Written and Reviewed by Team Pharmacally
Many cancers found in the early stages (Stage I or II) show much better survival rates than those diagnosed at later stages (Stage III or IV). Detecting cancer early greatly improves the chances of successful treatment and increases patient survival rates. In an exciting advancement, Novelna Inc., a biotechnology company based in the U.S., has launched a blood test based on proteomics that can accurately identify 18 different types of early-stage cancers.
About Novelna Inc
Novelna Inc., a startup focused on proteomics and liquid biopsies, has achieved a major milestone in the early detection of cancer. A study released in BMJ Oncology in January 2024 revealed that Novelna has developed an innovative screening test that employs a sex-specific panel of 10 proteins to accurately identify 18 different types of early-stage cancers.
Key Features of Novelna’s Cancer Screening Test
Sex-Specific Accuracy: By concentrating on sex-specific proteins, the test attains impressive sensitivity and specificity, taking into account the distinct biological differences in how cancer presents in men and women.
High Sensitivity for Early Stages: The test also showed more than 80% sensitivity for Stage I and II cancers, which is a significant improvement over current methods that usually have less than 50% sensitivity for early-stage cancers.
Tissue of Origin Identification: Additionally, it successfully identified the tissue of origin for the majority of cancers in over 80% of cases.
This development highlights the promise of proteomics in transforming cancer diagnostics, providing a more precise and less invasive method for early detection. By recognizing molecular changes prior to the onset of physical symptoms, Novelna’s test opens the door to better patient outcomes and tailored healthcare.
The Science behind the Test
Traditional cancer screenings typically emphasize genetic markers or imaging techniques. Novelna’s proteomics-based cancer detection test marks a significant leap forward in early cancer diagnostics by examining protein biomarkers found in blood plasma. Proteomics, which involves the extensive study of proteins, provides real-time insights into how the body responds to diseases like cancer, allowing for the identification of molecular changes before any physical symptoms appear. In a study published in BMJ Oncology, researchers gathered plasma samples from 440 individuals, including both healthy participants and those diagnosed with early-stage solid tumors across 18 different cancer types. Using the Olink Explore 3072 high-throughput protein biomarker discovery platform, they analyzed over 3,000 proteins to pinpoint specific protein signatures linked to each cancer type. The findings indicated that a sex-specific panel of 10 proteins could accurately detect early-stage cancers—achieving up to 93% accuracy in males and 84% in females. Interestingly, the most effective biomarkers were proteins found in low concentrations.
The plasma proteome shows that the protein signatures differ between sexes. This proteomics-based method has several benefits compared to traditional genomics-based liquid biopsies, which tend to have lower sensitivity for detecting early-stage cancers and are generally more costly. By concentrating on protein expression, Novelna’s test offers a more precise representation of the current disease state, which could result in earlier detection and better patient outcomes.
Implications of Novelna’s Proteomics-Based Test for Cancer Screening
Enhanced Early Detection
Proteomics-based tests, such as those developed by Novelna, examine protein biomarkers found in bodily fluids. This approach may allow for the detection of cancers at earlier stages compared to traditional methods like imaging and biopsies. Early detection is vital for enhancing survival rates, as treatments tend to be more effective when cancers are still localized.
Multi-Cancer Screening Potential
Proteomics has the potential to detect several types of cancer at once, unlike single-cancer tests such as mammography for breast cancer. This approach is in line with the new multi-cancer early detection (MCED) technologies, as it focuses on protein dynamics. These dynamics may provide a more accurate reflection of real-time physiological changes compared to genomic or transcriptomic signals.
Improved Sensitivity and Specificity
If validated, high sensitivity could help reduce false negatives, while high specificity might limit unnecessary follow-ups. However, it’s crucial to rigorously test performance across diverse populations to prevent disparities in efficacy.
Non-Invasive and Patient-Friendly
Blood-based proteomic tests offer a less invasive alternative to biopsies or colonoscopies, which could lead to higher screening adherence and allow for a wider reach within the population.
Cost and Accessibility Challenges
While the potential is significant, the high costs of development and the need for specialized equipment could restrict initial access. For widespread adoption to occur, it will be essential to ensure affordability and seamless integration into current healthcare systems, especially in resource-limited environments.
Regulatory and Clinical Validation Hurdles
Regulatory approval, such as from the FDA or EMA, necessitates comprehensive clinical trials that prove both safety and efficacy. Longitudinal studies are essential to verify if earlier detection leads to better survival outcomes.
Integration with Current Protocols
The test may serve to enhance current methods (for instance, as a triage tool) instead of completely replacing them. Clinicians could utilize it to prioritize high-risk patients for more invasive confirmatory tests.
Ethical and Psychological Considerations
Over diagnosis of indolent cancers can result in unnecessary treatments and increased anxiety for patients. It is crucial to establish clear guidelines for managing early-stage detections. Additionally, concerns regarding data privacy related to the storage and sharing of proteomic data need to be addressed.
Technological and Research Advancements
Achieving success in proteomics research could lead to increased investment, fostering innovation in the discovery of biomarkers and the development of personalized therapies. Nevertheless, the task of identifying dependable protein markers for rare cancers continues to pose significant challenges.
Health Equity Implications
Differences in access may worsen the current inequalities in cancer outcomes. It’s essential to ensure fair distribution and affordability to make a global impact.
Next Steps and Considerations
Novelna’s proteomics-based test has the potential to revolutionize cancer screening by allowing for earlier and less invasive detection of various cancers. However, its effectiveness in real-world applications depends on addressing challenges related to validation, cost, and ethics. It will be crucial for researchers, clinicians, policymakers, and ethicists to work together to maximize the benefits while minimizing the risks. Although the initial findings are promising, more research is needed to confirm the test’s effectiveness in larger and more diverse populations. Furthermore, incorporating this test into current healthcare systems will necessitate careful consideration of costs, accessibility, and education for both healthcare providers and patients. Still, Novelna’s proteomics-based test represents a significant advancement in the pursuit of early cancer detection.
References:
1. Budnik B, Amirkhani H, Forouzanfar MH, et al. Novel proteomics-based plasma test for early detection of multiple cancers in the general population. BMJ Oncology 2024; 3:e000073. Doi: 10.1136/ bmjonc-2023-000073
2. New Blood Test Detects 18 Types of Cancer in Early Stages, Study Finds, managed healthcare executive, 11 January 2024
3. Expert reaction to novel proteomics-based plasma test for early detection of multiple cancers, Science Media Centre, 09 January 2024
4. Gupta, S., Westacott, M.J., Ayers, D.G. et al. Plasma proteome of growing tumors. Sci Rep 13, 12195 (2023). https://doi.org/10.1038/s41598-023-38079-9
5. N. Leigh Anderson, Norman G. Anderson, The Human Plasma Proteome: History, Character, and Diagnostic Prospects, Molecular & Cellular Proteomics, Volume 1, Issue 11, 2002, Pages 845-867, https://doi.org/10.1074/mcp.R200007-MCP200
6. Hanash S, Taguchi A. Application of proteomics to cancer early detection. Cancer J. 2011 Nov-Dec; 17(6):423-8. Doi: 10.1097/PPO.0b013e3182383cab. PMID: 22157286; PMCID: PMC4318261.
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