5:00 – 5:45 PM Early Diagnosis Through Predictive Biomarkers, NonInvasive Testing
Reporter: Stephen J. Williams, Ph.D.
Diagnosing cancer early is often the difference between survival and death. Hear from experts regarding the new and emerging technologies that form the next generation of cancer diagnostics.
Moderator: Heather Rose, Director of Licensing, Thomas Jefferson University
Speakers:
Bonnie Anderson, Chairman and CEO, Veracyte @BonnieAndDx
Kevin Hrusovsky, Founder and Chairman, Powering Precision Health @KevinHrusovsky
Bonnie Anderson and Veracyte produces genomic tests for thyroid and other cancer diagnosis. Kevin Hrusovksy and Precision Health uses peer reviewed evidence based medicine to affect precision medicine decision.
Bonnie: aim to get a truth of diagnosis. Getting tumor tissue is paramount as well as properly preserved tissue. They use deep RNA sequencing and machine learning in their clinically approved tests.
Kevin: Serial biospace entrepreneur. Two diseases, cancer and neurologic, have been diseases which have been hardest to get reproducible and validated biomarkers of early disease. He concentrates on protein biomarkers.
Heather: FDA has recently approved drugs for early disease intervention. However the use of biomarkers can go beyond patient stratification in clinical trials.
Kevin: 15 approved drugs for MS but the markers are scans looking for brain atrophy which is too late of an endpoint. So we need biomarkers of early disease progression. We can use those early biomarkers of disease progression so pharma can target those early biomarkers and or use those early biomarkers of disease progression for endpoint
Bonnie: exciting time in the early diagnostics field. She prefers transcriptomics to DNA based methods such as WES or WGS (whole exome or whole genome sequencing). It was critical to show data on the cost savings imparted by their transcriptomic based thryoid cancer diagnostic test for payers to consider this test eligible for reimbursement.
Kevin: There has been 20 million CAT scans for cancer but it is estimated 90% of these scans led to misdiagnosis. Biomarker development has revolutionized diagnostics in this disease area. They have developed a breakthrough panel of ten protein biomarkers in serum which he estimates may replace 5 million mammograms.
All panelists agreed on the importance of regulatory compliance and the focus of new research should be on early detection. In addition they believe that Dr. Gotlieb’s appointment to the FDA is a positive for the biomarker development field, as Dr. Gotlieb understands the potential and importance of early detection and prevention of disease. Kevin also felt Dr. Gotlieb understands the importance of incorporating biomarkers as endpoints in clinical trials. Over 750 phase 1,2, and 3 clinical trials use biomarker endpoints but the pharma companies still need to prove the biomarkers clinical relevance to the FDA.They also agreed it would be helpful to involve advocacy groups in putting more pressure on the healthcare providers and policy makers on this importance of diagnostics as a preventative measure.
In addition, the discovery and use of biomarkers as disease endpoints has led to a resurgence of Alzheimer’s disease drug development by companies which have previously given up on these type of neurodegenerative diseases.
Kevin feels proteomics offers great advantages over DNA-based diagnostics, especially in cancer such as ovarian cancer, where a high degree of specificity for a diagnostic test is required to ascertain if a woman should undergo prophylactic oophorectomy. He suggests that a new blood-based protein biomarker panel is being developed for early detection of some forms of ovarian cancer.
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This is very insightful. There is no doubt that there is the bias you refer to. 42 years ago, when I was postdocing in biochemistry/enzymology before completing my residency in pathology, I knew that there were very influential mambers of the faculty, who also had large programs, and attracted exceptional students. My mentor, it was said (although he was a great writer), could draft a project on toilet paper and call the NIH. It can’t be true, but it was a time in our history preceding a great explosion. It is bizarre for me to read now about eNOS and iNOS, and about CaMKII-á, â, ã, ä – isoenzymes. They were overlooked during the search for the genome, so intermediary metabolism took a back seat. But the work on protein conformation, and on the mechanism of action of enzymes and ligand and coenzyme was just out there, and became more important with the research on signaling pathways. The work on the mechanism of pyridine nucleotide isoenzymes preceded the work by Burton Sobel on the MB isoenzyme in heart. The Vietnam War cut into the funding, and it has actually declined linearly since.
A few years later, I was an Associate Professor at a new Medical School and I submitted a proposal that was reviewed by the Chairman of Pharmacology, who was a former Director of NSF. He thought it was good enough. I was a pathologist and it went to a Biochemistry Review Committee. It was approved, but not funded. The verdict was that I would not be able to carry out the studies needed, and they would have approached it differently. A thousand young investigators are out there now with similar letters. I was told that the Department Chairmen have to build up their faculty. It’s harder now than then. So I filed for and received 3 patents based on my work at the suggestion of my brother-in-law. When I took it to Boehringer-Mannheim, they were actually clueless.