SEEK and ye shall find

CAMBRIDGE, Mass.—Cancer, the second leading cause of death in the United States, may claim the lives of 600,000 people in 2020. Most cancers are detected too late, after people experience symptoms in late-stage, metastatic disease. Cancer detection by screening identifies the disease earlier, enabling more effective treatment and possible cure. Today’s standard tests, such as mammography and colonoscopy, detect less than 30 percent of all incident cancers.

 

But a landmark study offers real-world evidence on perhaps shifting the paradigm from “symptom-detected” cancers to more “screen-detected” cancers with a multicancer blood-based test.

 

Thrive Earlier Detection Corp., which attempts to extend and save lives by incorporating earlier cancer detection into routine medical care, along with Johns Hopkins University and Geisinger Health, announced data from the DETECT-A study (Detecting cancers Earlier Through Elective mutation-based blood Collection and Testing), which they say is the first prospective, interventional study to use a blood test to screen for multiple types of cancers in a real-world population.

 

Conducted by Johns Hopkins University and Geisinger, the study enrolled more than 10,000 women with no prior history of cancer to identify multiple cancer types in asymptomatic individuals using an early version of CancerSEEK, developed in 2016 by Thrive. DETECT-A is the first study of a multicancer blood-based screening test to deliver results to physicians to manage patient care. Results were published in Science and were presented during the clinical plenary, “Early Detection and CtDNA,” at the American Association for Cancer Research (AACR) Virtual Annual Meeting.

 

According to Dr. Christoph Lengauer, co-founder and chief innovation officer of Thrive, “This study is a seminal moment in cancer screening that advances the entire field. 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.”

 

Lengauer noted that the CancerSEEK technology was developed by three of the company’s co-founders—Bert Vogelstein, Ken Kinzler and Nick Papadopoulos—at Johns Hopkins University. The Vogelstein Lab has pioneered the field of cancer genomics over the last 30-plus years and is the core of Thrive’s scientific efforts, he added.

 

CancerSEEK is a multi-analyte blood test that analyzes circulating tumor DNA across 16 genes, along with expression levels for nine protein biomarkers that have been carefully curated and are common links to cancer. A machine-learning classifier is applied to determine whether a patient has cancer.

 

“CancerSEEK is fundamentally different since it is intended to detect multiple types of cancer through a blood test versus looking at one cancer type at a time using other methods,” Lengauer explained. “It is important to note, however, that CancerSEEK is intended to be both an added benefit and complementary to standard-of-care screening tests, such as mammograms and colonoscopies. Since CancerSEEK is a novel approach to be used to detect multiple types of cancer in otherwise healthy adults, it emphasizes high specificity—enabling a lower false-positive rate than standard screening tools—to give physicians confidence in next steps and minimize unnecessary follow-up procedures.”

 

Thrive has not disclosed a timeframe for broad market access. The next step is to finalize trial design with the FDA and then initiate the trial.

 

Lengauer remarks that the clinical trial results lived up to the company’s expectations. As he stated, “DETECT-A was a landmark study, since it was the first time a blood test was utilized in an interventional, prospective study to detect multiple types of cancer. The goals of the study were: to detect cancers not found by standard of care in a real-world population; to have the pilot blood test and workflow in a large clinical population; and to manage patient care by delivering test results. This is the first time results of a multicancer blood test were delivered back to the patient and physician to administer treatment. We achieved all of the goals set forth in the study and were able to safely more than double the number of cancers detected in this population through screening methods.”

 

Lengauer concluded, “Our ultimate goal is to make our test a routine part of medical care for average-risk adults. We envision a future where routine preventative care includes a blood test for cancer, just as patients are now routinely tested for early stages of heart disease. We know that every Stage 4 cancer starts as a Stage 1 cancer, and if cancer is caught early enough, it is often effectively treated or even cured.”