A disease diagnosis may be as simple as breathing! A breath biopsy is a diagnostic method that analyzes the volatile organic compounds (VOCs) in a person’s breath to detect diseases. Think of it as a “disease breathalyzer.”

The Basic Science:

The complete set of biochemical reactions our cells use to create energy is called cellular metabolism.

Byproducts of cellular metabolism are organic compounds that contain carbon. They empty into our bloodstream and are expelled from our lungs when we exhale. Scientists refer to the stuff we breathe out as volatile organic compounds (VOCs) or metabolites.

VOCs can indicate metabolic changes in the body, which appear before other disease symptoms. Detecting these changes can lead to early diagnosis and more effective treatment.

Why It Matters:

The earlier a doctor can detect an illness, the more likely a good outcome, saving patient’s time, money, and grief.

Breath biopsies are non-invasive, painless, highly sensitive, and capable of detecting minute concentrations of suspicious VOCs. Breath biopsies can detect disease before symptoms occur.

The Applied Science:

Cancer cells consume glucose two hundred times faster than healthy cells. Malignant cells also use anaerobic (without oxygen) metabolic pathways rather than aerobic (with oxygen) pathways preferred by healthy cells. The glucose use and alternative metabolic pathways create different byproducts detected as VOCs.

Other diseases that produce altered VOCs include diabetes, liver impairment, kidney disease, asthma, cystic fibrosis, rheumatoid arthritis, atherosclerosis, and tuberculosis.

Around the Bend:

Owlstone Medical (Cambridge, U.K.) is developing a diagnostic based on VOCs with their ReCIVA Breath Sampler.

Breath biopsies aren’t yet available as an FDA-approved diagnostic tool. Owlstone Medical is currently running the following trials to demonstrate what a breath biopsy can do in action:

• LuCID (Lung Cancer Indicator Detection): This study analyzes and validates unique VOCs in lung cancer patients’ exhalations.
• STRATA (Stratification of Asthma Treatment by Breath Analysis): This study examines how VOCs may help select the best asthma treatment.
• INTERCEPT: This study identifies and validates VOCs to detect colorectal cancer.
• PAN (PAN-Cancer Early Detection): This study determines VOCs associated with many cancers, including bladder, breast, head and neck, kidney, esophageal, pancreas, and prostate.

Diagnostic Approval:

Bringing a breath biopsy diagnostic to the marketplace is not simple. However, learning the development and approval pathway is easy when you have Biotech Primer’s Diagnostic Development Primer 40-minute class helping you navigate the complex world of FDA regulations for molecular diagnostics.

Cocktail Fodder:

Canine noses contain 220 million scent receptors, which scientists have found are sensitive to VOCs in our breath, sweat, saliva, and urine. Dogs can detect seizures in humans through their highly sensitive sense of smell. It is hypothesized that dogs pick up on volatile organic compounds that are released by the body before a seizure occurs. Dogs detect these scent changes and alert their person to an oncoming seizure. This ability has led to training specialized seizure-alert dogs that can provide warning signals before a seizure happens. Seizures aren’t the only disease canines can detect via VOC’s; dogs can also detect cancer!