News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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United Kingdom’s National Health Service Now Offers Liquid Biopsy Tests to Certain Cancer Patients as a Complement to Anatomic Pathology Testing

Decision is part of UK effort to diagnose 75% of all cancers at stage I or stage II by 2028 and demonstrates to pathologists that the technology used in liquid biopsy tests is improving at a fast pace

Pathologists and medical laboratory scientists know that when it comes to liquid biopsy tests to detect cancer, there is plenty of both hope and hype. Nevertheless, following a successful pilot study at the Christie NHS Foundation Trust in Manchester, England, which ran from 2015-2021, the UK’s National Health Service (NHS) is pushing forward with the use of liquid biopsy tests for certain cancer patients, The Guardian reported.

NHS’ decision to roll out the widespread use of liquid biopsies—a screening tool used to search for cancer cells or pieces of DNA from tumor cells in a blood sample—across the UK is a hopeful sign that ongoing improvements in this diagnostic technology are reaching a point where it may be consistently reliable when used in clinical settings.

The national program provides personalized drug therapies based on the genetic markers found in the blood tests of cancer patients who have solid tumors and are otherwise out of treatment options. The liquid biopsy creates, in essence, a match-making service for patients and clinical trials.

Liquid Biopsy Genetic Testing for Cancer Patients

“The learnings from our original ‘Target’ study in Manchester were that genetic testing needs to be done on a large scale to identify rare genetic mutations and that broader access to medicines through clinical trials being undertaken across the country rather than just one site are required,” Matthew Krebs, PhD, Clinical Senior Lecturer in Experimental Cancer Medicine at the University of Manchester, told The Guardian.

Krebs, an honorary consultant in medical oncology at the Christie NHS Foundation Trust, led the Target National pilot study.

“This study will allow thousands of cancer patients in the UK to access genetic testing via a liquid biopsy. This will enable us to identify rare genetic mutations that in some patients could mean access to life-changing experimental medicines that can provide great treatment responses, where there are otherwise limited or no other treatment options available.”

Detecting cancers at earlier stages of disease—when treatment is more likely to result in improved survival—has become a strategic cancer planning priority in the UK, theBMJ noted.

“The NHS is committed to diagnosing 75% of all cancers at stage I or II by 2028, from around 50% currently,” the BMJ wrote. “Achieving such progress in less than a decade would be highly ambitious, even without disruption caused by the COVID-19 pandemic. In this context, considerable hope has been expressed that blood tests for circulating free DNA—sometimes known as liquid biopsy—could help achieve earlier detection of cancers.”

The Guardian noted that the UK’s initiative will use a liquid biopsy test made by Swiss-healthcare giant Roche.

 Matthew Krebs, PhD
“We can’t guarantee that we will find a fault in the genetic code of every cancer patient we recruit, or that if we do, there will be a suitable drug trial for them,” Matthew Krebs, PhD (above), lead scientist of the NHS’ Target National pilot study, told The Guardian. “However, as we learn more about the genetics of cancer in this study, it will help doctors and scientists develop new treatments to help people in the future. Ultimately, we hope liquid biopsy testing will be adopted into routine NHS care, but we need studies such as this to show the benefit of the test on a large scale and provide the evidence that patients can benefit from being matched to targeted medicines on the basis of the blood test.” (Photo copyright: Cancer Research UK Manchester Centre.)

Liquid Biopsies: Hope or Hype?

In 2020, the US Food and Drug Administration (FDA) expanded its clearance for two liquid biopsy tests in this country—Guardant Health’s Guardant360 CDx and Foundation Medicine’s FoundationOne Liquid CDx—for use as companion diagnostic tests and for general tumor profiling for certain non-small cell lung, prostate, breast, and ovarian cancers, according to an NIH National Cancer Institute news release.

In her article “The Promise of Liquid Biopsies for Cancer Diagnosis,” published in the American Journal of Managed Care (AJMC) Evidence-based Oncology, serial healthcare entrepreneur and faculty lecturer at Harvard Medical School Liz Kwo, MD, detailed the optimism surrounding the “revolutionary screening tool,” including its potential for:

  • providing earlier diagnose of cancer,
  • customizing treatment through genotyping,
  • identifying mechanisms of resistance to therapies,
  • measuring remaining disease after treatment,
  • assessing cancer relapse or resistance to treatment, and
  • eliminating risk surrounding traditional biopsies.

The AJMC article estimated the liquid biopsy market will be valued at $6 billion by 2030. However, Kwo also noted that clinical adoption of liquid biopsies in the US continues to face challenges.

In a STAT editorial, titled, “Liquid Biopsy: Misplaced Faith in Early Cancer Detection?H. Gilbert Welch, MD, a Harvard University academic physician and cancer researcher, voiced concerns about widespread use of liquid biopsies for cancer screening.

Welch compared the investor hype surrounding liquid biopsies to that of the now-defunct blood testing company Theranos, which lured high-profile investors to pour millions into its unproven diagnostic technology.

“Effective cancer screening requires more than early detection. It also requires that starting therapy earlier helps people live to older ages than they would if they started treatment later,” he wrote. “If that doesn’t happen, liquid biopsies will only lead to people living longer with the knowledge they have a potentially incurable disease without extending their lives. These people would be subjected to cancer therapies and their toxicities earlier, but at a time when they would otherwise be experiencing no cancer-related signs or symptoms.”

And so, while there’s much excitement about the possibility of a minimally invasive way to detect cancer, anatomic pathology groups and clinical laboratories will have to wait and see if the hype and hope surrounding liquid biopsies is substantiated by further research.

Andrea Downing Peck

Related Information:

NHS Cancer Patients to Get Pioneering Genetic Test to Find Best Treatments

‘Liquid Biopsy’ for Cancer Screening

The Promise of Liquid Biopsies for Cancer Diagnosis

Cancer ‘Liquid Biopsy’ Blood Test Gets Expanded FDA Approval

Liquid Biopsy: Misplaced Faith in Early Cancer Detection?

Leapfrog Group CEO Wants Healthcare Professionals to Stop Rallying Behind Quality Measure Critics

Binder argues that groups opposing ‘value’ often diminish clinicians’ role in hospital quality and patient outcomes; clinical labs often have the data on the outcomes generated by different clinicians

As healthcare moves steadily toward a value-based reimbursement model, Leapfrog Group CEO Leah Binder is urging healthcare providers to rethink their opposition to quality measures and criteria that reward improved medical outcomes.

“Clinicians have a choice: Seize the momentum of the value movement to finally get rewarded for excellence, or recite tired political talking points that minimize your life’s work,” Binder stated in an editorial she penned for Modern Healthcare. “Value will succeed either way, but it will be so much better infused with the knowledge and gifts of practicing providers.”

Many clinical laboratory managers and pathologists know that the Leapfrog Group carries quite a bit of clout in healthcare. Its members include some of the largest corporations in the United States. Collectively, Leapfrog’s members provide health benefits to more than 37 million Americans in all 50 states, and spend tens of billions of dollars on healthcare each year, according to this 2009 Leapfrog Group Fact Sheet. This is why health insurers, hospitals, and physicians pay attention to Leapfrog’s programs and public statements.

“If all hospitals implemented just the first three of Leapfrog’s four ‘leaps’ (our recommended quality and safety practices): over 57,000 lives could be saved, more than 3 million medication errors could be avoided, and up to $12.0 billion could be saved each year,” states the fact sheet.

Physician Opposition to Value-based Reimbursement Models Will Backfire

Leapfrog’s Binder argues the value-based reimbursement movement will succeed for three reasons:

1. “Value” is enshrined in the Affordable Care Act, with the Centers for Medicare and Medicaid Services (CMS) now tying almost 6% of hospital Medicare reimbursement to performance, and Congress replacing the sustainable growth-rate (SGR) with a value-based formula.

2. Private insurers also are transitioning their payment models, with 40% of commercial payments linked to value, up from 9% a year earlier. In addition, consumers, who are paying more out of pocket, are increasingly sensitive to value.

3. Big data is enabling quality to be quantified. Binder pointed to the leadership of the National Quality Forum (NQF) and others in showing “we can defensibly measure the quality side of the value equation.”

Binder warns that arguments made in the name of clinicians to denounce specific quality measures can backfire. In particular, she pointed to a study published in the BMJ that concluded clinicians have little impact on the “standardized mortality ratio,” therefore they should not be held accountable for it.

“Here’s the damaging assumption in the study: The only way physicians or nurses improve patient survival is by avoiding killer mistakes. Surely clinical skill impacts mortality more than that,” Binder stated in her Modern Healthcare editorial.

Similarly, Binder pointed to a study published in the Journal of the American Medical Association (JAMA) that also minimized the impact of clinicians. The study compared how United States hospitals scored on CMS composite safety measures versus alternative measures the researchers invented based on process quality composites. She summarized the findings as stating, “Some hospitals excel on the invented quality composites but fail on the CMS safety composite. Illogically, the researchers conclude that the CMS safety composite is flawed. One might just as well conclude that the researchers’ composites are flawed.”

“Ultimately, this paints a dismal portrait of individual clinicians. … If you excel on some but not all measures, the measures are wrong and you don’t excel at anything,” she stated.

Leapfrog Group CEO Leah Binder is urging healthcare professionals to embrace the move toward value-based reimbursement and rethink their opposition to quality measures that reward high-quality patient care. “Clinicians have a choice: Seize the momentum of the value movement to finally get rewarded for excellence, or recite tired political talking points that minimize your life’s work,” Binder says. (Photo copyright: Aaron Eckels/Crain’s Detroit Business.)

Leapfrog Group CEO Leah Binder is urging healthcare professionals to embrace the move toward value-based reimbursement and rethink their opposition to quality measures that reward high-quality patient care. “Clinicians have a choice: Seize the momentum of the value movement to finally get rewarded for excellence, or recite tired political talking points that minimize your life’s work,” Binder says. (Photo copyright: Aaron Eckels/Crain’s Detroit Business.)

Leapfrog Group Advocates Transparency for Both Insurers and Patients

The Leapfrog Group was formed in 2000, a year after the Institute of Medicine’s (IOM’s) landmark report on medical errors, “To Err Is Human: Building a Safer Health System,” in which the IOM estimated that preventable medical errors caused 44,000 to 98,000 deaths annually, with an associated cost of $17 billion to $29 billion.

The watchdog organization operates out of Washington, D.C. and is made up of more than 170 of the nation’s largest purchasers of healthcare, including:



Lockheed Martin;

Marriot International;

University of Michigan; and

• the Florida Healthcare Coalition.

Through its annual hospital surveys and research, the non-profit urges insurers and patients to use transparency to improve the safety and quality of the healthcare system.

The Leapfrog Group’s movement for transparency has grown to include more than 1,700 hospitals that participate in its annual survey on safety, quality, and resource use. In 2015, a record 1,750 hospitals submitted a survey, representing 46% of hospitals nationwide. It also has focused attention on reducing early elective deliveries, launched a pay-for-performance program, and designed a Hospital Safety Score to help consumers to make better healthcare decision.

Providers Should Seek Transparency

While negotiations about quality measures have reached a fever pitch, Binder would like to see providers insist on transparency and accountability for their patients, a step she says would validate clinicians’ work and expertise.

“While thoughtful critiques of measures are important, politically-motivated denial of measures is destructive in unintended ways,” Binder stated in her editorial for Modern Healthcare. “It often follows the unfortunate pattern of these studies in assuming that providers perform at essentially the same level of quality and/or their actions can’t be linked to patient survival or healing,” she observed.

“If all physicians and nurses believed their work had such modest impact, the burnout problem might be even worse,” continued Binder. “People who choose a career in healthcare tend to be bright, competitive and caring, and they won’t last long if they believe their talents make virtually no difference.”

As noted above, since the Leapfrog Group represents many of the major purchasers of healthcare, Binder’s recent comments should grab the attention of pathologists and clinical laboratory executives. They would do well to anticipate continued calls for more quality and more measurement of quality in healthcare as the movement toward value-based reimbursement marches on. Contributing value to hospitals, physicians, and payers is quickly becoming the new paradigm for clinical laboratories and pathology groups.

—Andrea Downing Peck

Related Information:

Clinicians Must Push Back Against Critics Challenging the Role of Quality Measures

Standardized Mortality Ratios Should Not Be Used to Benchmark Hospitals, Study Concludes

Leapfrog Group Fact Sheet

Concerns About Using the Patient Safety Indicator-90 Composite in Pay-for-Performance Programs

To Err Is Human: Building a Better Health System

Two Lab Leaders Present Different Ways to Help Physicians Get Greater Value from Clinical Pathology Laboratory Testing

In response to healthcare’s transformation, a pathologist and a lab CEO describe two powerful ways that medical laboratories can collaborate with physicians, patients, health systems, and health insurers to deliver more value

DATELINE: Phoenix, Arizona—It may be appropriate that, with the pace of change heating up in both healthcare and the clinical laboratory industry, it was here in the hot Sonoran Desert that more than 500 medical laboratory professionals gathered last week for the annual Sunquest User Group Conference (SUG) hosted by Sunquest Information Systems. (more…)

UCSF Study Puts Spotlight on the High Prices of Medical Laboratory Tests Charged by California Hospitals

Researchers at the University of California San Francisco revealed that the cost for a simple cholesterol test ranged from as little as $10 to as much as $10,169!

Clinical laboratories owned by hospitals and health systems should take note of a public study of hospital laboratory test prices that was conducted by researchers at the University of California at San Francisco (UCSF). It was published this summer and showed a remarkable range of prices for medical laboratory tests charged by California hospitals.

How about a charge of $10,169 for a routine blood cholesterol test? This was one finding a study discussed in the August 2014 issue of the British Medical Journal Open blog. The study was led by Renee Hsia, M.D.. She is an associate professor of Emergency Medicine and Health Policy at the UCSF Medical School. Hsia and her colleagues compared charges for 10 common clinical laboratory tests that were reported in 2011 by all non-federal California hospitals. (more…)

C. diff-sniffing Beagle Dog Could Lead to Better Infection Control Outcomes in Hospitals and Nursing Homes

In the future, pathologists and clinical laboratory administrators may need to plan for a canine addition to their traditional laboratory staff

See Cliff sniff C. diff! No, that’s not a line from a new reading primer. In fact, it refers to one hospital’s innovation for early detection of Clostridium difficile (C. diff): a two-year-old beagle named Cliff. Cliff the Beagle is faster at detecting certain infections than the standard clinical laboratory tests used daily in hospitals throughout the world.

Researchers from Vrije University Medical Center (VUMC) in Amsterdam successfully used the trained beagle to detect the smell of C. difficile in hospitals. The researchers believe trained canine disease detectives like Cliff could be a cheap and effective way to conduct routine C. diff screening in hospitals. (more…)