Can Theranos resurrect from its ashes?
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Miyo K. Chatanaka
,
Eleftherios P. Diamandis
und
Mario Plebani
Abstract
Theranos was a biotechnology company which, in the 2010s, promised to revolutionize traditional clinical chemistry testing by using novel technology, microvolumes of blood obtained by finger pricks, and performance of tests outside traditional clinical chemistry laboratories, such as in pharmacies. Theranos did not publish any details of their technology, nor sought to evaluate it independently. Despite this, it attracted millions of dollars of investments, and at a point, its market valuation reached $9 billion. Around 2015 the Theranos business practices and technology were scrutinized and it was revealed that they misled investors, doctors, and patients by falsely claiming of using their own technology, when in fact, they were using traditional clinical chemistry analyzers. The leaders of Theranos are now serving prison time. This year it was announced that a new effort is underway, by people who are related to Theranos, to start a new company, with objectives that partially overlap with those of the old company. Here, we comment on these new developments, with the hope that the lessons learned from the past will guide the new leaders to find success while mentioning that some new developments in the field will likely pose formidable competition.
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Research ethics: Not applicable.
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Informed consent: Not applicable.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission. MKC and MP edited the manuscript. EPD drafted and conceptualized the manuscript.
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Use of Large Language Models, AI and Machine Learning Tools: None declared.
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Conflict of interest: Authors state no conflict of interest.
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Research funding: None declared.
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Data availability: Not applicable.
References
1. Diamandis, EP. Theranos phenomenon: promises and fallacies. Clin Chem Lab Med 2015;53:989–93. https://doi.org/10.1515/cclm-2015-0356.Suche in Google Scholar PubMed
2. Li, M, Diamandis, EP. Theranos promises a new era of preventive health care - but where’s the physician? Clin Biochem 2015;48:1027. https://doi.org/10.1016/j.clinbiochem.2015.09.005.Suche in Google Scholar PubMed
3. Li, M, Diamandis, EP. Theranos phenomenon - part 2. Clin Chem Lab Med 2015;53:1911–2. https://doi.org/10.1515/cclm-2015-0775.Suche in Google Scholar PubMed
4. Li, M, Diamandis, EP. Theranos phenomenon - part 3. Clin Chem Lab Med 2016;54:e145–146. https://doi.org/10.1515/cclm-2016-0107.Suche in Google Scholar PubMed
5. Diamandis, EP. Theranos phenomenon - part 4: Theranos at an International Conference. Clin Chem Lab Med 2016;54:e243–4. https://doi.org/10.1515/cclm-2016-0389.Suche in Google Scholar PubMed
6. Diamandis, EP, Plebani, M. Theranos phenomenon - part 5: Theranos’ presentation at the American Association for Clinical Chemistry Annual Conference 2016. Clin Chem Lab Med 2016;54:e313–314. https://doi.org/10.1515/cclm-2016-0737.Suche in Google Scholar PubMed
7. Fiala, C, Diamandis, EP. Theranos: almost complete absence of laboratory medicine input. J Appl Lab Med. 2019;3:749–52. https://doi.org/10.1373/jalm.2018.027474.Suche in Google Scholar PubMed
8. Diamandis, EP, Lackner, KJ, Plebani, M. Theranos revisited: the trial and lessons learned. Clin Chem Lab Med 2022;60:4–6. https://doi.org/10.1515/cclm-2021-0994.Suche in Google Scholar PubMed
9. Diamandis, EP. Please do not call it Theranos. Clin Chem Lab Med 2023;61:e103–4. https://doi.org/10.1515/cclm-2023-0110.Suche in Google Scholar PubMed
10. Fiala, C, Diamandis, EP. The meteoric rise and dramatic fall of Theranos: lessons learned for the diagnostic industry. Clin Chem Lab Med 2018;56:1443–6. https://doi.org/10.1515/cclm-2018-0353.Suche in Google Scholar PubMed
11. Li, M, Diamandis, EP. Technology-driven diagnostics: from smart doctor to smartphone. Crit Rev Clin Lab Sci 2016;53:268–76. https://doi.org/10.3109/10408363.2016.1149689.Suche in Google Scholar PubMed
12. Ioannidis, JPA. Stealth research: is biomedical innovation happening outside the peer-reviewed literature? J Am Med Assoc 2015;313:663–4. https://doi.org/10.1001/jama.2014.17662.Suche in Google Scholar PubMed
13. Carreyrou, J. Bad blood: secrets and lies in a Silicon Valley startup. New York: Knopf; 2018.Suche in Google Scholar
14. Ren, AH, Diamandis, EP, Kulasingam, V. Uncovering the depths of the human proteome: antibody-based technologies for ultrasensitive multiplexed protein detection and quantification. Mol Cell Proteomics 2021;20:100155. https://doi.org/10.1016/j.mcpro.2021.100155.Suche in Google Scholar PubMed PubMed Central
15. Topol, EJ. The revolution in high-throughput proteomics and AI. Science 2024;385:eads5749. https://doi.org/10.1126/science.ads5749.Suche in Google Scholar PubMed
16. Schmidt, C. Leroy Hood looks forward to P4 medicine: predictive, personalized, preventive, and participatory. J Natl Cancer Inst 2014;106:dju416. https://doi.org/10.1093/jnci/dju416.Suche in Google Scholar PubMed
17. Fiala, C, Diamandis, EP. P4 medicine or O4 medicine? The perils of population wide, asymptomatic disease screening. Clin Biochem 2020;77:62. https://doi.org/10.1016/j.clinbiochem.2020.01.002.Suche in Google Scholar PubMed
18. Fiala, C, Taher, J, Diamandis, EP. P4 medicine or O4 medicine? Hippocrates provides the answer. J Appl Lab Med 2019;4:108–19. https://doi.org/10.1373/jalm.2018.028613.Suche in Google Scholar PubMed
19. Fiala, C, Diamandis, EP. The outcomes of scientific debates should be published: the Arivale story. J Appl Lab Med 2020;5:1070–5. https://doi.org/10.1093/jalm/jfaa110.Suche in Google Scholar PubMed
20. Smith, DG. Would you pay $20,000 to try to live longer? N Y Times 2025. https://www.nytimes.com/2025/01/22/well/longevity-health-clinics.html [Accessed 27 May 2025].Suche in Google Scholar
21. Wilson, JMG, Jungner, G, Organization, WH. Principles and practice of screening for disease; 1968. https://iris.who.int/handle/10665/37650 [Accessed 27 May 2025].Suche in Google Scholar
22. Chatanaka, MK, Diamandis, EP. Arivale is dead - hooke is alive. Clin Chem Lab Med. 2025;63:e227–8. https://doi.org/10.1515/cclm-2025-0443Suche in Google Scholar PubMed
23. Bretthauer, M, Wieszczy, P, Løberg, M, Kaminski, MF, Werner, TF, Helsingen, LM, et al.. Estimated lifetime gained with cancer screening tests: a meta-analysis of randomized clinical trials. JAMA Internal Med 2023;183:1196–203. https://doi.org/10.1001/jamainternmed.2023.3798.Suche in Google Scholar PubMed PubMed Central
24. Chatanaka, MK, Diamandis, EP. What does cancer screening have to do with tomato growing? Clin Chem Lab Med 2025;6.10.1515/cclm-2024-1408Suche in Google Scholar PubMed
25. Allyn, B. Elizabeth Holmes’ partner raises millions for new biotech testing startup. NPR; 2025. https://www.npr.org/2025/05/10/nx-s1-5393950/elizabeth-holmes-theranos-billy-evans-blood-testing [Accessed 27 May 2025].Suche in Google Scholar
26. Hou, C, Xie, F, Yu, W, Wu, G, Yang, H, Yang, L, et al.. Breast cancer early detection and molecular subtype prediction by combination of Raman spectroscopy with deep learning. Spectrochim Acta Mol Biomol Spectrosc 2025;341:126396. https://doi.org/10.1016/j.saa.2025.126396.Suche in Google Scholar PubMed
© 2025 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Editorial
- Quality indicators: an evolving target for laboratory medicine
- Reviews
- Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine
- The spectrum of nuclear patterns with stained metaphase chromosome plate: morphology nuances, immunological associations, and clinical relevance
- Opinion Papers
- Comprehensive assessment of medical laboratory performance: a 4D model of quality, economics, velocity, and productivity indicators
- Detecting cardiac injury: the next generation of high-sensitivity cardiac troponins improving diagnostic outcomes
- Perspectives
- Can Theranos resurrect from its ashes?
- Guidelines and Recommendations
- Australasian guideline for the performance of sweat chloride testing 3rd edition: to support cystic fibrosis screening, diagnosis and monitoring
- General Clinical Chemistry and Laboratory Medicine
- Recommendations for the integration of standardized quality indicators for glucose point-of-care testing
- A cost-effective assessment for the combination of indirect immunofluorescence and solid-phase assay in ANA-screening
- Assessment of measurement uncertainty of immunoassays and LC-MS/MS methods for serum 25-hydroxyvitamin D
- A novel immunoprecipitation-based targeted liquid chromatography-tandem mass spectrometry analysis for accurate determination for copeptin in human serum
- Histamine metabolite to basal serum tryptase ratios in systemic mastocytosis and hereditary alpha tryptasemia using a validated LC-MS/MS approach
- Machine learning algorithms with body fluid parameters: an interpretable framework for malignant cell screening in cerebrospinal fluid
- Impact of analytical bias on machine learning models for sepsis prediction using laboratory data
- Immunochemical measurement of urinary free light chains and Bence Jones proteinuria
- Serum biomarkers as early indicators of outcomes in spontaneous subarachnoid hemorrhage
- High myoglobin plasma samples risk being reported as falsely low due to antigen excess – follow up after a 2-year period of using a mitigating procedure
- Candidate Reference Measurement Procedures and Materials
- Commutability evaluation of glycated albumin candidate EQA materials
- Reference Values and Biological Variations
- Health-related reference intervals for heavy metals in non-exposed young adults
- Hematology and Coagulation
- Practical handling of hemolytic, icteric and lipemic samples for coagulation testing in European laboratories. A collaborative survey from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM)
- Cancer Diagnostics
- Assessment of atypical cells in detecting bladder cancer in female patients
- Cardiovascular Diseases
- False-positive cardiac troponin I values due to macrotroponin in healthy athletes after COVID-19
- Diabetes
- A comparison of current methods to measure antibodies in type 1 diabetes
- Letters to the Editor
- The neglected issue of pyridoxal- 5′ phosphate
- Error in prostate-specific antigen levels after prostate cancer treatment with radical prostatectomy
- Arivale is dead ‒ Hooke is alive
- A single dose of 20-mg of ostarine is detectable in hair
- Growing importance of vocabularies in medical laboratories
- Congress Abstracts
- 62nd National Congress of the Hungarian Society of Laboratory Medicine Szeged, Hungary, August 28–30, 2025
Artikel in diesem Heft
- Frontmatter
- Editorial
- Quality indicators: an evolving target for laboratory medicine
- Reviews
- Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine
- The spectrum of nuclear patterns with stained metaphase chromosome plate: morphology nuances, immunological associations, and clinical relevance
- Opinion Papers
- Comprehensive assessment of medical laboratory performance: a 4D model of quality, economics, velocity, and productivity indicators
- Detecting cardiac injury: the next generation of high-sensitivity cardiac troponins improving diagnostic outcomes
- Perspectives
- Can Theranos resurrect from its ashes?
- Guidelines and Recommendations
- Australasian guideline for the performance of sweat chloride testing 3rd edition: to support cystic fibrosis screening, diagnosis and monitoring
- General Clinical Chemistry and Laboratory Medicine
- Recommendations for the integration of standardized quality indicators for glucose point-of-care testing
- A cost-effective assessment for the combination of indirect immunofluorescence and solid-phase assay in ANA-screening
- Assessment of measurement uncertainty of immunoassays and LC-MS/MS methods for serum 25-hydroxyvitamin D
- A novel immunoprecipitation-based targeted liquid chromatography-tandem mass spectrometry analysis for accurate determination for copeptin in human serum
- Histamine metabolite to basal serum tryptase ratios in systemic mastocytosis and hereditary alpha tryptasemia using a validated LC-MS/MS approach
- Machine learning algorithms with body fluid parameters: an interpretable framework for malignant cell screening in cerebrospinal fluid
- Impact of analytical bias on machine learning models for sepsis prediction using laboratory data
- Immunochemical measurement of urinary free light chains and Bence Jones proteinuria
- Serum biomarkers as early indicators of outcomes in spontaneous subarachnoid hemorrhage
- High myoglobin plasma samples risk being reported as falsely low due to antigen excess – follow up after a 2-year period of using a mitigating procedure
- Candidate Reference Measurement Procedures and Materials
- Commutability evaluation of glycated albumin candidate EQA materials
- Reference Values and Biological Variations
- Health-related reference intervals for heavy metals in non-exposed young adults
- Hematology and Coagulation
- Practical handling of hemolytic, icteric and lipemic samples for coagulation testing in European laboratories. A collaborative survey from the European Organisation for External Quality Assurance Providers in Laboratory Medicine (EQALM)
- Cancer Diagnostics
- Assessment of atypical cells in detecting bladder cancer in female patients
- Cardiovascular Diseases
- False-positive cardiac troponin I values due to macrotroponin in healthy athletes after COVID-19
- Diabetes
- A comparison of current methods to measure antibodies in type 1 diabetes
- Letters to the Editor
- The neglected issue of pyridoxal- 5′ phosphate
- Error in prostate-specific antigen levels after prostate cancer treatment with radical prostatectomy
- Arivale is dead ‒ Hooke is alive
- A single dose of 20-mg of ostarine is detectable in hair
- Growing importance of vocabularies in medical laboratories
- Congress Abstracts
- 62nd National Congress of the Hungarian Society of Laboratory Medicine Szeged, Hungary, August 28–30, 2025
