FDA greenlights first breathalyzer test for COVID-19

We’ve known for years that the coronavirus that causes COVID-19 can travel with each breath. Now, the FDA has granted its first green light to a test that can detect COVID-19. 

A portable breathalyzer developed by InspectIR Systems aims to deliver a result within three minutes by looking for the exhaled chemical compounds that can come with an infection. 

The device includes its own miniaturized mass spectrometer, shrunk down to about the size of a carry-on suitcase. It’s designed to be used under the supervision of a healthcare professional in locations such as doctors' offices, hospitals and mobile testing sites.

By blowing into a tube connected directly to the machine, InspectIR’s test searches for five specific volatile organic compounds that are produced by the body when it’s fighting off COVID. 

While positive results should be confirmed with a secondary PCR test, the FDA said the device’s negative results could be accurate enough for use in widespread screening settings when placed in context with the person’s recent exposures and their current signs and symptoms.

The emergency authorization was granted after the breathalyzer was examined in a large study of more than 2,400 people with or without symptoms. The study demonstrated a false-negative rate of less than 1%, according to the agency.

With only 4.2% of the study’s participants being confirmed as positive cases, the test’s negative predictive value reached 99.6%—meaning negative results are likely to be truly negative, even for those people in areas with a low prevalence or community spread of COVID-19. The FDA said the test delivered similar results in a follow-up study focused on the virus’s omicron variant.

InspectIR had previously been developing its system as a potential roadside device to screen for recent opioid or cannabis usage. The company said it expects to be able to produce about 100 COVID-19 breathalyzers per week, each capable of evaluating about 160 samples per day. 

The nascent field of using exhaled breaths for diagnosis has seen other companies pursue tests for COVID-19, including Breathonix, a startup launched from the National University of Singapore, which received a provisional marketing authorization in the country.

Other companies, such as former Fierce 15 winner Owlstone Medical, have been developing breath-based biopsy tests for cancer and diseases affecting the lungs, liver and digestive system. Owlstone raised $58 million last year after launching its first commercial screening panel for telling the difference between different chronic inflammatory airway conditions including asthma, idiopathic pulmonary fibrosis and chronic obstructive pulmonary disease.