molecular test | |
| Applied BioCode | 510(k) clearance for use of Roche MagNa Pure 96 Extraction System with high-throughput BioCode MDx-3000 and BioCode Gastrointestinal Pathogen Panel | |
| Siemens Healthineers | Clearance for Dimension Exl High-Sensitivity Troponin I Assay to diagnose acute myocardial infarction running on its Dimension Exl integrated chemistry system | |
| Roche | Clearance for Cobas u 601 urinalysis test system to measure urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes | |
| PerkinElmer | Clearance for NeoLSD Msms Kit to measure the activity of enzymes in dried blood spots | |
| Maine Molecular Quality Controls | Clearance for its FilmArray Pneumonia/Pneumonia plus Control | |
| BioMérieux | Clearance for Bact/Alert MP Reagent System for use with firm’s Bact/Alert 3D Mycobacteria Detection Systems | |
| Haemonetics | Clearance for Teg 6s Hemostasis System to provide an indication of hemostasis state of a venous blood sample | |
| Agilent Technologies | Expanded approval for Dako PD-L1 IHC 22C3 pharmDx assay as companion diagnostic test for Merck’s anti-PDL-1 immunotherapy pembrolizumab (Keytruda) for head and neck squamous cell carcinoma (HNSCC) | |
| Itamar Medical | Clearance for fully disposable sleep apnea test | |
| BrainBox Solutions | Breakthrough device designation to BrainBox TBI test for diagnosis and prognosis of mild traumatic brain injuries | |
| Akonni Biosystems | 510(k) clearance for TruDiagnosis molecular diagnostics system and pharmacogenomics assay to identify genetic signatures associated with metabolism of the blood thinner warfarin (Coumadin) | |
| Resolution Bioscience | Breakthrough device designation for liquid biopsy assay, Resolution HRD to detect sequence variations in genes related to homologous recombination deficiency | |
| DiaSorin Molecular | Clearance for Simplexa VZV Direct assay for detecting varicella-zoster virus | |
| CD Diagnostics | Clearance for Synovasure test kit to determine if swelling around a prosthetic joint replacement is being caused by an infection | |
| Hologic | Clearance for Aptima BV test for bacterial vaginosis run on Panther and Panther Fusion systems | |
| Hologic | Clearance for Aptima CV/TV test to detect and differentiate common causes of yeast infections from parasitic trichomonas infections run on Panther and Panther Fusion systems | |
| Leica Biosystems (Danaher) | Clearance for Aperio AT2 DX System | |
| Inova Diagnostics | Clearance for Quanta Flash RF IgA immunoassay for quantitative determination of IgA RF antibodies in serum | |
| Inova Diagnostics | Clearance for Quanta Flash Rheumatoid Factor IgM immune assay for quantitative determination of IgM RF antibodies in serum | |
| InBios | Clearance for ZIKV Detect 2.0 IgM Capture ELISA assay to detect Zika virus immunoglobulin antibodies in blood samples previously cleared for emergency use only | |
| Amprion | Breakthrough device designation for test to detect prion biomarkers for diagnosis of Parkinson’s disease | |
| Qiagen | Clearance for Therascreen PIK3CA RGQ PCR Kit as companion diagnostic to identifying which advanced breast cancer patients have PIK3CA mutations and are thus likely to respond to Novartis’ alpelisib (Piqray) | |
| CD Diagnostics | de novo premarket approval for Synovasure Lateral Flow Test Kit used to detect periprosthetic joint infection after a joint replacement | |
| True Diagnostics | 510(k) clearance for VeriClear Digital Early Result pregnancy test | |
New CE Marks & Global Certifications
Notable European CE certifications during the period:
| NEW CE MARKINGS IN EUROPE | ||
| Manufacturer(s) | Product(s) | |
| Becton Dickinson | CE marking for BD Cor System, high-throughput modular, and scalable, molecular diagnostics solution | |
| Almac Diagnostic Services | CE marking for NGS-based diagnostic assay to be used to determine molecular eligibility for enrolling patients in Phase 2 portion of a cancer drug clinical trial | |
Other international clearances announced during the period:
| Manufacturer(s) | Country(ies) | Product(s) |
| Invivoscribe | Japan | Ministry of Health, Labor, and Welfare (MHLW) approval for LeukoStrat CDx FLT3 Mutation Assay as companion diagnostic for Daiichi Sankyo’s quizartinib for treating FLT3-ITD positive relapsed or refractory acute myeloid leukemia (AML) patients |
| Myriad Genetics | Japan | Pharmaceuticals and Medical Devices Agency approval for olaparib (Lynparza) as first-line maintenance treatment after BRCA-mutated advanced ovarian cancer patients responde to platinum-based chemotherapy |
| Myriad Genetics | Japan | Pharmaceuticals and Medical Devices Agency approval for manufacturing and marking of its BRACAnalysis Diagnostic System |
| Macrogen | South Korea | Ministry of Food and Drug Safety Good Clinical Laboratory Practice accreditation awarded to labs that analyze blood and urine samples for clinical trials |
| Todos Medical | Israel | Ministry of Health approval for marketing its TM-B1 and TM-B2 breast cancer screening tests |
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