PrognomiQ just shared initial results from its ongoing real-world study for ProVue Lung, a blood test designed to detect lung cancer early in high-risk individuals.
Released on May 12, the results showed that in the first 78 participants the test caught all eight confirmed lung cancers, including five at stage I. The company reported 89 per cent overall sensitivity, 83 per cent sensitivity for stage I cancers and 54 per cent specificity.
These numbers appear promising because doctors rarely catch lung cancer at stage I today, and early detection sharply improves survival. A reliable blood test could encourage more high-risk people to get screened beyond low-dose CT scans, which many avoid.
However, the study is small, with only eight cancers total in this early group. Results from such limited data frequently change in larger trials, so experts view the findings cautiously.
PrognomiQ offers ProVue Lung as a laboratory developed test or LDT. Labs create and perform LDTs under their own Clinical Laboratory Improvement Amendments-certified quality systems. This approach lets companies launch tests faster than those requiring full FDA clearance and quickly gather real-world evidence.
PrognomiQ built the test on a proteomics platform that analyzes large numbers of proteins in blood along with other signals. It introduced the test in late 2025 through an early access program with partner health systems. The test is novel because it focuses primarily on proteins instead of the circulating tumour DNA most other companies target.
Proteins often appear in higher amounts during early cancer and may provide different signals for lung tumours. Still, this difference does not yet prove it works better.
In a LinkedIn post from the medical director of a partner research organization, Allegheny Health Network, concerns were highlighted. One observer noted that 89 per cent sensitivity means the test would miss 11 out of 100 cancers in high-risk groups, which could give dangerous false reassurance. The 54 per cent specificity also suggests many healthy people would test positive and need extra scans or procedures.
Read more: Breath Diagnostics advances pre-op pneumonia screening with FDA breakthrough designation
ProVue Lung may one day rank alongside established tests
PrognomiQ’s diagnostics tool aims to compete with more advanced blood tests from companies like Guardant Health Inc (NASDAQ: GH) (FRA: 5GH), Personalis Inc (NASDAQ: PSNL) (FRA: 04X), Mercy BioAnalytics and Grail Inc (NASDAQ: GRAL) (FRA: NL0).
These companies offer more mature options, some already with Medicare coverage or multi-cancer claims.
Guardant and Grail typically show higher specificity but struggle with the earliest lung cancers. If PrognomiQ speeds up larger validation studies and boosts specificity, its proteomics approach could potentially prove superior for true early-stage detection.
At present, the small dataset and modest specificity make it too soon to claim it will outperform the leaders. Direct comparisons in bigger trials will have to decide its place.
Other innovative screening methods gain steam
Several non-blood screening modalities have also attracting attention in recent weeks.
Breath Diagnostics is advancing its OneBreath test that reads signals of lung cancer in exhaled breath with considerable accuracy. This medtech company just raised over US$2.5 million to propel advancement and commercialization of its technology.
Meanwhile, bioAffinity Technologies Inc (NASDAQ: BIAF) is currently offering CyPath Lung, a test that examines cells in patient sputum or phlegm to detect the disease. bioAffinity launched a major study on this test in March.
In addition, Japanese startup Craif and the University of Cambridge have developed screening tools that can detect the presence of lung cancer in a patient’s urine.
These options seek to simplify screening and reach people who avoid imaging. Doctors may eventually combine blood, breath, spit and urine tests to find more cancers early.
Read more: Prestigious medtech intelligence firm recognizes Breath Diagnostics for innovation
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