Promising results showcase benefits of MCED lab tests and provide hope for continued advancements
In impressive new research, Johns Hopkins School of Medicine has developed a clinical laboratory blood test that detects the presence of cancer years before symptoms present, aiding physicians with early diagnosis and treatment.
The identification of cancer cells comes via bloodstream analysis showing genetic materials shed by tumors and showcases the promise of multicancer early detection screening (MCED) to spot all types of cancer in early stages.
“Three years earlier provides time for intervention. The tumors are likely to be much less advanced and more likely to be curable,” Yuxuan Wang, MD, PhD, lead researcher and assistant professor of oncology at Johns Hopkins, told SciTechDaily.
Kimmel Cancer Center, Ludwig Center, the Bloomberg School of Public Health also participated in the study with the support of the National Institutes of Health (NIH).
Senior study author Nickolas Papadopoulos, PhD, professor of oncology at Johns Hopkins School of Medicine and senior author of the study, notes that an appropriate course of clinical care will be required following any positive result from the new cancer diagnostic blood test. (Photo copyright: Johns Hopkins.)
Johns Hopkins Study Details
To complete their research, the scientists studied plasma samples that came from the NIH study on Atherosclerosis Risk in Communities (ARIC), which was created to examine cardiovascular disease risk factors in heart failure, strokes, and heart attacks, SciTechDaily reported.
The researchers analyzed the samples using “highly accurate and sensitive sequencing techniques to analyze blood samples from 26 participants in the ARIC study who were diagnosed with cancer within six months after sample collection, and 26 from similar participants who were not diagnosed with cancer, ” SciTechDaily noted.
At the time of sample gathering, eight of the study participants had received a positive score on the MCED test. Six of them provided additional blood samples dating back 3.1 to 3.5 years. Four of those samples showed mutations, SciTechDaily reported.
Value of MCED Screening
While the sample size in the Johns Hopkins study is small, results of the tests give patients and their physicians a head start on identifying appropriate treatments and demonstrate the strides already made with MCED screening.
MCED tests are relatively new, and while they continue to lack FDA-approval, their ability to discern various types of cancer and provide advanced detection with helpful results make them a promising approach to early cancer screening, the American Cancer Society (ACS) notes.
“For cancers of all stages, therapies are more effective with a lower disease burden,” the scientists wrote in Cancer Discovery.
MCED tests use blood, saliva, urine, or other body fluids to seek out cancer signs through RNA, DNA, or proteins from abnormal cells that may be cancerous. Current screening can assist with cervical, breast, colorectal, prostate, or lung cancer, the ACS added.
Spotting Cancer Earlier
The Johns Hopkins scientist believe detection beyond three years early is likely. “In four of these six participants, the same mutations detected by the multicancer early detection test could be identified, but at 8.6- to 79-fold lower mutant allele fractions. These results demonstrate that it is possible to detect [circulating tumor DNA] more than three years prior to clinical diagnosis and provide benchmark sensitivities required for this purpose,” the Cancer Discovery study notes.
“Detecting cancers years before their clinical diagnosis could help provide management with a more favorable outcome,” Nickolas Papadopoulos, PhD, professor of oncology at Johns Hopkins School of Medicine and senior author of the study, told SciTechDaily.
“Of course, we need to determine the appropriate clinical follow-up after a positive test for such cancers,” he added.
Executives and pathologists from many of the nation’s most prominent clinical laboratories are on their way to the Crescent City today to share best practices, hear case studies from innovative labs, and network
NEW ORLEANS—This afternoon, more than 900 lab CEOs, administrators, and pathologists will convene for the 28th Annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management conference. Three topics of great interest will center around adequate lab staffing, effective cost management, and developing new sources of lab testing revenue.
Important sessions will also address the explosion in next-generation sequencing and genetic testing, proposed FDA regulation of laboratory-developed tests (LDTs), and innovative ways that clinical laboratories and pathology groups can add value and be paid for that additional value.
All this is happening amidst important changes to healthcare and medicine in the United States. “Today, the US healthcare system is transforming itself at a steady pace,” explained Robert L. Michel, Editor-in-Chief of The Dark Report and Founder of the Executive War College. “Big multi-hospital health systems are merging with each other, and payers are slashing reimbursement for many medical lab tests, even as healthcare consumers want direct access to clinical laboratory tests and the full record of their lab test history.
“Each of these developments has major implications in how clinical laboratories serve their parent organizations, offer services directly to consumers, and negotiate with payers for fair reimbursement as in-network providers,” Michel added. “Attending the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management equips lab leaders with the tools they’ll need to make smart decisions during these challenging times.”
Now in its 28th year, the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management convenes April 25-26 in New Orleans. Executive War College extends to a third day with three full-day workshops: LEAN fundamentals for lab leaders, a genetic testing program track, and a digital pathology track. Learn more at www.ExecutiveWarCollege.com. (Photo copyright: The Dark Intelligence Group.)
Challenges and Opportunities for Clinical Laboratories
With major changes unfolding in the delivery and reimbursement of clinical services, clinical laboratory and pathology practice leaders need effective ways to respond to the evolving needs of physicians, patients, and payers. As The Dark Report has often covered, three overlapping areas are a source of tension and financial pressure for labs:
Day-to-day pressures to manage costs in the clinical laboratory or pathology practice.
The growing demand for genetic testing, accompanied by reimbursement challenges.
Evolving consumer expectations in how they receive medical care and interact with providers.
Addressing all three issues and much more, the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management features more than 80 sessions with up to 125 lab managers, consultants, vendors, and in vitro diagnostic (IVD) experts as speakers and panelists.
Old-School Lab Rules Have Evolved into New-School Lab Rules
Tuesday’s keynote general sessions (to be reported exclusively in Wednesday’s Dark Daily ebriefing) will include four points of interest for clinical laboratory and pathology leaders who are managing change and pursuing new opportunities:
Positioning the lab to prosper by serving healthcare’s new consumers, new care models, new payment models, and more, with Michel at the podium.
How old-school lab rules have evolved into new-school lab rules and ways to transition the lab through today’s disrupters in healthcare and the clinical laboratory marketplace, with Stan Schofield, Managing Principal of the Compass Group.
Generating value by identifying risk signals in longitudinal lab data and opportunities in big data from payers, physicians, pharma, and bioresearch, with Brad Bostic, Chairman and CEO of hc1.
Wednesday’s keynote sessions (see exclusive insights in Friday’s Dark Daily ebriefing) explore:
Wednesday’s keynotes conclude with a panel discussion on delivering value to physicians, patients, and payers with lab testing services.
Clinical Labs, Payers, and Health Plans Swamped by Genetic Test Claims
Attendees of the 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management may notice a greater emphasis on whole genome sequencing and genetic testing this year.
As regular coverage and analysis in The Dark Report has pointed out, clinical laboratories, payers, and health plans face challenges with the explosion of genetic testing. Several Executive War College Master Classes will explore critical management issues of genetic and genomic testing, including laboratory benefit management programs, coverage decisions, payer relations, and best coding practices, as well as genetic test stewardship.
This year’s Executive War College also devotes a one-day intensive session on how community hospitals and local labs can set up and offer genetic tests and next-generation sequencing services. This third-day track features more than a dozen experts including:
During these sessions, attendees will be introduced to “dry labs” and “virtual CLIA labs.” These new terms differentiate the two organizations that process genetic data generated by “wet labs,” annotate it, and provide analysis and interpretation for referring physicians.
State of the Industry: Clinical Lab, Private Practice Pathology, Genetic Testing, IVD, and More
For lab consultants, executives, and directors interested in state-of-the-industry Q/A and discussions concerning commercial laboratories, private-practice pathology, and in vitro diagnostics companies, a range of breakout sessions, panels, and roundtables will cover:
Action steps to protect pathologists’ income and boost practice revenue.
Important developments in laboratory legal, regulatory, and compliance requirements.
New developments in clinical laboratory certification and accreditation, including the most common deficiencies and how to reach “assessment ready” status.
An update on the IVD industry and what’s working in today’s post-pandemic market for lab vendors and their customers.
Federal government updates on issues of concern to clinical laboratories, including PAMA, the VALID Act, and more.
Long-time attendees will notice the inclusion of “Diagnostics” into the Executive War College moniker. It’s an important addition, Michel explained for Dark Daily.
“In the recent past, ‘clinical laboratory’ and ‘anatomic pathology’ were terms that sufficiently described the profession of laboratory medicine,” he noted. “However, a subtle but significant change has occurred in recent years. The term ‘diagnostics’ has become a common description for medical testing, along with other diagnostic areas such as radiology and imaging.”
Key managers of medical laboratories, pathology groups, and in vitro diagnostics have much to gain from attending the Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management, now in its 28th year. Look for continued coverage through social media channels, at Dark Daily, and in The Dark Report.
High rates of variability from one drop to another raise questions about the reliability of point of care testing equipment and companies that collect lab specimens only with finger sticks
In response, the embattled lab company in Palo Alto, Calif., has maintained that it is doing everything it can to correct any deficiencies in its clinical laboratory testing methods and to ensure its partners that its processes are scientifically sound and its methods valid. (more…)
Researchers determined that as many as nine successive capillary blood drops must be collected and tested to achieve results that would be comparable to testing with venous blood
A new study is raising questions about the implications of using fingerprick blood samples for point-of-care tests. Done by researchers at Rice University’s Department of Bioengineering, the study suggests clinicians use measurements with caution when assessing patients’ conditions based on the results of clinical laboratory tests using a single drop of capillary blood collected by fingerstick.
Pathologists and clinical laboratory scientists were quick to call attention to the study, based on the press release Rice University issued. That’s because, for almost 30 years, medical laboratories have struggled to correlate the results for such biomarkers as glucose. It is common for capillary blood specimen collected by finger stick and tested on a point-of-care device to produce different results for the same patient when compared with that of a venous specimen tested on the automated, high-volume analyzes in a central laboratory. The Rice researchers offer useful insights about such variation. (more…)
Analysis of almost 3 million newborn blood samples found that tens of thousands of specimens were not screened promptly for rare but deadly disorders, leading to patient harm in some cases
State-mandated newborn testing has come under increased media scrutiny following the discovery that delays in reporting the clinical laboratory test results had resulted in harm to some children with genetic diseases. One source of problems is some hospitals fail to promptly submit specimens from babies to their state’s newborn testing laboratory.
In Wisconsin, pathologists and medical laboratory and laboratory managers probably know the story of Colton Hidde because of news stories about his case. When Karen and Mike Hidde brought their newborn baby Colton home from the hospital after his birth in October 2012, they had no idea that he would soon be close to death. He appeared to be a normal newborn. But he was not, and the Hiddes didn’t find out that he had a rare and life-threatening genetic defect until they rushed him back to the hospital less than 24 hours after bringing him home. (more…)
