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Organic compounds in a patient ’ s breath offer a novel non-invasive method to diagnose lung cancer
Close to a better screening method than CT scans for lung cancer Lung cancer is the largest cause of cancer-related deaths and represents a significant burden on healthcare systems . Current tests in development complement CT scans include the CyPath Lung which analyses cells in sputum samples and uses porphyrin to identify suspicious cells . Biodesix use immune cells to measure auto-antibodies that risk-assess lung nodules identified by CT scanning with $ 29.3m in revenue for the test in 2022 . The future of lung cancer diagnostics is likely to be liquid biopsy based . Delfi diagnostic ’ s methylated CtDNA test that detected 80 % of stage 1 cancers and would have reduced unnecessary biopsies by half compared to low dose Ct scanning . Other lung cancer screenings identify volatile organic compounds (“ VOC ”), whose presence is associated with lung cancer . Owlstone Medical has received funding from the NHS to continue this work and use their breath-based biopsy system Reciva to analyse VOC and diagnose lung cancer . Lung cancer is closer to having one of these tests replace conventional screening methods and larger companies acquiring the technology for these tests are likely .
Table 7 : Lung cancer non-invasive tests |
Company |
Product |
Sample |
Method |
Bioaffinity Technologies Inc . |
CyPath Lung |
Sputum |
Biomarker |
Biodesix Inc |
Nodify XL2 |
Blood |
Proteomics |
Delfi Diagnostics |
Screening test |
Blood |
Liquid biopsy – CtDNA |
Hawkeye Bio Inc . |
Respiragen |
Sample |
Enzyme-based biomarker |
Nucleix |
Lung Epicheck |
Blood |
Liquid biopsy – CtDNA |
Owlstone Medical |
ReCIVA |
Breath |
VOC |
Picomole Inc |
Test for lung cancer |
Breath |
VOC |
Stagezero Life Sciences Ltd . |
Early-CDT-lung |
Blood |
Enzyme-based biomarker |
Visiongate Inc . |
LuCED |
Sputum |
Cellular analysis |
Volitionrx Ltd . |
Nu . Q |
Blood |
Liquid Biopsy – EV |
Source : goetzpartners Research , BioCentury Inc .
Tests to replace or enhance the accuracy are close to becoming SoC
The PSA test has not been replaced yet While prostate cancer is the most prevalent male cancer , no test has yet replaced the PSA . There has been significant progress in the development of tests that can confirm a diagnosis as well as provide an indication of the aggressiveness of the disease . Several tests have been developed to help rule in or rule out the presence of cancer in men with elevated PSA ( Table 8 ). These tests focus on the detection of genetic markers such as methylated DNA or EVs released by cancer into the blood or urine . Further development has improved MRI accuracy and interpretation , decreasing the need for unnecessary blood tests and biopsies . In Norway and Sweden some providers have swapped the PSA for the Stockholm3 test , a combination of protein and genetic biomarkers and found reductions in direct health care costs and unnecessary biopsies , whilst improving the diagnosis of aggressive cancers . We expect confirmatory tests such as these to be the entry point for liquid biopsy tests before widespread adoption . Revenues are still small for many of these tests with MdxHealth revenue for the Confirm MDx test limited to $ 21.8m for 2022 .
Table 8 : Prostate cancer non-invasive tests |
Company |
Product |
Sample |
Method |
Anixa Biosciences |
Cchek Prostate |
Blood |
Liquid biopsy – immune cells |
Armune Biosciences |
Apifiny |
Blood |
Liquid biopsy – immune cells |
A3p Biomedical |
Stockholm3 |
Blood |
Protein biomarker and genetic drivers |
Bio-Techne Corp . |
ExoDx Prostate |
Urine |
Liquid biopsy – EV |
Nucleobio Inc . |
Prostac |
Urine |
Liquid biopsy – CtDNA |
Opko Health Inc . |
4Kscore Test |
Blood |
Protein-based biomarker |
Proteomedix |
Proclarix |
Blood |
Protein-based biomarker |
Hologic |
Progensa |
Urine |
mRNA |
Mdxhealth |
Confirm MDx |
Urine |
Liquid biopsy – CtDNA |
Source : goetzpartners Research , BioCentury Inc .
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