INDUSTRY BUZZ

FDA Watch: Agency Okays EIA Technology-Based Lyme Assays

Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against Borrelia burgdorferi, the bacteria that causes the disease, in a patient’s blood. Traditional testing uses a two-tier approach in which a pair of enzyme immunoassays (EIA) are performed followed by a separate protein test called a Western blot to confirm a Lyme disease diagnosis. But on July 29, 2019, the FDA broke new ground by clearing for the first time ever tests that follow a different model relying only on EIA technology-based tests which can be run concurrently or sequentially. The products which were approved via the FDA 510(k) pathway were all developed by Branchburg, NJ-based Zeus Scientific, including:

  • The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System;
  • The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System;
  • The ZEUS ELISA Borrelia burgdorferi IgM Test System; and
  • The ZEUS ELISA Borrelia burgdorferi IgG Test System

In granting 510(k) clearance, the FDA relied on data from clinical studies demonstrating that the alternative modified two-tier test approach is just as accurate as current methods for detecting antibodies for assessing exposure to Borrelia burgdorferi. The FDA also reiterated in announcing the clearance that CDC recommendations should be followed for the diagnosis of Lyme disease and for determining when laboratory tests are appropriate.

New FDA Approvals

Here’s a look at other new product approvals announced from late July through late August:

NEW FDA APPROVALS
Manufacturer(s) Product(s)
Zeus Scientific Clearance for four EIA-based Lyme disease tests (see above for list)
Siemens Healthineers Clearance for Atellica CH Amylase 2 assay running on firm’s Atellica CH Analyzer to measure amylase activity in serum, plasma and urine and diagnose acute pancreatitis
Siemens Healthineers Clearance for Advia Centaur Zika test to detect immunoglobulin M antibodies to Zika virus in serum and plasma specimens using the Siemens Advia Centaur XP + Advia Centaur XPT systems
Agilent Technologies Expanded clearance for use of its Dako PD-L1 IHC 22C3 pharmDx assay as companion diagnostic test for Merck’s anti-PDL-1 immunotherapy pembrolizumab (Keytruda) for esophageal squamous cell carcinoma (ESCC)
Becton Dickinson Clearance for BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
Hycor Biomedical Clearance for Noveos Specific IgE Assay, Capture Reagent House Dust Mite D002, Dermatophagoides Farina
Abbott 510(k) clearance for software modification to the ID Now Influenza A & B 2 test (previously called the Alere i), rapid multiplex nucleic acid assay for detection and differentiation of influenza A and influenza B in patients with respiratory infection symptoms
Roche Diagnostics 510(k) clearance for software modification to its Cobas Influenza A/B test running on Cobas Liat point-of-care system
Healthy.io Clearance for its ACR LAB Urine Analysis Test System consisting of a smartphone app, color board + ACR reagent strips
iCubate Breakthrough Device designation for its iC-Myco Assay for detection and identification of potentially pathogenic non-tuberculosis Mycobacterium (NTM)

New CE Marks & Global Certifications

Notable European CE certifications during the period:

NEW CE MARKINGS IN EUROPE
Manufacturer(s) Product(s)
Accelerate Diagnostics CE IVD marking for expanded version of its PhenoTest BC kit including additional antimicrobial susceptibility testing
Ortho Clinical Diagnostics CE marking for enhanced version of its Vitros NT-proBNP II assay to diagnose heart failure and enable risk stratification of heart failure and acute coronary syndrome
NeuMoDx CE-IVD markings for molecular assays to detect cytomegalovirus (CMV) and Epstein-Barr virus

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Sysmex Japan Ministry of Health, Labor, and Welfare approval for its OncoBEAM RAS Colorectal Kit for mutations in the RAS gene in blood-based circulating tumor DNA (ctDNA) for late-stage CRC patients
Ortho Clinical Diagnostics Canada Health Canada approval for its next-generation Vitros High Sensitivity Troponin I assay to identify heart attack
Roche China National Medical Products Administration extended approval for Roche Cobas EGFR Mutation Test v2 to include use of plasma samples to detect EGFR mutations in non-small cell lung cancer patients
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