MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Approximately 30 million men in the United States take the Prostate-Specific Antigen (PSA) screening test. Recent studies published in the Annals of Internal Medicine have established that PSA screenings have resulted in reduced mortality from prostate cancer. However, the problem with the PSA test is that many patients will receive indeterminate results. Only one in five of patients who have taken the test will have a positive biopsy for prostate cancer, but 33 percent of these patients could suffer from biopsy related side effects, and 1 percent will require hospitalization.
This study showed that the CellMax CTC blood test can predict which patients in the gray zone will need/have a positive prostate biopsy with a much lower false positive rate than current standard of care tests, potentially reducing unnecessary biopsies in this group by up to 90 percent. At the same time, the sensitivity of this test at 80 percent was comparable to the current standard of care tests, meaning this test was also accurate in ruling out biopsy in patients.
MedicalResearch.com: What should readers take away from your report?
Response: PSA-based screening for prostate cancer is beleaguered by false positives and typically result in more biopsies being prescribed. Men with indeterminate prostate screening results will soon have an affordable (the test will be priced around $150) and convenient blood test that they can take on a consistent basis to help inform whether they should undergo an invasive biopsy. We can better estimate treatment cost-savings from early cancer diagnosis
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: What recommendations do you have for future research as a result of this study? In Taiwan, this study is being expanded to 250 additional patients. In the United States, CellMax is collaborating with urologists at leading medical institutions to perform studies in the United States population.
MedicalResearch.com: Is there anything else you would like to add?
Response: CellMax Life plans to make this prostate cancer test available in the United States as a lab developed test from its CLIA and CAP accredited lab in Sunnyvale, California in 2018, at a sub $150 price point.
CellMax is also on the way to expedite a colorectal cancer early detection test and working with a number of other cancer diagnostics.
ASCO GU 2018 symposium presentation:
Prospective clinical study of a prostate cancer (PCa) rule-out blood test for PSA gray zone patients using a sensitive circulating tumor cell assay.
SEE-TONG Pang, Ying-Hsu Chang, Po-Hung Lin, Ying Chang, Drew Watson, Oscar Segurado, Si-Hong Lu, Jen-chia Wu, Jr-Ming Lai, Hung-Jen Shao, Shih-En Chang, Ben Hsieh, Mana Javey, Rui Mei; Chang Gung University and Hospital at LinKou, Taoyuan, Taiwan; Chang Gung Memorial Hospital, Taoyuan, Taiwan; Academia Sinica, Taipei, Taiwan; Kit Bio, Inc., Los Altos, CA; Medic Affairs Consulting LLC, San Jose, CA; CellMax Life, Sunnyvale, CA
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