The self-monitoring/self-test market is expected to swell to $19 billion by 2019, offering opportunities for pathologists and clinical laboratories to advise patients and ensure the proper use of home tests
Might the future of clinical laboratory tests be sitting on the shelf at your corner pharmacy right now? Patient self-testing and screening kits continue to garner the approvals of Consumer Reports’ medical advisors.
That’s happening because the Food and Drug Administration (FDA) continues to clear many do-it-yourself tests that traditionally were performed in medical laboratories by qualified personnel, much to the chagrin of some doctors.
Empowered healthcare consumers are checking their cholesterol, monitoring their diabetes, and more, using health screening kits that range from $8 to $175, according to a Consumer Reports on Health article, which advised consumers to use self-tests judiciously and share the results with their physicians.
Self-Test Market for Clinical Laboratory Tests to Expand by Billions
Research published in the Annals of Internal Medicine suggests that one of the most common at-home tests—the fecal immunochemical test (FIT) for colon cancer screening—is an effective and suitable alternative to invasive colonoscopy.
“This is the future of medicine. People want to be more in charge of their own healthcare,” said Eric Topol, MD, Cardiologist and Director of the Scripps Translational Science Institute in La Jolla, Calif., in the Consumer Reports story.
Eric Topol, MD (above) is a cardiologist and Director of the Scripps Translational Science Institute in La Jolla, Calif. He told Consumer Reports on Health that the trend and growth of do-it-yourself health screening tests is a sign that people want control of their healthcare. (Photo Copyright: The Washington Post.)
In fact, a BCC Research report suggests the global health self-monitoring technology market reached nearly $3.2 billion in 2014 and is expected to grow to nearly $19 billion by 2019.
Okay to Try These Tests at Home, says Consumer Reports
Tests for the following health indicators (cleared by the FDA) were deemed by Consumer Reports’ medical advisors to be worth consideration by consumers:
• Cholesterol;
• Colon Cancer;
• Hepatitis C;
• HIV;
• Urinary Tract Infections; and
However, the Consumer Reports article advised readers to avoid home testing for the following conditions:
• Allergies;
• Menopause (exempt from FDA approval);
• Thyroid Disease; and
Why Buy Medical Laboratory Tests at the Corner Drug Store?
In addition to seeking control over their healthcare, patients are also motivated by convenience and privacy, noted a Lab Tests Online article. As well, consumers seek less-invasive approaches to tests such as colonoscopies.
While physicians pitch rectal screening to their patients who are over 50, the Centers for Disease Control and Prevention (CDC) says one in three adults don’t get a colonoscopy because of its invasive nature.
Effective Home-Based Test Alternative to Colonoscopy
FIT, the home-based method for detecting colon cancer through a person’s stool, was the subject of research published earlier this year in the Annals of Internal Medicine. Researchers from Kaiser Permanente Northern and Southern California involved 323,349 health plan members in the first of four rounds of FIT.
FIT screening detected about 85% of colon cancer cases in the first round and 73 to 78% of cases in follow-up rounds, the study noted.
The researchers found that FIT was “highly sensitive for detecting” colon cancer, and that people were more likely to participate, as compared to colonoscopy, reported Medical Daily.
“Annual programmatic FIT screening is feasible and effective for population-level colon rectal cancer screening,” the researchers wrote in the Annals of Internal Medicine.
Study of Home-Based HIV Testing Underway
Consumer Reports researchers also note that HIV home health screening tests can appeal to people at high risk who seek privacy. The effectiveness of at-home HIV testing and counseling to improve the lives of gay couples is the subject of a University of Michigan (U-M) study trial announced earlier this year, according to a U-M statement.
The U-M study, called Project Nexus, is believed to be the first of its kind to use telemedicine in conjunction with in-home testing and video counseling to help male couples manage HIV-related issues. “There’s a pressing need to increase testing and communication about HIV risk among male couples,” said Robert Stephenson, PhD, U-M Professor of Health Behavior and Biological Sciences, and the study’s principal investigator.
For pathologists and medical laboratory leaders the message is clear: people are increasingly bypassing the doctor’s office for some diagnostic test orders. This circumvents the clinical laboratory and eliminates long wait times to receive results.
In the end, medical laboratories remain the professional source for medical testing. It would thus benefit all clinical laboratories to have a strategy that enables pathologists and lab leaders to reach out beyond the lab and help consumers use and interpret the self-testing they want or need.
—Donna Marie Pocius
Related Information:
Fecal Immunochemical Test Program Performance over Four Rounds Annual Screening
Health Self-Monitoring Technologies Global Markets Report
Colon Cancer Screening: Do-It-Yourself Test May Be Effective Alternative to Colonoscopy
New Study Tests the Effectiveness of At-Home HIV Testing for Male Couples
FDA Permits Marketing of First System of Mobile Medical Apps for Continuous Glucose Monitoring
