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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?

‘Low-Value’ Medical Lab Tests and Other Overused Medical Procedures Led to $282-Million in ‘Wasted’ Healthcare Spending in Washington State in One Year, Washington Health Alliance Reports

Just eleven common tests and procedures blamed for 93% of low-value services and 89% of wasted spending

Overuse of medical laboratory tests and diagnostic procedures has been a long-standing issue among pathologists and other healthcare providers. Now a Washington State healthcare watchdog organization has put a $282-million price tag on the cost of what it calls “wasteful” spending for “low-value” clinical laboratory tests and other procedures in a single year.

A study by the nonprofit Washington Health Alliance (WHA) examined insurance claims between July 2015 and June 2016 from 1.3 million patients who received one of 47 procedures or tests that had been previously labeled by the US Preventive Services Task Force and Choosing Wisely campaign as overused.

Many pathologists and clinical laboratory managers are familiar with the “Choosing Wisely” initiative. This is a collaboration involving most medical specialty associations. These associations are highlighting a list of medical lab tests and other diagnostic procedures that are ordered inappropriately and with greatest frequency. Thus, the WHA study—involving 1.3 million patients—provides more evidence and credibility in support of the “Choosing Wisely” campaign.

In its study, the WHA determined that, over this 12-month period:

  • More than 45% of the healthcare services examined were determined to be of low value because they have been shown to provide little benefit in certain clinical scenarios;
  • 622,341 (47.9%) patients underwent a low-value test or procedure they didn’t need;
  • 36% of spending went to low-value services, resulting in an estimated $282 million in wasteful spending; and,
  • Eleven common tests, procedures, and treatments—such as: preoperative tests, laboratory studies prior to surgery, and too frequent cancer screenings—account for 93% of low-value services and 89% of the estimated wasted spending.

The WHA found that problematic procedures and tests aren’t necessarily “big-ticket” services but collectively result in unnecessary costs.

“Many of the services are individually low cost, and, therefore, a doctor or patient may not consider it problematic,” Susie Dade, author of the WHA report and Deputy Director at the Washington Health Alliance, told The News Tribune.

“In the alliance’s analysis, we found that about 80% of the low-value services examined for this report are low cost (meaning less than about $500). However, we all pay the price with increased premiums and healthcare costs,” she noted. Precision medicine approaches to personalized healthcare reduces these costs and improves outcomes.

Opportunity for Education/Improvement

The report, “First, Do No Harm: Calculating Health Care Waste in Washington State,” used the new MedInsight Health Waste Calculator from actuarial consulting firm Milliman, to produce the analysis.

The report found the following 11 tests and procedures (listed in descending order based on volume) were the most overused low-value services:

  1. Too frequent cervical cancer screening in women;
  2. Preoperative baseline laboratory studies before low-risk surgery;
  3. Unnecessary imaging for eye disease;
  4. Annual EKGs or cardiac screening in low-risk, asymptomatic individuals;
  5. Prescribing antibiotics for acute upper respiratory and ear infections;
  6. PSA (prostate specific antigen) screening;
  7. Population-based screening for 25(OH)-D deficiency;
  8. Imaging for uncomplicated low back pain in the first six weeks;
  9. Preoperative EKG, chest x-ray, and pulmonary function testing prior to low-risk surgery;
  10. Cardiac stress testing; and,
  11. Imaging for uncomplicated headache.


Nancy Giunto (above left), Executive Director of the Washington Health Alliance, called her state’s results “stunning” and noted the WHA report provides “a clear opportunity to educate patients and engage healthcare stakeholders on areas of improvement.” Such an individualized approach to healthcare is at the heart of precision medicine. She’s shown above with previous WHA Executive Directors Mary McWilliams and Margaret Stanley. (Photo copyright: Washington Health Alliance.)

US Healthcare Culture Partly to Blame

“The list of 11 is a starting point for us,” Dade told Modern Healthcare. “I think they will become a rallying point for coming up with specific education and specific interventions.”

Dade suggests the healthcare culture in the US plays a role in the epidemic of unnecessary testing.

“In some cases patients ask for or agree to things because they don’t realize the potential for harm, be it physical, emotional, or financial, that can happen with unnecessary tests, procedures or medications,” Dade told The News Tribune. “In other cases, tests are ordered by providers, with little input or even awareness of the patient.

“In a ‘more is better’ culture in healthcare, there is a belief that it’s better to have additional tests because it’s better to be safe than sorry. However, this doesn’t account for the potential for different kinds of harm.”

  1. Gilbert Welch, MD, MPH, a professor at The Dartmouth Institute, told National Public Radio (NPR) part of the blame should be placed on a healthcare system that often incentivizes healthcare providers to do more than what is medically necessary.

“The medical system is still dominated by a payment system that pays providers for doing tests and procedures. Incentives matter. As long as people are paid more to do more they will tend to do too much,” Welch said.

Value-based Care the Solution to Overuse

The Washington Healthcare Alliance believes one key to eliminating overuse can be found in the transition from fee-for-service healthcare to value-based reimbursement models. The WHA report states: “We need to keep our collective ‘foot on the gas’ to transition from paying for volume to paying for value in healthcare.” In addition, the alliance suggests value-based provider contacts should include measures of overuse, and not just measures of access and underuse.

The report also suggests consumers take a more active role in their healthcare decision making by asking these five questions before having a medical test or procedure:

  1. Do I really need this test or procedure?
  2. What are the risks and side effects?
  3. Are there simpler, safer options?
  4. What happens if I don’t do anything?
  5. How much does it cost, and will my insurance pay for it?

Clinical laboratories and anatomic pathology groups can help put the brakes on unnecessary laboratory testing and procedures by guiding physicians toward evidence-based medical care and a renewed focus on “do no harm.”

“What we strive for is substantially reducing the risk of preventable harm,” the report states. “Reducing unnecessary overuse of healthcare services is one important way to do this. The result of the ‘more is always better’ culture present in today’s healthcare delivery seems to be ‘first, do something.’ It is time to get back to ‘first, do no harm.”

—Andrea Downing Peck

Related Information:

First, Do No Harm: Calculating Health Care Waste in Washington State

New Study Finds Hundreds of Thousands of Washington Patients Receive Unnecessary Tests, Procedures and Treatments

Washington Residents’ Tab for Unneeded Care in a Year: $280 million-plus

Unnecessary Medical Care: More Common than You Might Imagine

You’re Getting Nickel and Dimed for Low-Value Medical Tests in Washington, Report Says

Why Healthcare Experts Critical of Direct Access Testing Advise Clinical Laboratories to Take Precautions

Test ordering and results interpretation can confuse the public says Dartmouth Institute, which is why some clinical laboratories limit the types of lab tests that people can request

Giving consumers direct access to medical laboratory testing continues to be a subject of some controversy. One factor in this debate is Theranos, which brought much attention to direct access testing, followed by extensive news coverage in recent months of its problems with reporting accurate clinical laboratory test results.

Concerns about allowing consumers to have direct access to lab testing were the subject of a recent National Public Radio (NPR) Shots Health News story. Several medical experts were interviewed and described why they had concerns about direct access testing (DAT).

One such expert is H. Gilbert Welch, MD, MPH, Professor of Medicine, Community and Family Medicine at The Dartmouth Institute (Dartmouth). According to Welch, DAT could contribute to over-diagnosis and give people an inaccurate impression of what good health actually means. (more…)