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IBM’s Watson Not Living Up to Hype, Wall Street Journal and Other Media Report; ‘Dr. Watson’ Has Yet to Show It Can Improve Patient Outcomes or Accurately Diagnose Cancer

Wall Street Journal reports IBM losing Watson-for-Oncology partners and clients, but scientists remain confident artificial intelligence will revolutionize diagnosis and treatment of disease

What happens when a healthcare revolution is overhyped? Results fall short of expectations. That’s the diagnosis from the Wall Street Journal (WSJ) and other media outlets five years after IBM marketed its Watson supercomputer as having the potential to “revolutionize” cancer diagnosis and treatment.

The idea that artificial intelligence (AI) could be used to diagnose cancer and identify appropriate therapies certainly carried with it implications for clinical laboratories and anatomic pathologists, which Dark Daily reported as far back as 2012. It also promised to spark rapid growth in precision medicine. For now, though, that momentum may be stalled.

“Watson can read all of the healthcare texts in the world in seconds,” John E. Kelly III, PhD, IBM Senior Vice President, Cognitive Solutions and IBM Research, told Wired in 2011. “And that’s our first priority, creating a ‘Dr. Watson,’ if you will.”

However, despite the marketing pitch, the WSJ investigation published in August claims IBM has fallen far short of that goal during the past seven years. The article states, “More than a dozen IBM partners and clients have halted or shrunk Watson’s oncology-related projects. Watson cancer applications have had limited impact on patients, according to dozens of interviews with medical centers, companies and doctors who have used it, as well as documents reviewed by the Wall Street Journal.”

Anatomic pathologists—who use tumor biopsies to diagnose cancer—have regularly wondered if IBM’s Watson would actually help physicians do a better job in the diagnosis, treatment, and monitoring of cancer patients. The findings of the Wall Street Journal show that Watson has yet to make much of a positive impact when used in support of cancer care.

The WSJ claims Watson often “didn’t add much value” or “wasn’t accurate.” This lackluster assessment is blamed on Watson’s inability to keep pace with fast-evolving treatment guidelines, as well as its inability to accurately evaluate reoccurring or rare cancers. Despite the more than $15 billion IBM has spent on Watson, the WSJ reports there is no published research showing Watson improving patient outcomes.

Lukas Wartman, MD, Assistant Professor, McDonnell Genome Institute at the Washington University School of Medicine in St. Louis, told the WSJ he rarely uses the Watson system, despite having complimentary access. IBM typically charges $200 to $1,000 per patient, plus consulting fees in some cases, for Watson-for-Oncology, the WSJ reported.

“The discomfort that I have—and that others have had with using it—has been the sense that you never know how much faith you can put in those results,” Wartman said.

Rudimentary Not Revolutionary Intelligence, STAT Notes

IBM’s Watson made headlines in 2011 when it won a head-to-head competition against two champions on the game show “Jeopardy.” Soon after, IBM announced it would make Watson available for medical applications, giving rise to the idea of “Dr. Watson.”

In a 2017 investigation, however, published on STAT, Watson is described as in its “toddler stage,” falling far short of IBM’s depiction of Watson as a “digital prodigy.”

“Perhaps the most stunning overreach is in [IBM’s] claim that Watson-for-Oncology, through artificial intelligence, can sift through reams of data to generate new insights and identify, as an IBM sales rep put it, ‘even new approaches’ to cancer care,” the STAT article notes. “STAT found that the system doesn’t create new knowledge and is artificially intelligent only in the most rudimentary sense of the term.”

STAT reported it had taken six years for data engineers and doctors to train Watson in just seven types of cancers and keep the system updated with the latest knowledge.

“It’s been a struggle to update, I’ll be honest,” Mark Kris, MD, oncologist at Memorial Sloan Kettering Cancer Center in New York and lead Watson trainer, told STAT. “Changing the system of cognitive computing doesn’t turn on a dime like that. You have to put in the literature, you have to put in the cases.” (Photo copyright: Physician Education Resource.)

Watson Recommended Unsafe and Incorrect Treatments, STAT Reported

In July 2018, STAT reported that internal documents from IBM revealed Watson had recommended “unsafe and incorrect” cancer treatments.

David Howard, PhD, Professor, Health Policy and Management, Rollins School of Public Health at Emory University, blames Watson’s failure in part to the dearth of high-quality published research available for the supercomputer to analyze.

“IBM spun a story about how Watson could improve cancer treatment that was superficially plausible—there are thousands of research papers published every year and no doctor can read them all,” Howard told HealthNewsReview.org. “However, the problem is not that there is too much information, but rather there is too little. Only a handful of published articles are high-quality, randomized trials. In many cases, oncologists have to choose between drugs that have never been directly compared in a randomized trial.”

Howard argues the news media needs to do a better job vetting stories touting healthcare breakthroughs.

“Reporters are often susceptible to PR hype about the potential of new technology—from Watson to ‘wearables’—to improve outcomes,” Howard said. “A lot of stories would turn out differently if they asked a simple question: ‘Where is the evidence?’”

Peter Greulich, a retired IBM manager who has written extensively on IBM’s corporate challenges, told STAT that IBM would need to invest more money and people in the Watson project to make it successful—an unlikely possibility in a time of shrinking revenues at the corporate giant.

“IBM ought to quit trying to cure cancer,” he said. “They turned the marketing engine loose without controlling how to build and construct a product.”

AI Could Still Revolutionize Precision Medicine

Despite the recent negative headlines about Watson, AI continues to offer the promise of one day changing how pathologists and physicians work together to diagnose and treat disease. Isaac Kohane, MD, PhD, Chairman of the Biomedical Informatics Program at Harvard Medical School, told Bloomberg that IBM may have oversold Watson, but he predicts AI one day will “revolutionize medicine.”

“It’s anybody’s guess who is going to be the first to the market leader in this space,” he said. “Artificial intelligence and big data are coming to doctors’ offices and hospitals. But it won’t necessarily look like the ads on TV.”

How AI and precision medicine plays out for clinical laboratories and anatomic pathologists is uncertain. Clearly, though, healthcare is on a path toward increased involvement of computerized decision-making applications in the diagnostic process. Regardless of early setbacks, that trend is unlikely to slow. Laboratory managers and pathology stakeholders would be wise to keep apprised of these developments.

—Andrea Downing Peck

Related Information:

IBM’s Watson Supercomputer Recommended ‘Unsafe and Incorrect’ Cancer Treatments, Internal Documents Show

IBM Pitched its Watson Supercomputer as a Revolution in Cancer Care. It’s Nowhere Close

IBM’s Watson Wins Jeopardy! Next Up: Fixing Health Care

IBM’s Watson Supercomputer Wins Practice Jeopardy Round

Memorial Sloan-Kettering Cancer Center, IBM to Collaborate in Applying Watson Technology to Help Oncologists

IBM Has a Watson Dilemma

MD Anderson Cancer Center’s IBM Watson Project Fails, and So Did the Journalism Related to It

What Went Wrong with IBM’s Watson?

IBM’s Watson Failed Against Cancer but AI Still Has Promise

Will IBM’s ‘Watson on Oncology’ Give Oncologists and Pathologists a Useful Tool for Diagnosing and Treating Various Cancer

Pathologists Take Note: IBM’s Watson to Attack Cancer with Help of WellPoint and Cedars-Sinai

Kaiser Health News Labels Routine Clinical Laboratory Testing and Other Screening of Elderly Patients an ‘Epidemic’ in US

Some experts in medical community question value of health screenings of older patients with shortened life expectancies, though many aging adults are skeptical of calls to skip tests

What does it mean when a credible health organization makes the assertion that there is an “epidemic” of clinical laboratory testing being ordered on the nation’s elderly? Clinical laboratory leaders and anatomic pathologists know that lab tests are a critical part of screening patients.

Health screenings, particularly those for chronic diseases, such as cancer, can save lives by detecting diseases in their early stages. However, as consumers become more engaged with the quality of their care, one trend is for healthcare policymakers to point out that many medical procedures and care protocols may not bring benefit—and may, instead, bring harm.

No less an authority than Kaiser Health News (KHN) also is questioning what it calls an “epidemic” of testing in geriatric patients. Since medical laboratory tests are part of many screening programs, a rethinking of what tests are necessary in older patients would likely impact clinical laboratories and pathology groups going forward.

Treatment Overkill or Necessary Clinical Laboratory Tests?

“In patients well into their 80s, with other chronic conditions, it’s highly unlikely that they will receive any benefit from screening, and [it is] more likely that the harms will outweigh the benefits,” Cary Gross, MD, Professor of Medicine and Director of the National Clinician Scholars Program at the Yale School of Medicine, told KHN as part of an investigative series called “Treatment Overkill.”

That opinion is supported by a 2014 study published in the Journal of the American Medical Association (JAMA) Internal Medicine. The researchers concluded, “A substantial proportion of the US population with limited life expectancy received prostate, breast, cervical, and colorectal cancer screening that is unlikely to provide net benefit. These results raise concerns about over screening in these individuals, which not only increases healthcare expenditure but can lead to patient harm.”

Yet, seniors and their family members often request health screenings for themselves or their elderly parents, even those with dementia, if they perceive doing so will improve their quality of life, KHN noted.

Cary Gross, MD

Cary Gross, MD, Professor of Medicine and Director of the National Clinician Scholars Program at Yale University, told Kaiser Health News patients “well into their 80s, with other health conditions” are unlikely candidates for the many routine health screening tests administered to elderly patients. Were this to become a trend, medical laboratories could see a drop in physician-ordered screening tests. (Photo copyright: Yale University.)

Meanwhile, an earlier study in JAMA Internal Medicine found older adults perceived screening tests as “morally obligatory” and were skeptical of stopping routine screenings.

In its series, KHN noted two studies that outlined the frequency of screening tests in seniors with limited life expectancies due to dementia or other diseases:

  1. According to the American Journal of Public Health, nearly one in five women with severe cognitive impairment are still getting regular mammograms;
  2. Likewise, 55% of older men with a high risk of death over the next decade still receive PSA tests for prostate cancer, the 2014 JAMA Internal Medicine study found.

“Screening tests are often done in elderly patients as a knee-jerk reaction,” Damon Raskin, MD, a board-certified internist in Pacific Palisades, Calif., who also serves as Medical Director for two skilled nursing facilities, told AgingCare.com.

Correct Age or Correct Test?

While a movement may be afoot to reduce screening tests in older patients, a one-size-fits-all answer to who should continue to be tested may not be possible.

“You can have an 80-year-old who’s really like a 60-year-old in terms of [his or her] health,” Raskin noted. “In these instances, screening tests such as mammograms and colonoscopies, can be extremely valuable. However, I’ve seen 55-year-olds who have end-stage Parkinson’s or Alzheimer’s disease. For those individuals, I probably wouldn’t recommend screenings, for quality of life reasons.”

However, for the general population, researchers have emphasized that the focus should not be on whether physicians are ordering “unnecessary” lab tests, but whether they are ordering the “correct” tests.

A 2013 study published in the online journal PLOS ONE analyzed 1.6 million results from 46 of medicine’s 50 most commonly ordered lab tests. Researchers found, on average, the number of unnecessary tests ordered (30%) was offset by an equal number of necessary tests that went unordered.

“It’s not ordering more tests or fewer tests that we should be aiming for. It’s ordering the right tests, however few or many that is,” senior author Ramy Arnaout, MD, Harvard Medical School, Assistant Professor of Pathology and Associate Director of the Clinical Microbiology Laboratories at Beth Israel Deaconess Medical Center in Boston, stated in a news release. “Remember, lab tests are inexpensive. Ordering one more test or one less test isn’t going to ‘bend the curve,’ even if we do it across the board. It’s everything that happens next—the downstream visits, the surgeries, the hospital stays—that matters to patients and to the economy and should matter to us.”

Since the elderly are the fastest growing population in America, and since diagnosing and treating chronic diseases is a multi-billion-dollar industry, it seems unlikely that such a trend to move away from medical laboratory health screenings for the very old will gain much traction. Still, with increasing focus on healthcare costs, the federal government may pressure doctors to do just that.

—Andrea Downing Peck

Related Information:

Cancer Screening Rates in Individuals with Different Life Expectancies

Doing More Harm Than Good? Epidemic of Screening Burdens Nation’s Older Patients

Large-Scale Analysis Describes Inappropriate Lab Testing Throughout Medicine

Preventive Screening for Seniors: Is that Test Really Necessary?

Impact of Cognitive Impairment on Screening Mammography Use in Older US Women

Cancer Screening Rates in Individuals with Different Life Expectancies

The Landscape of Inappropriate Laboratory Testing

Older Adults and Forgoing Cancer Screening: ‘Think it would be Strange’

Sales of Direct-to-Consumer Clinical Laboratory Genetic Tests Soar, as Members of Congress Debate How Patient Data Should be Handled, Secured, and Kept Private

Direct-to-consumer (DTC) genetic testing has been much in the news of late and clinical laboratories, anatomic pathology groups, and biomedical researchers have a stake in how the controversy plays out.

While healthcare consumers seem enamored with the idea of investigating their genomic ancestry in growing numbers, the question of how the data is collected, secured, and distributed when and to whom, is under increased scrutiny by federal lawmakers, bioethicists, and research scientists.

However, should public demand for DTC testing find support in Congress, some lab companies offering direct-to-consumer genetic tests could find their primary source of revenue curtailed.

DTC Sales Skyrocket as FDA Authorizes Genetic Tests for Certain Chronic Diseases

Dark Daily reported last fall on one company that had its plans to distribute thousands of free genetic tests at a football game suspended due to privacy concerns. (See, “State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?” October 13, 2017.)

Nevertheless, consumer demand for DTC tests continues to rise. In a press release, Ancestry, a family genetic history and consumer genomics company, reported:

  • Record sales of AncestryDNA kits during the 2017 four-day Black Friday to Cyber Monday weekend, selling more than 1.5 million kits; and,
  • The 2017 sales were triple the amount of kits sold during the same period in 2016.

Possibly helping the sale of DTC genetic tests may be the US Food and Drug Administration (FDA) authorization last year of 23andMe’s Personal Genome Service Genetic Health Risk tests for 10 diseases or conditions, including:

Senator Calls for Investigation of DTC Genetic Test Company Use of Patient Data

These are impressive sales. However, medical professionals may wonder how so much genetic data can be kept private by the testing companies. And medical laboratory leaders are not the only ones asking about privacy and the use of genetic test results.

In a November press conference, Senate Minority Leader Chuck Schumer called on the Federal Trade Commission (FTC) to look into genetic testing companies’ privacy and disclosure practices, noted NBC News.

“What those companies can do with all that data—your most sensitive and deepest info, your genetics—is not clear, and in some cases not fair and not right,” stated Schumer.

Congress took action in 2008 by passing the Genetic Information and Nondiscrimination Act (GINA), which bans employers and insurers from making decisions about people based on genetic predispositions to disease.

However, lawmakers also recently introduced House Bill 1313, the Preserving Employee Wellness Programs Act. It reads, in part, “… the collection of information about the manifested disease or disorder of a family member shall not be considered an unlawful acquisition of genetic information with respect to another family as part of a workplace wellness program offered by an employer ….”

“We’re injecting terrible opportunities for discrimination in the workplace,” Robert Green, MD, Professor of Medicine (Genetics) at Harvard Medical School, told Gizmodo.

Robert C. Green, MD, MPH

Robert C. Green, MD, MPH (above), Professor of Medicine, Harvard Medical School; Associate Physician, Brigham and Women’s Hospital; Geneticist, Brigham and Women’s Hospital; and Director, Genomes2People Research Program at Brigham and Women’s Hospital, believes weak genetic privacy laws are inhibiting research and clinical care. “People decline genetic tests because of concerns over privacy and genetic discrimination, especially insurance discrimination,” he told Gizmodo. “This is stymying biomedical research and people’s access to healthcare.” (Photo copyright: Harvard Medical School.)

HIPAA Enables Selling of Anonymized Patient Genetic Data

Peter Pitts, former FDA Associate Commissioner, and President and Co-founder of the Center for Medicine in the Public Interest, a non-profit medical issues research group, blames the release of data by DTC genetic test companies on the Health Insurance Portability and Accountability Act (HIPAA), a law he says makes way for “anonymized” sale of patient data.

“The Portability Act was passed when genetic testing was just a distant dream on the horizon of personalized medicine,” Pitts wrote in a Forbes commentary. “But today that loophole has proven to be a cash cow. 23andMe has sold access to its database to at least 13 outside pharmaceutical firms … AncestryDNA recently announced a lucrative data-sharing partnership with the biotech company Calico.”

For its part, in an online privacy statement, 23andMe noted, “We will use your genetic information or self-reported information and share it with third parties for scientific research purposes only if you sign the appropriate consent document.”

Similarly, Ancestry points out in its posted privacy statement, “We share your genetic information with research partners only when you provide us with your express consent to do so through our informed consent to research.

Consumers Speak Out on Privacy; States Study Laws and Genetic Testing by Research Hospitals

How do consumers feel about the privacy of their genetic test data?  According to a news release, a survey by 23andMe found the following:

  • 80% of Americans are concerned about DNA testing privacy; however,
  • 88% have no awareness or understanding of what testing companies do to protect information; and,
  • 74% of people are, nonetheless, interested in genetic testing.

Meanwhile, as states promulgate various genetic privacy laws, a paper published at SSRN by researchers at the Massachusetts Institute of Technology (MIT) and the University of Virginia (UV) examined how different state laws affect patients’ decisions about having genetic testing performed at various research hospitals.

The MIT/UV study focused on genetic testing by research hospitals as opposed to the DTC genetic testing by private companies. The paper explained that states have one of three types of laws to protect patients’ privacy in genetic testing:

  • “Require the provider to notify the individual about potential privacy risks;
  • “Restrict discriminatory use of genetic data by employers or insurance companies; and,
  • “Limit redisclosure without consent.”

Findings, netted from more than 81,000 respondents, suggest:

  • When genetic data are explained in state laws as patient property, more tests are performed;
  • Conversely, state laws that focus on risk, and ask patients to consent to risk, lead to less people giving the go-ahead for genetic testing.

“We found a positive effect [on the number of tests] was an approach where you gave patients the potential to actually control their own data,” Catherine Tucker, PhD,  Distinguished Professor of Management at MIT and one of the study researchers, told MIT News.

Whether the provider of genetic tests is a private testing company or a research hospital’s clinical laboratory, privacy continues to be a concern, not just to physicians but to federal lawmakers as well. Nevertheless, healthcare consumers and patients who receive comprehensible information about how their genetic data may be used seem to be agreeable to it. At least for now, that is.

—Donna Marie Pocius

Related Information:

AncestryDNA Breaks Holiday Sales Record Black Friday to Cyber Monday

Senator Calls for More Scrutiny of Home DNA Test Industry

The Present and Future Asymmetry of Consumer Genetic Testing

Are Our Terrible Genetic Privacy Laws Hurting Science?

The Privacy Delusions of Genetic Testing

National Survey Shows Strong Interest in DNA Testing

Privacy Protection, Personalized Medicine, and Genetic Testing

How Privacy Policies Affect Genetic Testing

State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?

Targeted Cancer Therapies Bring New Precision Medicine Tools to Anatomic Pathologists and Clinical Laboratories

FDA is streamlining how new diagnostic tests are approved; encourages IVD companies to focus on ‘qualifying biomarkers’ in development of new cancer drugs

It is good news for the anatomic pathology profession that new insights into the human immune system are triggering not only a wave of new therapeutic drugs, but also the need for companion diagnostic tests that help physicians decide when it is appropriate to prescribe immunotherapy drugs.

Rapid advances in precision medicine, and the discovery that a patient’s own immune system can be used to suppress chronic disease, have motivated pharmaceutical companies to pursue new research into creating targeted therapies for cancer patients. These therapies are based on a patient’s physiological condition at the time of diagnosis. This is the very definition of precision medicine and it is changing how oncologists, anatomic pathologists, and medical laboratories diagnose and treat cancer and other chronic diseases.

Since immunotherapy drugs require companion diagnostic tests, in vitro diagnostic (IVD) developers and clinical laboratory and pathology group leaders understand the stake they have in pharma companies devoting more research to developing these types of drugs.

New cancer drugs combined with targeted therapies would directly impact the future of anatomic pathology and medical laboratory testing.

Targeted Therapies Cost Less, Work Better

Targeted therapies focus on the mechanisms driving the cancer, rather than on destroying the cancer itself. They are designed to treat cancers that have specific genetic signatures.

One such example of a targeted therapy is pembrolizumab (brand name: Keytruda), a humanized antibody that targets the programmed cell death 1 (PD-1) receptor. The injection drug was primarily designed to treat melanoma. However, the FDA recently expanded its approval of Keytruda to include treatment of tumors with certain genetic qualities, regardless of the tumor’s location in the body. It was the first time the FDA has expanded an existing approval.

In a Forbes article, David Shaywitz, MD, PhD, noted that pembrolizumab had “an unprecedented type of FDA approval … authorizing its use in a wide range of cancers.” Shaywitz is Chief Medical Officer of DNAnexus in Mountain View, Calif.; Visiting Scientist, Department of Biomedical Informatics at Harvard Medical School; and Adjunct Scholar, American Enterprise Institute.

Cancers with high mutational burdens respond to the therapy because they are more likely to have what Shaywitz calls “recognizable novel antigens called mutation-associated neoantigens, or MANAs.” Such cancers include melanomas, non-small cell lung cancer, some rare forms of colorectal cancers, and others.

Such therapies require genetic sequencing, and because sequencing is becoming faster and less expensive—as is the analysis of the sequencing—the information necessary to develop targeted therapies is becoming more accessible, which is part of what’s motivating pharma research.

Biomarkers and Traditional versus Modern Drug Testing and Development

At the same time pharma is developing new immunotherapies, the FDA is recognizing the benefit of faster approvals. In an FDA Voice blog post, Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER) at the FDA, wrote, “In the past three years alone, [we have] approved more than 25 new drugs that benefit patients with specific genetic characteristics … and we have approved many more new uses—also based on specific genetic characteristics—for drugs already on the market.”

In his Forbes article, Shaywitz notes that pembrolizumab’s development foreshadows a “More general trend in the industry,” where the traditional phases of drug testing and development in oncology are becoming less clear and distinct.

Along with the changes to drug development and approval that precision medicine is bringing about, there are also likely to be changes in how cancer patients are tested. For one thing, biomarkers are critical for precision medicine.

However, pharmaceutical companies have not always favored using biomarkers. According to Shaywitz, “In general, commercial teams tend not to favor biomarkers and seek to avoid them wherever possible.” And that, “All things being equal, a doctor would prefer to prescribe a drug immediately, without waiting for a test to be ordered and the results received and interpreted.”

In July, just weeks after expanding its approval for Keytruda, the FDA approved a Thermo Fisher Scientific test called the Oncomine Dx Target Test. A Wired article describes it as “the first next-generation-sequencing-based test” and notes that it “takes a tiny amount of tumor tissue and reports on alterations to 23 different genes.”

Thermo Fisher’s Oncomine DX Target Test (above) is the first multi-drug next-generation sequencing test approved by the FDA. The test is a companion diagnostic for lung-cancer drugs made by Novartis and Pfizer. (Caption and photo copyright: Thermo Fisher Scientific.)

Unlike pembrolizumab, however, the Oncomine Dx Target Test did not enjoy fast-track approval. As Wired reported, “Getting the FDA’s approval took nearly two years and 220,000 pages of data,” in large part because it was the first test to include multiple genes and multiple drugs. Thus, according to Joydeep Goswami, PhD, President of Clinical Next Generation Sequencing at Thermo Fisher, “That put the technology under extraordinary scrutiny.”

FDA Encouraging Use of Biomarkers in Precision Medicine Therapies

The FDA, however, is taking steps to make that process easier. Woodcock noted in her FDA Voice blog post that the agency is actively encouraging drug developers to “use strategies based on biomarkers.” She added that the FDA currently “works with stakeholders and scientific consortia in qualifying biomarkers that can be used in the development of many drugs.”

Additionally, in a column he penned for Wired, Robert M. Califf, MD, former Commissioner of the FDA, states that the organization has “begun to lay out a flexible roadmap for regulatory approval.” He notes, “Given the complexity of NGS [next-generation-sequencing] technology, test developers need assurance as well, and we’ve tried to reduce uncertainty in the process.”

Regulations that assist IVD developers create viable diagnostics, while ensuring the tests are accurate and valid, will be nearly as important in the age of precision medicine as the therapies themselves.

All of these developmental and regulatory changes will impact the work done by pathologists and medical laboratories. And since precision medicine means finding the right drug for the individual patient, then monitoring its progress, all of the necessary tests will be conducted by clinical laboratories.

Faster approvals for these new drugs and tests will likely mean steep learning curves for pathologists. But if the streamlined regulation process being considered by the FDA works, new immunoassay tests and targeted therapies could mean improved outcomes for cancer patients.

—Dava Stewart

Related Information:

How Precision Medicine, Immunotherapy Are Influencing Clinical Trial Design for Cancer Drugs

Pharma Cooperates to Achieve Precision Medicine

The Startling History Behind Merck’s New Cancer Blockbuster

Two Recent Scientific Advances Underscore an Encouraging Future for Precision Medicine at FDA

Fast, Precise Cancer Care Is Coming to a Hospital Near You

Biomarker Trends Are Auspicious for Pathologists and Clinical Laboratories

Precision Healthcare Milestone Reached as Food and Drug Administration Clears New Multi-Marker Medical Laboratory Test to Detect Antibiotic-Resistant Bacteria

Genetic Tests and Precision Medicine Start to Win Acceptance by Some Payers; Pathologists and Clinical Laboratories Have Opportunity as Advisors

Attention Blood Bankers and Pathologists! New Cloud-Based Technology Platform Provides Hospitals with Real-Time, On-Demand Access to Blood Products at the Best Prices

To match the supply of blood products to demand, a clever entrepreneur has created an award-winning business that may help clinical laboratories better manage the cost of blood products in their hospitals and health systems

There’s something new and exciting in the world of blood banking and medical laboratory medicine. It’s a unique approach to matching the availability of blood products to the demand for those same products and it’s catching the attention of medical laboratory directors and blood bankers in many of the nation’s hospitals.

How did an ice storm and a Super Bowl factor into the development of an innovative and disruptive technology that addresses a persistent gap in the US blood products supply chain? In February 2011, central Texas was hit by fierce weather that not only disrupted flights, snarled traffic, and threatened Super Bowl XLV, it also impacted the local and regional hospitals’ ability to access blood for patients in need. Enter a young entrepreneur who saw a critical problem and understood that the raw materials for a solution already existed. (more…)

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