FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests

There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective investigational medical products “to address this urgent public health situation.”

As with previous infectious disease outbreaks like Zika, the FDA will clear new 2019-nCoV tests and treatment products on an expedited basis via the Emergency Use Authorization (EUA) pathway. The FDA is calling on diagnostic test sponsors interested in potential EUA for detection tests to contact the Center for Devices and Radiological Health (CDRH) ( for information and templates.

The FDA has also created a landing page to keep product developers and the public informed about the outbreak and the FDA’s response measures.

New FDA Approvals

Key new product approvals announced from late December 2019 through late-January 2020:


Manufacturer(s) Product(s)
DNA Genotek (subsidiary of OraSure Technologies) 510(k) clearance for Oragene Dx sample collection kits
Geneoscopy Breakthrough device designation for colorectal cancer screening test based on extraction of stool-derived eukaryotic RNA transcripts
KDx Diagnostics Breakthrough device designation for URO17 Bladder Cancer Recurrence Test
Luminex Clearance for NxTag Respiratory Pathogen Panel qualitative test run on firm’s Magpix instrument to simultaneously detect and identify nucleic acids from multiple respiratory viruses and bacteria
Microgenics Clearance for Cedia Benzodiazepine Assay, a homogeneous enzyme immunoassay to detect benzodiazepines in human urine at cutoff concentration of 200 ng/mL
Sentinel Diagnostics Clearance for Albumin BCP assay measuring albumin in human serum or plasma
i-Sens Clearance for ReliOn Premier Classic Blood Glucose Monitoring System measuring glucose in fresh capillary whole-blood samples drawn from fingertips, forearm, palm, thigh or calf
Promisemed Hangzhou Meditech Clearance for Promisemed Heel Blood Lancet for collection of capillary blood from heels of newborn or premature babies
Immunotech Vit Oburka Clearance for Active Free Testosterone RIA test radioimmunoassay used to measure free testosterone in human serum
Applied BioCode 510(k) clearance for BioCode Respiratory Pathogen Panel (RPP) for use on BioCode MDx-3000 system
Qiagen Clearance for Therascreen PIK3CA RGQ PCR Kit as companion diagnostic to identify advanced breast cancer patients with PIK3CA mutations likely to respond to Novartis’ Piqray (alpelisib)
Applied BioCode 510(k) clearance for BioCode respiratory pathogen panel diagnostic test used with firm’s MDx-3000 system for detecting common respiratory viruses and bacteria
AstraZeneca + Merck Expanded indication for olaparib (Lynparza) as a maintenance treatment for metastatic pancreatic cancer patients identified via a companion diagnostic
Curetis Clearance for Unyvero LRT lower respiratory tract application cartridge


New CE Marks & Global Certifications

Notable European CE certifications announced during the period:


Manufacturer(s) Product(s)
Roche CE marking for adenovirus infections test for immunocompromised transplant recipients to run on Roche Cobas 6800/8800 systems
Proteomics International Laboratories CE marking for PromarkerD Hub software for calculating risk of kidney disease in type 2 diabetes patients
Genome Diagnostics CE marking for its NGSgo-MX6-1 and NGSgo-AmpX v2 HLA typing products
ProciseDx CE marking for Procise C reactive protein (CRP) assay for use with ProciseDx rapid diagnostic testing platform
MGI Tech CE-IVD marking for DNBSEQ-T7, DNBSEQ-G400 + DNBSEQ-G50 instruments
CareDx CE marking for AlloSeq cfDNA kit


Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Sysmex China National Medical Products Administration Class III approval for Lynoamp BC diagnostic reagent
Co-Diagnostics India Central Drug Standard Control Organization IVD approval for CoSara tests for tuberculosis, malaria, hepatitis B, hepatitis C + human papillomavirus
Chugai Pharmaceutical (Roche subsidiary) Japan Ministry of Health, Labor and Welfare approval for Foundation Medicine’s FoundationOne CDx Cancer Genomic Profile as companion diagnostic for entrectinib (Roche’s Rozlytrek)

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