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

New FDA Emergency Use Authorizations (EUAs) & Approvals

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

New CE Markings in Europe

Other international clearances announced during the period: