29 Apr. 2020. A clinical trial enrolling some 10,000 women demonstrates the feasibility of a routine blood test to screen for multiple types of cancer in their early stages. The study was conducted by researchers at Johns Hopkins University that developed the test called Detect-A, and Geisinger health system, appearing in yesterday’s issue of the journal Science.
Detect-A is based on work at Johns Hopkins University in Baltimore by cancer researchers Bert Vogelstein, Kenneth Kinzler, and the paper’s senior author Nickolas Papadopoulos. The test analyzes circulating DNA, fragments of 16 genes broken off from tumors, as well as nine characteristic protein biomarkers or indicators of cancer, circulating in the blood stream. A paper published two years ago in Science showed an earlier version called CancerSEEK accurately detects 70 percent of tumors from eight types of cancer in half or more of 1,005 patients that had not yet begun to metastasize.
The new year-long study enrolled 10,006 women, clients of the Geisinger health system in Pennsylvania and New Jersey. Participants were age 65 to 75 with no prior history of cancer. The researchers enrolled only older women to look particularly for ovarian cancer, for which no standard screening test exists, as well as those at higher risk of cancer. The Geisinger health network also has an electronic health records system to capture medical histories of participants.
Blood samples from participants were screened by Detect-A, with abnormal concentrations of tumor DNA flagged for for more analysis. People with samples indicating possible cancer, were asked to give another blood sample for a second screening, looking for a repeat of the tumor DNA and excluding non-tumor mutations that can sometimes occur. Health records of individuals with tumor DNA in their blood confirmed by the second test were reviewed by an independent expert committee to rule out possible non-cancer causes, and where no such history was found, participants were asked to take a full body scan, using PET-CT imaging to confirm the cancer diagnosis and find the tumor’s location.
The results show Detect-A found cancer in 26 women, not detected with other methods including today’s standard screening procedures. Those standard procedures, such as mammograms detected cancer in 24 women, and 46 other cases were detected with other techniques. The researchers report the combination of blood tests and PET-CT scans returned a true positive rate of 99.6 percent. Moreover, the Detect-A process identified nine different solid tumor cancers, including ovarian cancer, usually detected today only in advanced stages.
The findings indicate Detect-A offers a feasible technique for early cancer screening. No adverse effects were reported and participants’ medical records show they were no less likely to use other screening procedures, such as mammograms, after providing blood samples than before the study. The researchers plan a longer-term study over five years and with a wider range of participants than customers of the Geisinger health system.
As reported by Science & Enterprise in May 2019, Vogelstein, Kinzler, and Papadopoulos are the scientific founders of Thrive Earlier Detection, a start-up enterprise in Cambridge, Massachusetts that licenses the Detect-A technology from Johns Hopkins. The company was formed by Christoph Lengauer, a partner at Third Rock Ventures, a science and technology venture capital company in Boston. Thrive also raised $110 million in its first venture funding at start-up.
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