FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test

Texas firm InspectIR has won the race to bring the first SARS-CoV-2 breathalyzer test to the US market. On April 14, the FDA announced that it has granted Emergency Use Authorization (EUA) for the InspectIR COVID-19 device that detects the virus from breath samples in less than three minutes.

The Next Big Thing in Rapid COVID-19 Testing

While slow but accurate polymerase chain reaction (PCR) tests will remain the gold standard for diagnosis, rapid, low-cost, and scalable point-of-care tests used for screening asymptomatic populations represent the most likely growth area in the COVID-19 diagnostics market. Currently, that space is occupied by two kinds of tests: Serology tests that detect SARS-CoV-2 antibodies and antigen tests that detect antigens secreted by those antibodies. Breathalyzer tests use a different biomarker to detect the virus: volatile organic compounds (VOCs) expelled by the lungs. In addition to offering greater accuracy and speed, breathalyzer tests are less invasive than current SARS-CoV-2 rapid tests that rely on lung tissue samples collected by swabs.

The InspectIR COVID-19 Breathalyzer

InspectIR won the race to the US market by leveraging its portable opioid and cannabis gas chromatography-mass spectrometry (GC-MS) technology to develop a device capable of separating and identifying five VOCs associated with SARS-CoV-2 in exhaled breath. Patients breathe into a disposable straw on the device, which is roughly the same size as a piece of carry-on luggage, with results provided in less than three minutes. InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day. At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month. However, COVID-19 breathalyzer tests come with a caveat: the results they produce can’t be accepted as conclusive. According to the FDA, a test that does detect SARS-CoV-2 VOCs should be considered a presumptive (unconfirmed) positive test result and be confirmed with a molecular test. In addition, the agency cautions that negative results don’t totally rule out SARS-CoV-2 infection and shouldn’t be used as the sole basis for treatment or patient management decisions. The agency calls on practitioners to consider a negative result in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.

SARS-CoV-2 Breathalyzers in the Pipeline The InspectIR device is only the start of what promises to be a flow of SARS-CoV-2 breathalyzer products in the US and around the world. Other projects in the works include: • The National Aeronautics and Space Administration (NASA) is testing a prototype of a COVID-19 breathalyzer device called E-Nose originally developed by Tennessee subcontractor Variable Inc. to measure air quality inside a spacecraft (See, Diagnostic Testing and Emerging Technology, May 22, 2021); • Canary Health Technologies and Divoc Laboratories are collaborating to develop and validate a handheld digital breath test called ASU Detect CV19, which uses cloud-based AI technology to detect the SARS-CoV-2 virus in less than three minutes (See, Laboratory Industry Report, February 22, 2021); • Singapore startup Silver Factory Technology has begun testing a SARS-CoV-2 breathalyzer at Singapore Changi Airport and plans to build a facility to mass produce the device; and • Breathonix, another Singapore firm, which was spun off from the National University of Singapore, began testing its own SARS-CoV-2 breath test at a busy bridge checkpoint in Malaysia that’s used to test hundreds of incoming truck drivers a day.

Here are the other important new FDA Emergency Use Authorizations (EUAs) and clearances announced in April 2022:

New FDA Emergency Use Authorizations (EUAs) & Approvals

Manufacturer(s)	Product
Opti Medical Systems	EUA for Opti SARS-CoV-2/Influenza A/B RT-PCR Test
Quanterix	Breakthrough device designation for blood test to detect relapsing-remitting multiple sclerosis
MicroGem	EUA for MicroGem Sal6830 SARS-CoV-2 Saliva Test
Cleveland Clinic	EUA for SelfCheck Cobas SARS-CoV-2 + Flu Assay PCR test based on Roche's Cobas SARS-CoV-2 & Influenza A/B test
Q-linea	Breakthrough Device designation for ASTar antimicrobial susceptibility test
University of California, San Diego	EUA for UCSD EXCITE COVID-19 EL Test, PCR assay
D.C. Health	EUA for direct-to-consumer Test Yourself DC At-Home COVID-19 Collection Kit
Osang Healthcare	EUA for OHC COVID-19 Antigen Self Test lateral flow immunoassay
Xiamen Boson Biotech	EUA for Rapid SARS-CoV-2 Antigen Test Card lateral flow immunoassay
DNA Genotek (subsidiary of OraSure Technologies)	De novo authorization for Omnigene-Gut Dx device for self-collection and stabilization of microbial DNA from human feces for gut microbiome profiling
Siemens Healthineers	Breakthrough device designation for Advia Centaur serum Neurofilament Light Chain test

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New CE Markings in Europe

Manufacturer(s)	Product(s)
Pathonostics	DermaGenius 3.0 Complete Multiplex real-time PCR kit
Qvella	FAST System and FAST-PBC Prep Cartridge to process positive blood cultures for sepsis testing
Genetron Health	Human B lymphocyte minimal residual disease detection test kit, Seq-MRD
Eurobio Scientific	Eurobioplex SARS-CoV-2 Fast-SVT for simultaneous detection of Omicron BA1, Omicron BA2, and Delta variants
C2i Genomics	C2inform test quantifying the minimal residual disease (MRD) left behind in cancer patients after surgery
SeekIn	LeukoPrint Molecular Karyotyping Kit for the diagnosis and stratification of leukemia patients
Paige	Paige Breast Lymph Node artificial intelligence software
Seegene	Allplex RV Master Assay for respiratory viruses
Agilent Technologies	Expanded CE-IVD marking for use of PD-L1 IHC 28-8 pharmDx immunohistochemical assay as companion diagnostic test to guide treatment for newly approved indications for Bristol Myers Squibb's Opdivo
Thermo Fisher Scientific	Ion Torrent Genexus Dx Integrated Sequencer
Innova Medical Group	Innova SARS-CoV-2 Antigen Rapid Qualitative Test
Baebies	Finder SARS-CoV-2 point-of-care test

Other international clearances announced during the period:

Manufacturer(s)	Country(ies)	Product(s)
CoSara Diagnostics	India	Saraq Hepatitis C Viral Load kit
Fosun Pharmaceutical	China	Fosun Diagnostic's Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold) for COVID-19 screening
Qiagen	South Korea	Therascreen KRAS RGQ PCR Kit as CDx to identify patients with KRAS G12C-mutated non-small cell lung cancer eligible for Amgen's KRAS inhibitor Lumakras (sotorasib)
Seegene	Australia	Allplex RV Master Assay for respiratory viruses
Genome Diagnostics	Canada	NGSgo-MX11-3 human leukocyte antigen genotyping test
BioLytical Laboratories	Canada	iStatis COVID-19 Antigen Home Test