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

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

Hosted by Robert Michel
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Clinical Laboratory Accuracy and Quality Is under Increased Scrutiny as Precision Medicine Puts Diagnostics in the Spotlight

As the public gains awareness of the role clinical laboratories play in modern healthcare, increased engagement and understanding of the technology underlying many of these advances could create risk for labs without transparent reporting protocols to both patients and the public

In recent years, consumers have continually raised the bar in their expectation of quality when they interact with the healthcare system. Not only do patients expect providers—including clinical laboratories and anatomic pathology groups—to improve regularly over time, but the public has even less tolerance for medical errors of any type. Thus, a recent NPR story is one more warning to the medical laboratory profession that it should be devoting resources and effort to improving quality.

Today’s healthcare consumers and patients are more educated about and involved in the care process than ever before. While the exact science and skills may not interest the general public, the technologies underpinning much of the shift toward personalized medicine (AKA, precision medicine) are the same technologies that created the always-connected, digital lifestyles seen around the world.

With this, comes a level of scrutiny and questioning from the public that clinical laboratories or anatomic pathology groups would not have experienced even just a decade ago.

Mounting Scrutiny of Medical Laboratories and Healthcare Professionals

A recent segment on NPR’sAll Things Considered” highlighted this trend and questioned the quality control standards behind many of the procedures powering current testing. The segment also questioned the impact quality control has on the quality of biobanks used to research and create future technologies and tests.

Pathologist Richard Friedberg, PhD, Medical Director of Baystate Reference Laboratories and former president of the College of American Pathologists, told NPR, “We need to be sure that the stuff [doctors and researchers are] looking at is valid, accurate, reliable, and reproducible … If it’s garbage in, it’s garbage out.”

The story highlights improved standards and guidelines surrounding immunohistochemical (IHC) HER2 tests in the early 2000s. In 2007, The New York Times questioned the reliability of the tests, based on studies presented to the American Society of Clinical Oncology the week prior.

In response, the American Society of Clinical Oncology and the College of American Pathologists released guideline recommendations outlining the exact standards required to reduce assay variation and ensure that data produced is accurate and reproducible. NPR’s coverage claims this is the only test with such strict guidelines.

“I don’t think physicians think this way about their entire medical system,” Carolyn Compton, PhD, CMO of the National Biomarker Development Alliance, CMO of the Complex Adaptive Systems Initiative, and professor of Life Sciences at Arizona State University, told NPR. “I don’t see how we’re going to get precision medicine at the end of the day when everything under the hood is so imprecise.”

Atul-Butte-PhD

Atul Butte, PhD (above), Director of the Institute of Computation Health Sciences at the University of California-San Francisco, presents an alternate side to Compton and Friedberg’s views in the NPR article. “I am not a believer in garbage-in, garbage out at all,” he said. “I know that no one scientist, no one clinician or pathologist is perfect … But, I’d rather take 10 or 100 so-called mediocre data sets and find out what’s in common, then to take one who says they’re perfect at doing this kind of measurement.” (Photo copyright: Santiago Mejia/San Francisco Chronicle.)

 

When data and previous research powers much of the innovation taking place across the modern healthcare landscape, the accuracy of said data would seem critical. Yet, without standards in place, there’s not always safeties by which to verify sample integrity and other critical concerns.

Late last year, Dark Daily reported on a study published in PLOS ONE from Radboud University in the Netherlands questioning the accuracy of more than 30,000 published scientific studies that contained misidentified or contaminated cell lines. Guidelines, such as those created for IHR and FISH HER2 testing, provide standards intended to prevent such issues from occurring or detecting them when they do occur.

Quality versus Quantity: A Gamble Worth Taking?

Apart from challenges with healthcare reform and the regulatory landscape surrounding precision medicine, medical laboratories also must struggle with the challenges of gleaning and maintaining useful, accurate information from an ever-growing trove of data produced by analyzers and assays.

Yet, these mediocre datasets include the results of tests that carried a potentially significant impact on patient lives. In the first two weeks of February alone, both the St. Louis Post-Dispatch and The Telegraph published stories related to erroneous testing related to cancer and the potential impact on the clinical laboratories involved and the patients tested.

Increased coverage shows that the world is watching what goes on in medical laboratories, hospitals, and data centers as healthcare continues to evolve. Clinical laboratories must move forward with this in mind or risk pushback and questioning from the public. Transparency regarding standards, and reporting information to patients surrounding testing or concerns, might effectively address this rising trend.

“We are moving faster and faster and faster as this whole precision medicine train is moving down the track,” Tim Allen, MD, Laboratory Director at the University of Texas Medical Branch Department of Laboratory Services, told NPR. “I suspect standardization of these things is going to become a reality much quicker than I would have expected even a few years ago.”

That quality control issues in anatomic pathology are considered newsworthy by no less than NPR is a sign of increased public attention to the quality of lab testing. The story was written to educate the public about the gap that exists in the quality control of anatomic pathology testing. All of this is consistent with the trend for providers to be transparent and report their quality metrics to the public, including patients.

—Jon Stone

Related Information:

Hormone Receptor Testing Volume 1: Investigation and Findings Commission of Inquiry on Hormone Receptor Testing

Precision Medical Treatments Have a Quality Control Problem

HER2 TESTS: How Do We Choose?

Cancer Drug May Elude Many Women Who Need It

American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer

Impact of Electronic Health Record Systems on Information Integrity: Quality and Safety Implications

His Doctor Said It Was Cancer. It Wasn’t. But the Lab Mix-Up News Came Too Late.

Up to 60,000 Cancer Test Results May Have to Be Reviewed After Women Wrongly Given the All-Clear

Over 30,000 Published Studies Could Be Wrong Due to Contaminated Cells

Netherlands University Researchers Question Validity of More Than 30,000 Published Scientific Studies; Findings Have Implications for Medical Laboratories

Agilent’s $2.2 Billion-Dollar Acquisition of Dako Likely to Shake Up the Anatomic Pathology and Histology Marketplace

Pathology laboratories that are customers of Dako should take notice of the coming change of ownership

Once again, a major player in histology and anatomic pathology tissue processing has been acquired. Yesterday it was announced that Agilent Technologies Inc. (NYSE: A), of Santa Clara, California, will pay $2.2 billion to acquire Dako, the cancer diagnostics company in Glostrup, Denmark. It is the largest acquisition in Agilent’s 13-year history.

The high price paid for Dako is just the latest confirmation that Wall Street investors consider molecular diagnostics and anatomic pathology to be a high-growth, profitable sector of laboratory medicine. With 2010 revenues of $340 million, Agilent will pay $2.2 billion, which is a 5.8 times multiple of Dako’s annual revenue.

Pathologists and clinical laboratory managers following the histopathology market will recall that Ventana Medical Systems, Inc., was acquired by Roche Holding AG (RHHBY) in February, 2008. The purchase price was approximately $3.4 billion, representing a multiple of 10.2 times Ventana’s 2007 revenue of about $290 million.
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Good News for Anatomic Pathology Laboratories: Tissue-Based Diagnostics Market Predicted to Double by 2016

Advanced histology staining equipment will capture a greater market share


There’s good news for anatomic pathologists in the forecast from one expert watching the U.S. market in equipment for clinical diagnostics. According to Winny Tan, Ph.D, a Senior Analyst with Frost & Sullivan, the increasing rate of cancer incidence in the U.S. will drive robust growth in tissue-based diagnostics.

She predicts that revenues from that segment will more than double by 2016, growing from the $1.029 billion in 2009 to $2.278 billion in 2016. Tan made her predictions in an article in the May 15, 2010 issue of Genetic Engineering News.

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PART TWO: Quebec’s Debate about Breast Cancer Test Errors Turns to Questions about Defining Accuracy of Pathology Laboratory Testing

Specialist physicians in Quebec question why the outside review of ER and HER2 breast cancer pathology test results used a 1% standard versus a 10% standard

Public debate in Quebec about inaccurate tests for breast cancer by the province’s pathology laboratories has turned attention to an area of pathology testing which is seldom discussed in public forums. It is the situation where there is often significant variability in rate of false positives and false negatives reported by different pathology laboratories performing the same tests for breast cancer and other diseases.

Quebec’s media coverage about problems with its pathology laboratories and inaccurate breast cancer tests was reported last week by Dark Daily in the e-briefing titled “PART ONE: More Debate in Quebec about How Pathology Labs Performed Inaccurate Breast Cancer Tests” . Here in Part Two, we describe how Quebec’s medical specialists are calling attention to another source of problems. This is how the use of various standards for evaluating breast cancer specimens can contribute to different rates of false positive and false negative results on pathology tests reported by pathology laboratories in the province.

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Digital Pathology Moves Forward with Two New Digital Imaging Products

Aperio Technologies and Applied Spectral Imaging announce new products in July

Two new digital imaging products launched this month show that vendors are advancing the capabilities of digital imaging and digital pathology systems. Each company’s new product announcement touts the value of computer-aided diagnosis and computer pattern recognition for anatomic pathologists.

On July 9, Aperio Technologies, Inc., of Vista, California, launched its Digital IHC Solution for immunohistochemistry that features integrated image analysis for quantification of breast cancer. Aperio says that this is the only commercially available FDA-cleared system that allows pathologists to run quantitative IHC image analysis while reading slides on a computer monitor.
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