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World Economic Forum Publishes Updated List of 12 Breakthroughs in Fight against Cancer That Includes Innovative Clinical Laboratory Test (Part 2)

Nov 20, 2024 | International Laboratory News, Laboratory Pathology, Laboratory Resources, Laboratory Testing, Molecular Diagnostics, Genetic Testing, Whole Gene Sequencing, Precision Medicine

These advances in the battle against cancer could lead to new clinical laboratory screening tests and other diagnostics for early detection of the disease

As Dark Daily reported in part one of this story, the World Economic Forum (WEF) has identified 12 new breakthroughs in the fight against cancer that will be of interest to pathologists and clinical laboratory managers.

As we noted in part one, the WEF originally announced these breakthroughs in an article first published in May 2022 and then updated in October 2024. According to the WEF, the World Health Organization (WHO) identified cancer as a “leading cause of death globally” that “kills around 10 million people a year.”

The WEF is a non-profit organization base in Switzerland that, according to its website, “engages political, business, academic, civil society and other leaders of society to shape global, regional and industry agendas.”

Monday’s ebrief focused on four advances identified by WEF that should be of particular interest to clinical laboratory leaders. Here are the others.

Personalized Cancer Vaccines in England

The National Health Service (NHS) in England, in collaboration with the German pharmaceutical company BioNTech, has launched a program to facilitate development of personalized cancer vaccines. The NHS Cancer Vaccine Launch Pad will seek to match cancer patients with clinical trials for the vaccines. The Launch Pad will be based on messenger ribonucleic acid (mRNA) technology, which is the same technology used in many COVID-19 vaccines.

The BBC reported that these cancer vaccines are treatments, not a form of prevention. BioNTech receives a sample of a patient’s tumor and then formulates a vaccine that exposes the cancer cells to the patient’s immune system. Each vaccine is tailored for the specific mutations in the patient’s tumor.

“I think this is a new era. The science behind this makes sense,” medical oncologist Victoria Kunene, MBChB, MRCP, MSc (above), trial principal investigator from Queen Elizabeth Hospital Birmingham (QEHB) involved in an NHS program to develop personalized cancer vaccines, told the BBC. “My hope is this will become the standard of care. It makes sense that we can have something that can help patients reduce their risk of cancer recurrence.” These clinical trials could lead to new clinical laboratory screening tests for cancer vaccines. (Photo copyright: Queen Elizabeth Hospital Birmingham.)

Seven-Minute Cancer Treatment Injection

NHS England has also begun treating eligible cancer patients with under-the-skin injections of atezolizumab, an immunotherapy marketed under the brand name Tecentriq, Reuters reported. The drug is usually delivered intravenously, a procedure that can take 30 to 60 minutes. Injecting the drug takes just seven minutes, Reuters noted, saving time for patients and cancer teams.

The drug is designed to stimulate the patient’s immune system to attack cancer cells, including breast, lung, liver, and bladder cancers.

AI Advances in India

One WEF component—the Center for the Fourth Industrial Revolution (C4IR)—aims to harness emerging technologies such as artificial intelligence (AI) and virtual reality. In India, the organization says the Center is seeking to accelerate use of AI-based risk profiling to “help screen for common cancers like breast cancer, leading to early diagnosis.”

Researchers are also exploring the use of AI to “analyze X-rays to identify cancers in places where imaging experts might not be available.”

Using AI to Assess Lung Cancer Risk

Early-stage lung cancer is “notoriously hard to detect,” WEF observed. To help meet this challenge, researchers at Massachusetts Institute of Technology (MIT) developed an AI model known as Sybil that analyzes low-dose computed tomography scans to predict a patient’s risk of getting the disease within the next six years. It does so without a radiologist’s intervention, according to a press release.

The researchers tested the system on scans obtained from the National Lung Cancer Screening Trial, Mass General Hospital (MGH), and Chang Gung Memorial Hospital. Sybil achieved C-index scores ranging from 0.75 to 0.81, they reported. “Models achieving a C-index score over 0.7 are considered good and over 0.8 is considered strong,” the press release notes.

The researchers published their findings in the Journal of Clinical Oncology.

Using Genomics to Identify Cancer-Causing Mutations

In what has been described as the “largest study of whole genome sequencing data,” researchers at the University of Cambridge in the UK announced they have discovered a “treasure trove” of information about possible causes of cancer.

Using data from England’s 100,000 Genomes Project, the researchers analyzed the whole genome sequences of 12,000 NHS cancer patients.

This allowed them “to detect patterns in the DNA of cancer, known as ‘mutational signatures,’ that provide clues about whether a patient has had a past exposure to environmental causes of cancer such as smoking or UV light, or has internal, cellular malfunctions,” according to a press release.

The researchers also identified 58 new mutational signatures, “suggesting that there are additional causes of cancer that we don’t yet fully understand,” the press release states.

The study appeared in April 2022 in the journal Science.

Validation of CAR-T-Cell Therapy

CAR-T-cell therapy “involves removing and genetically altering immune cells, called T cells, from cancer patients,” WEF explained. “The altered cells then produce proteins called chimeric antigen receptors (CARs), which can recognize and destroy cancer cells.”

The therapy appeared to receive validation in 2022 when researchers at the University of Pennsylvania published an article in the journal Nature noting that two early recipients of the treatment were still in remission after 12 years.

However, the US Food and Drug Administration (FDA) announced in 2023 that it was investigating reports of T-cell malignancies, including lymphoma, in patients who had received the treatment.

WEF observed that “the jury is still out as to whether the therapy is to blame but, as a precaution, the drug packaging now carries a warning.”

Breast Cancer Drug Repurposed for Prevention

England’s NHS announced in 2023 that anastrozole, a breast cancer drug, will be available to post-menopausal women to help reduce their risk of developing the disease.

“Around 289,000 women at moderate or high risk of breast cancer could be eligible for the drug, and while not all will choose to take it, it is estimated that if 25% do, around 2,000 cases of breast cancer could potentially be prevented in England, while saving the NHS around £15 million in treatment costs,” the NHS stated.

The tablet, which is off patent, has been used for many years to treat breast cancer, the NHS added. Anastrozole blocks the body’s production of the enzyme aromatase, reducing levels of the hormone estrogen.

Big Advance in Treating Cervical Cancer

In October 2024, researchers announced results from a large clinical trial demonstrating that a new approach to treating cervical cancer—one that uses currently available therapies—can reduce the risk of death by 40% and the risk of relapsing by 36%.

Patients are commonly treated with a combination of chemotherapy and radiotherapy called chemoradiotherapy (CRT), according to Cancer Research UK. But outcomes are improved dramatically by administering six weeks of induction therapy prior to CRT, the researchers reported.

“This is the biggest improvement in outcome in this disease in over 20 years,” said Mary McCormack, PhD, clinical oncologist at the University College London and lead investigator in the trial.

The scientists published their findings in The Lancet.

Pathologists and clinical lab managers will want to keep track of these 12 breakthrough advancements in the diagnosis and treatment of cancer highlighted by the WEF. They will likely lead to new screening tests for the disease and could save many lives.

—Stephen Beale

Related Information:

Thousands of Cancer Patients to Trial Personalized Vaccines

England to Rollout World-First Seven-Minute Cancer Treatment Jab

MIT Researchers Develop an AI Model That Can Detect Future Lung Cancer Risk

Largest Study of Whole Genome Sequencing Data Reveals New Clues to Causes of Cancer

Tens of Thousands of Women Set to Benefit from ‘Repurposed’ NHS Drug to Prevent Breast Cancer

Cervical Cancer Treatment Breakthrough Cuts Risk of Death By 40%

Despite the Coronavirus Pandemic, Medicare Officials Continue Push for Price Transparency by Pressuring Hospitals to Disclose Rates Negotiated with Private Payers

Aug 7, 2020 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology

Clinical laboratories are advised to continue developing methods for making prices for procedures available to the general public

Even as an effective treatment for COVID-19 continues to elude federal healthcare agencies, Medicare officials are pressing ahead with efforts to bring about transparency in hospital healthcare pricing, including clinical laboratory procedures and prescription drugs costs.

In FY 2021 Proposed Rule CMS-1735-P, titled, “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals,” the Centers for Medicare and Medicaid Services (CMS) proposes to “revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2021 and to implement certain recent legislation.”

A CMS news release noted, “The proposed rule would update Medicare payment policies for hospitals paid under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) for fiscal year 2021.”

The proposed rule suggests a 1.6% increase (about $2 billion) in reimbursement for hospital inpatient services for 2021, but also eludes to the possibility of payer negotiated rates being used to determine future payment to hospitals.

In its analysis of the proposed rule, Modern Healthcare noted that CMS is “continuing its price transparency push, to the chagrin of some providers.”

However, the provisions in the proposed rule do, according to the CMS news release, advance several presidential executive orders, including:

Promoting Healthcare Choice and Competition Across the US (October 12, 2017),
Improving Price and Quality Transparency in American Healthcare to Put Patients First (June 24, 2019), and
Protecting and Improving Medicare for Our Nation’s Seniors (October 3, 2019.)

Controversial Use of Payer Data for Future Medicare Rates

This latest CMS proposed rule (comments period ended July 10) moves forward “controversial price transparency” and has a new element of possible leverage of reported information for future Medicare payment rates, Healthcare Dive reported.

The 1,602-page proposed rule (CMS-1735-P) calls for these requirements in hospital Medicare cost reports:

Median payer-specific negotiated inpatient services;
Inclusion of rates for Medicare Advantage plans and other third party plans;
Organization of information by Medicare severity-diagnosis related group (MS-DRG) in Medicare cost reports.

“In addition, the agency is requesting information regarding the potential use of these data to set relative Medicare payment rates for hospital procedures,” the CMS news release states.

Thus, under the proposed rule, the nation’s 3,200 acute care hospitals and 360 long-term care hospitals would need to start reporting requested data for discharges effective Oct. 1, 2020, a CMS fact sheet explained.

In the news release following the release of the proposed rule, CMS Administrator Seema Verma had a positive spin. “Today’s payment rate announcement focuses on what matters most to help hospitals conduct their business and receive stable and consistent payment.”

However, the American Hospital Association (AHA) articulated a different view, even calling the requirement for hospitals to report private terms “unlawful.”

AHA Executive Vice President Tom Nickels at a podium — **“We are very disappointed that CMS continues down the unlawful path of requiring hospitals to disclose privately negotiated contract terms,” AHA Executive Vice President** **Tom Nickels** **(above) said in** **a statement**, adding, “The disclosure of privately negotiated rates will not further CMS’ goal of paying market rates that reflect the cost of delivering care. These rates take into account any number of unique circumstances between a private payer and a hospital and simply are not relevant for fixing **Fee-for-Service** **Medicare reimbursement.” (Photo copyright: American Hospital Association.)**

AHA and other organizations attempted to block a price transparency final rule last year in a lawsuit filed against the U.S. Department of Health and Human Services (HHS), which oversees CMS, Dark Daily reported.

During in-court testimony, provider representatives declared that revealing rates they negotiate with payers violates First Amendment rights, Becker’s Hospital Review reported.

Officials for the federal government pushed back telling the federal judge that they can indeed require hospitals to publish negotiated rates. Hospital chargemasters, they added, don’t tell the full story, since consumers don’t pay those rates, Modern Healthcare reported.

2020 Final Rule Affected Clinical Laboratories

In a recent e-briefing on Final Rule CMS-1717-F2 on hospital outpatient price transparency, titled, “Health Insurers and Hospital Groups Argue Price Transparency Rules on Hospitals, Clinical Laboratories, and Other Providers Will Add Costs and ‘Confuse’ Consumers,” May 29, 2020, Dark Daily reported that effective January 1, 2021, hospitals are required to disclose outpatient prices for common lab tests, such as basic metabolic panel, PSA (prostate-specific antigen), and complete blood count (CBC), and 10 other clinical laboratory tests.

In addition to the increase in inpatient payments and price transparency next steps, the recent CMS proposed rule also includes a new hospital payment category for chimeric antigen receptor (CAR) T-cell therapy. The technique uses a patient’s own genetically-modified immune cells to treat some cancers, as an alternative to chemotherapy and other treatment covered by IPPS, CMS said in the news release.

The agency also expressed intent to remove payment barriers to new antimicrobials approved by the FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway). “The LPAD pathway encourages the development of safe and effective drug products that address unmet needs of patients with serious bacterial and fungal infections,” the CMS fact sheet states.

Clinical laboratories are gateways to healthcare. For hospital lab leaders, the notion of making tests prices easily accessible to patients and consumers will soon no longer be a nice idea—but a legal requirement.

Therefore, clinical laboratory leaders are advised to stay abreast of price transparency regulations and continue to prepare for sharing test prices and information with patients and the general public in ways that fulfill federal requirements.

—Donna Marie Pocius

Related Information:

CMS Proposed Rule CMS-1735-P

CMS Final Rule CMS-1717-F2

CMS Aims to Boost Inpatient Payments; Adds Pressure for Price Transparency

CMS Builds on Commitment to Transform Healthcare Through Competition and Innovation

Presidential Executive Order Promoting Healthcare Choice and Competition Across the United States

Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First

Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors

Fact Sheet: FY 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS)

Hospitals Balk as CMS Doubles Down on Price Transparency

AHA Statement on FY 2021 Proposed IPPS Rule