Thrive Earlier Detection Announces Groundbreaking Clinical Data from the First Ever Interventional Study of a Blood-Based Test to Screen and Identify Multiple Types of Cancer

Findings Published in the Journal Science

Thrive Earlier Detection Corp., a company dedicated to extending and saving lives by incorporating earlier cancer detection into routine medical care, together with Johns Hopkins University and Geisinger Health, today announced data from the landmark DETECT-A study. DETECT-A (Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing) is the first ever prospective, interventional study to use a blood test to screen for multiple types of cancers in a real-world population.

Thrive Earlier Detection advises the study was conducted by Johns Hopkins University and Geisinger and enrolled more than 10,000 women with no prior history of cancer. The purpose was to identify multiple cancer types in asymptomatic individuals using an early version of CancerSEEK developed in 2016 (“Thrive’s blood test”). DETECT-A is the first study of a multi-cancer blood-based screening test to deliver results to physicians to manage patient care.

Cancer is the second leading cause of death in the United States with an estimated 600,000 people expected to die from the disease this year. Most of these cancers are often detected too late, and only after people start to experience symptoms. These “symptom-detected” cancers too frequently coincide with late stage, metastatic disease, and result in poor outcomes. However, when cancer is detected through screening, or are “screen-detected,” the disease is often identified earlier when it can be more effectively treated, and in many cases even cured. Unfortunately, current standard-of-care screening tests, like mammography and colonoscopy, only detect less than 30% of all incident cancers. The DETECT-A study provides the first real-world evidence that we can significantly shift the paradigm from “symptom-detected” cancers to more “screen-detected” cancers via a multi-cancer blood-based test.

The key findings from this prospective, interventional study demonstrate the following:

  • Thrive’s blood test identified cancers in individuals without any history of the disease.
  • Thrive’s blood test more than doubled the number of cancers that were first “screen-detected.” 25% of the women who were diagnosed with cancer were identified by current standard-of-care tests. By incorporating Thrive’s blood test, the percentage of “screen-detected” cancers increased from 25% to 52%.
  • Thrive’s blood test identified cancers across 10 different organs, seven of which currently have no standard-of-care screening.
  • Thrive’s blood test can identify cancers prior to clinically evident metastasis. 65% of the cancers identified were localized or regional.
  • Thrive’s blood test is additive and complementary to standard-of-care and was incorporated into routine medical care without discouraging patients from engaging in other forms of screening.
  • Thrive’s blood test, in combination with imaging, minimized false positive results with 99.6% specificity.
  • The study’s workflow (blood test plus imaging) safely guided clinical follow-up in blood test-positive participants with zero adverse events.

“This study is a seminal moment in cancer screening that advances the entire field,” said Christoph Lengauer, Ph.D., co-founder and chief innovation officer of Thrive. “For the first time, a blood test was utilized in a real-world setting and was able to more than double the number of cancers first identified through screening methods. We learned that it can be both complementary to existing standard-of-care screening tools, and a significant benefit for many types of cancers like ovarian, appendix and kidney, which do not have any current screening modalities.”

These data were published in Science and were presented today during the clinical plenary: Early Detection and CtDNA at the American Association for Cancer Research (AACR) Virtual Annual Meeting.

Prospective Interventional Study Design

The ability to identify multiple types of cancers through a blood draw is one of the most exciting advances in cancer diagnostics; however, prospective, interventional studies like DETECT-A are imperative to understand if a test can work in the real world. To date, retrospective and observational studies of blood-based multi-cancer tests have curated samples from participants who were already known to have cancer at the time of testing. Conversely, in DETECT-A, a prospective interventional study, participants were unaware of cancer at the time of enrollment and test results were reported to physicians and guided intervention.

DETECT-A enrolled 10,006 women with no prior history of cancer in a population with high adherence to standard-of-care cancer screening tests, such as mammography and colonoscopy. All participants were enrolled through the Geisinger Health System, enabling access to electronic medical records of participating individuals and minimizing loss to follow up.

DETECT-A utilized an early version of CancerSEEK that was developed in 2016, and analyzes 16 genes and nine proteins causatively linked to multiple types of cancer. Screening began with the analysis of a blood sample to identify potential abnormal values for at least one biomarker. Those with abnormal values were invited back for a confirmatory test to determine whether the identical biomarker was persistently abnormal and if appropriate, the individual was reviewed by a Multidisciplinary Review Committee. If a non-cancerous cause for the abnormal biomarker could not be identified, imaging was ordered. Patients with concerning imaging findings were referred to cancer specialists for further evaluation.

Study Results

Thrive’s blood test doubled the number of cancers first found through screening. Among the eligible participants, 96 women developed cancers: 26 of these were first identified by Thrive’s blood test, 24 were first identified by standard-of-care screening methods, and 46 were first identified by symptoms or other means. Thrive’s blood test detected cancers across ten different organs, including seven organs that do not have standard-of-care screening tools available. Notably, 65% of cancers detected by Thrive’s blood test were identified as local or regional disease, allowing for earlier intervention and if indicated, surgery with intent to cure. Thrive’s blood test’s sensitivity was 27.1% across all cancers and 31.1% for the seven cancers with no screening options. Importantly, Thrive’s blood test plus standard-of-care testing had a combined sensitivity of 52.1%, underscoring that a multi-cancer blood test is both a significant added benefit and complementary to standard-of-care screening tools.

Maintaining a high specificity thereby minimizing “false-positive” results is essential for a multi-cancer blood test. Screening with Thrive’s blood test alone had a 98.9% specificity, and when combined with imaging had a specificity of 99.6%. Thrive’s blood test plus imaging safely and efficiently guided clinical follow-up in blood test-positive participants with zero adverse events. Holistically, in this asymptomatic population with a cancer incidence of approximately 1%, Thrive’s blood test plus imaging resulted in a positive predictive value (PPV) of 40.6%, which is considerably higher than the PPV of existing single-cancer screening tests available today.

“Through this first-ever interventional study, the teams at Johns Hopkins University, Geisinger and Thrive have forged a new path and advanced the field of blood-based earlier cancer detection,” said David J. Daly, chief executive officer of Thrive. “Thrive is now one step closer to realizing our vision of providing a comprehensive approach to cancer screening, helping to shift the paradigm so that in the future, most cancers can be identified through earlier detection when there is the greatest opportunity for cure.”


Reference

1 Lennon et al. Science First Release, 2020

Hot this week

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”

Avery Dennison Medical Introduces Ipdated SilFoam Lite: Sustainability, MDR Certification & Performance Improvements

The newly enhanced SilFoam Lite delivers superior efficiency and reliability, bringing improved fluid handling capabilities and improved tack. These improvements make the product ideal for customers seeking quality, high-performance solutions in wound care notes Avery Dennison Medical.

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution

Axlab, Danish Medtech Pioneer, expands to US with Advanced Robotic Tissue Sectioning for Pathology Laboratories

Kris Rokke, National Sales Director for Axlab in the US. "My team and I are extremely excited and honored about this unique opportunity to also offer this advanced technology to labs across the US and thus contribute to the pathology labs of tomorrow."