By Bill Kelly

Consumers are directing healthcare in many ways, but ordering clinical testing was, until recently, the exclusive purview of physicians. That’s changing as many services now exist for patients to order tests without a physician’s okay. The global direct to consumer (DTC) laboratory testing market totaled $208 million in 2018. Growth historically has been slower due to a lack of regulatory oversight and concerns within the industry. Strong growth is expected throughout the forecast period due to easing of the regulatory processes for DTC laboratory tests and increasing consumer demand for both direct-to-consumer routine clinical laboratory tests and genetic tests.

"Medical consumers using the internet is yesterday’s story, the inculcating of that internet searching into the doctor-patient and payor relationship is the reality today,” said Bruce Carlson, publisher at Kalorama Information. “It’s not just that consumers are more informed and more cost-conscious; the increase in high deductible insurance plans requires that individuals ask more.“

Vendor actions are enlarging the trend as well, Kalorama notes. On the genetic side, the popularity of 23andMe.com, and online genetic testing is driving a parallel genetic health testing trend. But routine testing is also driven by the new diagnostic consumer. Companies such as Quest and LabCorp have embraced the DTC concept and that is a key market driver. Both companies have entered into collaborations with other retail and pharmacy outlets to accommodate consumers and are seeing success in these areas.

LabCorp partnered with Walgreens stores to add patient testing centers. The company said they experienced a 10% increase in the number of patients seen compared to regular LabCorp sites. As a result, LabCorp and Walgreens are opening at least 600 new patient service centers across the United States. Quest Diagnostics is also competitive. Quest has also partnered with retail stores such as Safeway in 2015 and Walmart in 2017 to further comprehensive patient-centered healthcare offering DTC routine clinical testing. According to a company representative, Quest expects to have well over 200 patient service centers in Safeway and Walmart locations by the end of 2018.

Sonora Quest is a subsidiary of Laboratory Sciences of Arizona. The company has just started a new service, My Lab ReQuest, which is a DTC service including a limited menu focused on wellness health profiles. It also includes screening for allergies, diabetes and cardiovascular health. Consumers can order tests either online or at Sonora’s patient service centers.

The growing industry for direct to consumer laboratory testing may promote awareness of health issues and genetic diseases, which will allow patients to take a more proactive role in their healthcare. With advances in technology, the completion of the sequencing of the human genome and the pressures of capitalism, direct to consumer lab testing is becoming increasingly popular. Still, clinical laboratories are an essential part of the health industry. It is estimated that approximately 80% of physician’s diagnoses are a result of laboratory tests. In addition to diagnosing patients, clinical lab testing is performed to evaluate disease progression, monitor drug treatment and conditions, determine individual therapy, and several other reasons.

Several trends are continuing to shape the direct to consumer laboratory testing market including the growing demand for early disease detection and diagnosis, personalized medicine, importance of disease monitoring and expanded technologies. But it is not without growing pains. The industry has suffered setbacks such as FDA warning letters and a good deal of debate in the medical community. The industry, however, appears to be making progress. Companies have employed different strategies and business models to gain a stake in this valuable market. There is obviously a growing market as consumers thirst for knowledge of their heritage and ethnic background as AncestryDNA sports a database of over 4,000,000+ and 23andMe has a database of over 2,000,000. However, 23andMe is the only consumer testing company that is FDA cleared to offer genetic health risk tests.

With the increased use of the Internet for medical information, patients have become medical consumers, not just patients. This has created a change in the doctor/patient relationship as individuals become more knowledgeable about their own health and want more control over their personal information and treatment decisions.

What do you think?What are your thoughs on genetic testing kits? What about the ethics of direct-to-consumer genetic testing? Let us know in the comments below.


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