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

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Biomarker Trends Are Auspicious for Pathologists and Clinical Laboratories

Few anatomical tools hold more potential to revolutionize the science of diagnostics than biomarkers, and pathologists and medical laboratories will be first in line to put these powerful tools to use helping patients with chronic diseases

There’s good news for both anatomic pathology laboratories and medical laboratories worldwide. Large numbers of clinically-useful new biomarkers continue to be validated and are in development for use in diagnostic tests and therapeutic drugs.

Clinical laboratories rely on biomarkers for pathology tests and procedures that track and identify infections and disease during the diagnostic process. Thus, trends that highlight the critical role biomarkers play in medical research are particularly relevant to pathology groups and medical laboratories.

Here’s an overview of critical trends in biomarker research and development that promise to improve diagnosis and treatment of chronic disease.

Emerging Use of Predictive Biomarkers in Precision Medicine

Recent advances in whole genome sequencing are aiding the development of highly accurate diagnostics and treatment plans that involve the development and use of Predictive Biomarkers that improve Precision Medicine (PM).

PM involves an approach to healthcare that is fine-tuned to each patient’s unique condition and physiology. As opposed to the conventional one-size-fits-all approach, which looks at the best options for the average person without examining variations in individual patients.

Predictive biomarkers identify individuals who will most likely respond either favorably or unfavorably to a drug or course of treatment. This improves a patient’s chance to receive benefit or avoid harm and goes to the root of Precision Medicine. (Image copyright: Pennside Partners.)

The National Institutes of Health (NIH) defines PM as “an emerging approach for disease treatment and prevention that considers individual variability in genes, environment, and lifestyle for each person.” It gives physicians and researchers the ability to more accurately forecast which prevention tactics and treatments will be optimal for certain patients.

Combining Drugs for Specific Outcomes

Cancer treatment will be complimented by the utilization of combination drugs that include two or more active pharmaceutical ingredients. Many drug trials are currently being performed to determine which combination of drugs will be the most favorable for specific cancers.

Combination drugs should become crucial in the treatment of different cancers treatments, such as immunotherapy, which involves treating disease by inducing, enhancing, or suppressing an immune response.

Biomarkers associated with certain cancers may enable physicians and researchers to determine which combination drugs will work best for each individual patient.

Developing More Effective Diagnostics

In Vitro diagnostics (IVDs) are poised for massive growth in market share. A report by Allied Market Research, states the worldwide IVD market will reach $81.3 billion by 2022. It noted that IVD techniques in which bodily fluids, such as blood, urine, stool, and sputum are tested to detect disease, conditions, and infections include important technologies such as:

Allied Market Research expects growth of the IVD market to result from these factors:

  • Increases in chronic and infectious diseases;
  • An aging population;
  • Growing knowledge of rare diseases; and
  • Increasing use of personalized medicines.

The capability to sequence the human genome is further adding to improvements in diagnostic development. Pharmaceutical companies can generate diagnostic counterparts alongside related drugs.

Biopsies from Fluid Sources

Millions of dollars have been spent on developing liquid biopsies that detect cancer from simple blood draws. The National Cancer Institute Dictionary of Cancer Terms defines a liquid biopsy as “a test done on a sample of blood to look for cancer cells from a tumor that are circulating in the blood or for pieces of DNA from tumor cells that are in the blood.”

At present, liquid biopsies are typically used only in the treatment and monitoring of cancers already diagnosed. Companies such as Grail, a spinoff of Illumina, and Guardant Health are striving to develop ways to make liquid biopsies a crucial part of cancer detection in the early stages, increasing long-term survival rates.

“The holy grail in oncology has been the search for biomarkers that could reliably signal the presence of cancer at an early stage,” said Dr. Richard Klausner, Senior Vice President and Chief Medical Officer at Grail.

Grail hopes to market a pan-cancer screening test that will measure circulating nucleic acids in the blood to detect the presence of cancer in patients who are experiencing no symptoms of the disease.

Clinical Trials and Precision Medicine

The Precision Medicine Initiative (PMI), launched by the federal government in 2015, investigates ways to create tailor-made treatments and prevention strategies for patients based on their distinctive attributes.

Two ongoing studies involved in PMI research are MATCH and TAPUR:

  1. MATCH (Molecular Analysis for Therapy Choice) is a clinical trial run by The National Cancer Institute. The researchers are studying tumors to learn if they possess gene abnormalities that are treatable by known drugs.
  2. TAPUR (Targeted Agent and Profiling Utilization Registry), is a non-randomized clinical trial being conducted by the American Society of Clinical Oncology (ASCO). The researchers are chronicling the safety and efficacy of available cancer drugs currently on the market.

New Tools for Pathologists and Clinical Laboratories

The attention and funds given to these types of projects expand the possibilities of being able to develop targeted therapies and treatments for patients. Such technological advancements could someday enable physicians to view and treat cancer as a product of specific gene mutations and not just a disease.

These trends will be crucial and favorable for clinical laboratories in the future. As tests and treatments become unique to individual patients, pathologists and clinical laboratories will be on the frontlines of providing advanced services to healthcare professionals.

—JP Schlingman

Related Information:

5 Trends Being Impacted by Biomarkers

Immuno-Oncology Stories of 2016

Bristol-Myers Leads Immune-Oncology Race but Merck, Astrazeneca and Roche Still Have Contenders

Five Companies to Watch in the Liquid Biopsy Field

Illumina Spinoff GRAIL to Trial Liquid Biopsies for Early Detection of Cancer

Illumina Forms New Company to Enable Early Cancer Detection via Blood-Based Screening

A to Z List of Cancer Drugs

Personalized Medicine and the Role of Predictive vs. Prognostic Markers

Understanding Prognostic versus Predictive Biomarkers

NCI-MATCH Trial (Molecular Analysis for Therapy Choice)

Six Months of Progress on the Precision Medicine Initiative

Trends in Genomic Research That Could Impact Clinical Laboratories and Anatomic Pathology Groups Very Soon

Genomics is quickly becoming the foundational disruptor technology on which many new and powerful clinical laboratory tests and procedures will be based

Genomics testing has become accessible, affordable, and in some instances, life-saving. Clinical laboratories and pathology groups are handling more genomic data each year, and the trend does not appear to be slowing down. Here are current trends in genomic research that soon could be bringing new capabilities to medical laboratories nationwide.

Improved Data Sharing

Sometimes genetic tests don’t translate into better outcomes for patients because medical labs are limited in how they can share genomic data. Thus, experts from various disciplines are seeking ways to integrate genomic data sharing into the hospital and laboratory clinical workflow in a form that’s easily accessible to doctors. (more…)

New Chinese Paper-Based Test That Reveals Blood Type in Mere Seconds with 99.9% Accuracy Could Impact Medical Laboratories in the US

Low-cost assay would be a boon in remote areas, war zones, and emergency departments by providing fast and reliable blood typing without the need for specialized clinical lab equipment, and by reducing demand on type-O blood supplies

Chinese researchers claim to have invented an inexpensive point-of-care (POC), paper-based blood test that can determine a patient’s blood type in seconds and with nearly perfect accuracy.

Such an inexpensive, simple-to-use assay would be game changing for pathology groups and clinical laboratories since traditional tests to classify blood into blood groups remain time consuming and labor intensive despite recent advances.

Changing Colors Reveal Blood Type

Hong Zhang and colleagues at Third Military Medical University in Chongqing, China, published their results in the March 15, 2017, issue of Science Translational Medicine. (more…)

University of Washington School of Medicine Study Finds Two Different Next-Generation Genetic Tests Can Produce Widely Different Results in the Same Patient

Genetic tests performed by FoundationOne and Guardant360 come to different conclusions in study of nine cancer patients whose study findings are of interest to pathologists

It’s an understatement to say that tests run by clinical laboratories and pathology groups must be accurate, consistent, and reliable. Thus, research conducted at the University of Washington School of Medicine (UW Medicine) in Seattle, which concluded that genetic tests from two different lab companies produce different results when given to the same patient, is of critical importance.

Oncologists and medical laboratory leaders must have confidence in the results of genetic tests performed on thousands of patients each year. However, according to a UW Medicine statement, a preliminary study comparing two commercially available next-generation genetic sequencing tests in the same cancer patients showed results that could be “markedly” different, depending on the tests performed. (more…)

Pathologists Performing Molecular Autopsy in Cases of Sudden Unexpected Death Could Identify Genetic Clues That Help Surviving Family Members Assess Their Own Risk

Pathologists could benefit if postmortem genetic testing becomes more commonplace following incidents of sudden unexpected death

Pathologists are discovering that molecular autopsy, also called postmortem molecular testing, could boost the chance of discovering the likely or plausible cause of sudden unexpected death, according to preliminary results from a study published in the Journal of the American Medical Association (JAMA).

Researchers led by Ali Torkamani, PhD, Director of Genome Informatics at the Scripps Translational Science Institute (STSI) and Assistant Professor of Molecular and Experimental Medicine at the Scripps Research Institute, sequenced samples from 25 sudden death cases. They identified: (more…)

Pathologists and Clinical Laboratories May Soon Have a Test for Identifying Cardiac Patients at Risk from Specific Heart Drugs by Studying the Patients’ Own Heart Cells

Stanford University School of Medicine researchers grew heart muscle cells and used them, along with CRISPR, to predict whether a patient would benefit or experience bad side effects to specific therapeutic drugs

What would it mean to pathology groups if they could grow heart cells that mimicked a cardiac patient’s own cells? What if clinical laboratories could determine in vitro, using grown cells, if specific patients would have positive or negative reactions to specific heart drugs before they were prescribed the drug? How would that impact the pathology and medical laboratory industries?

We may soon know. Researchers at Stanford University School of Medicine (Stanford) have begun to answer these questions. (more…)

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