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Compliance In Focus
Posted by John Lehmann on Tue, Jun 4, 2019

Biomarker Testing Improves Cancer Screening & Treatment

Biomarker testing for cancer assists with early detection and helps physicians monitor treatment.


Recent advances in this area—including liquid biopsies and breath tests—could lead to faster, less invasive cancer screening, as well as more personalized and precise treatment.

Here are a few of the most promising developments.


Common Types of Biomarker Testing

Biomarker testing is an element of in vitro diagnostics that uses molecules in the body to assess health and identify the presence of disease.

Common types of biomarker testing for cancer include chromosome tests, gene tests and biochemical tests, which detect the presence of abnormal proteins created from gene mutations.

For instance, patients with certain types of cancer have two copies of a gene that makes a specific protein, so they have an increase of that protein in their blood.

In addition to being used to detect cancer, biochemical tests can show whether cancer treatment is working.

Recent Advancements In Biomarker Testing

Clinical trials are using biomarker testing to make cancer treatment more personalized and precise, which could reduce treatment time and minimize some of the harmful side effects.

Here are a few examples:

Beat AML Master Trial

Acute Myeloid Leukemia (AML) is a type of cancer that begins in the bone marrow and multiplies quickly. The cancerous cells block the production of normal cells, resulting in a lower number of healthy red and white blood cells and platelets.

This causes anemia, compromised immunity and easy bruising or bleeding, among other symptoms.

AML is difficult to treat because it is not a single disease, but a group of more than 10 major subtypes and rare mutations. The Leukemia and Lymphoma Society is in its third year of a clinical trial that aims to help AML patients 60 and older. Patients are screened for genetic changes driven by the disease and then assigned a specific therapy based on their genetic profile.

Using Biomarkers To Treat Non-Small Cell Lung Cancer

Lung cancer has been the leading cause of cancer-related deaths for decades. More than half of lung cancer patients die within one year of diagnosis, and fewer than 20 percent survive for five years.

Non-small cell lung cancer (NSCLC) is the most common type, accounting for 85 percent of all lung cancer. It’s also highly heterogeneous and difficult to treat. Biomarkers can help physicians better understand the molecular biology of the cancer in each individual patient. This has led to the development of two main types of targeted therapies so far. These targeted treatments have the potential to reduce the costs and side effects associated with traditional chemotherapy.

Using Biomarkers To Detect Gastric Cancer

Gastric cancer is the second-leading cause of cancer deaths worldwide. Like AML and NSCLC, it’s highly individualized, which makes it difficult to treat. Symptoms rarely appear until gastric cancer is in its advanced stages, which makes early detection critical.

Several potential diagnostic biomarkers have been identified to detect gastric cancer, although further testing is needed.

The Future of Biomarker Testing

In addition to aiding diagnosis and treatment, biomarker testing is becoming less invasive. New methods include liquid biopsies for cancer detection. Liquid biopsies use bodily fluids to detect cancer biomarkers, which provide a faster, easier and more cost-effective alternative to tissue removal.

In addition to being used to detect cancer, they may offer an easier way for physicians to monitor treatment.

"Liquid biopsies, in their myriad forms, are revolutionizing laboratory testing,” said Garth D. Ehrlich, editor in chief of Genetic Testing and Molecular Biomarkers, in a recent Genetic Engineering News article. “They will be the principal means of monitoring the body's health and homeostatic mechanisms within the next decade.”

Breath testing is another revolutionary biomarker screening method. A new breathalyzer platform being used in clinical trials has the potential to remove the risks and discomfort of traditional cancer screenings while making it easier to monitor treatment.

Biomarker testing offers tremendous opportunities for clinical researchers.

It’s an area of special interest for us at IMARC Research, as our team has significant experience with in vitro diagnostics. In the past five and a half years, our team has monitored three clinical cardiac biomarker assay studies involving almost 3,000 subjects for a leading global in vitro diagnostics (IVD) company. These studies have been used in support of 510(k) clearance in the US. We have also monitored two studies which involved an assay identifying Vitamin D values, including the reference range, and will be starting another testing study examining anti-coagulation this fall.

If you’d like to know more about our experience with in vitro diagnostics or other areas of therapeutic expertise, download our guide to working with us or contact us today.

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Topics: medical device trends


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