COMPASS Research Report | Page 19

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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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