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

Hosted by Robert Michel

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

Hosted by Robert Michel
Sign In

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

Hoping to Become Heavyweights in Healthcare Big Data, IBM Watson Health Teams Up with Siemens Radiology and In Vitro Diagnostics Businesses

Big data offers new opportunities for healthcare providers, clinical laboratories, and pathology groups, and this new alliance hopes to accelerate big data capabilities

Big data has the potential to deliver unprecedented insight into optimizing the patient care experience and managing outcomes for healthcare providers. That is particularly true for clinical laboratories, and pathology groups. Yet, with the sheer amount of data generated by today’s ever-expanding menus of diagnostic procedures, communicating this data between systems and analyzing data at high-levels still presents challenges.

To help healthcare organizations jumpstart their Big Data programs, key stakeholders are joining forces. One such alliance involves Siemens Healthineers and IBM Watson Health. In an October 2016 press release, the two organizations announced a five-year global strategic alliance aimed at helping healthcare professionals optimize value-based care that leverages increasingly complex data collected for use in precision medicine.

What should intrigue pathologists and medical laboratory managers about this new alliance is the fact that Siemens Healthineers owns two of the world’s largest businesses in radiology/imaging and in vitro (IVD). Thus, it can be expected that the alliance will be looking to identify ways to combine radiology data with clinical laboratory data that produce knowledge that can be applied to clinical care. (more…)

Offsetting the Rising Costs of Hospital Laboratory Reference and Send-out Testing

Baystate harvests annual savings of 20%+ from simple strategies and steps

In today’s depressed economy, hospital laboratories are scrambling to control costs, reduce unnecessary spending, and get more for every dollar they spend. That is why the constantly-rising cost of reference tests and send-out referrals are now a prime target for laboratory budget-cutters across the United States.

Every laboratory’s reference/send-out test program is a potential budget-buster, for three reasons familiar to every lab director.

(more…)

;