By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies
Diagnostics took three of 10 top spots on the Cleveland Clinic’s list of anticipated breakthrough medical innovations for 2016. In some cases, the technologies to watch—cancer screening via protein biomarker analysis, cell-free fetal DNA testing, genomics-based clinical trials—have already entered either the clinical market or late trials, but the Cleveland Clinic anticipates significant advancement in adoption in the upcoming year.
This is the 10th year that the Cleveland Clinic created its annual listing of the 10 most powerful medical innovations of the coming year. A panel of 75 Cleveland Clinic physicians and scientists selects the breakthrough drug therapies, medical devices, and public health initiatives. This year’s top 10 were narrowed from 246 potential candidates.
#6 – Cancer Screening via Protein Biomarker Analysis
Cancer screening and monitoring have focused on measuring a single protein concentration in blood or urine (think CA-125 for ovarian cancer or prostate specific antigen for prostate cancer). These single measurements, the Cleveland Clinic says, have limited diagnostic accuracy. The clinic anticipates smarter screening strategies to emerge based on biomarker platforms capable of evaluating changes in the structure of certain proteins. By evaluating structural isoforms of protein biomarkers, new technologies will be able to differentiate proteins produced by cancer cells versus normal cells. The Cleveland Clinic says early results are “promising” with good diagnostic accuracy for a broad spectrum of cancers.
“In contrast to examining genetic mutations, which can indicate the risk of cancer, the new tests give real-time information on cancer’s presence,” the Cleveland Clinic said in a video series accompanying the announcement of the top 10.
#5 – Cell-Free Fetal DNA Testing
Clinicians have long sought information regarding the chance that a fetus has an aneuploidy—either missing or extra chromosomes. Blood tests and ultrasound imaging have historically had high rates of false-positives, while chorionic villus sampling and amniocentesis have improved accuracy but carry a small risk of fetal harm given the invasive nature of the test sampling. Ninety percent of invasive testing is not needed, the Cleveland Clinic says, as a result of cell-free fetal DNA testing.
Noninvasive prenatal testing, which utilizes cell-free fetal DNA circulating in the maternal blood stream, has been commercially available for several years now and accurately predicts Down’s and Edward’s syndromes. While noninvasive prenatal testing is currently only recommended for high-risk pregnancies, the clinic expects this testing will soon be “widely available.”
#2 – Genomics-Based Clinical Trials
Genomic-based clinical trials are not entirely new. The National Cancer Institute’s NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) Trial kicked-off this year and the Lung Cancer Master Protocol (Lung-MAP) trial launched in 2014. Wider initiation of these types of trials, the Cleveland Clinic says, will increase the chances that patients with advanced cancers or rare diseases will benefit from experimental therapies.
“Patients are waiting too long to enter clinical trials for drugs that may or may not be effective for their specific variation of cancer,” says Charis Eng, M.D., Ph.D., chair of the Cleveland Clinic Genomic Institute, in a statement. “End-stage cancer patients especially may not have that time.”
The clinic says in its video announcements that the gold standard of randomized controlled trials are ‘inadequate” for assessing targeted therapies. Further advancement of genomic-based trials will not only benefit enrolled patients, but will also speed development and commercialization of targeted therapies.