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Why Healthcare Experts Critical of Direct Access Testing Advise Clinical Laboratories to Take Precautions

Test ordering and results interpretation can confuse the public says Dartmouth Institute, which is why some clinical laboratories limit the types of lab tests that people can request

Giving consumers direct access to medical laboratory testing continues to be a subject of some controversy. One factor in this debate is Theranos, which brought much attention to direct access testing, followed by extensive news coverage in recent months of its problems with reporting accurate clinical laboratory test results.

Concerns about allowing consumers to have direct access to lab testing were the subject of a recent National Public Radio (NPR) Shots Health News story. Several medical experts were interviewed and described why they had concerns about direct access testing (DAT).

One such expert is H. Gilbert Welch, MD, MPH, Professor of Medicine, Community and Family Medicine at The Dartmouth Institute (Dartmouth). According to Welch, DAT could contribute to over-diagnosis and give people an inaccurate impression of what good health actually means.

Nevertheless, the number of patient-ordered direct access tests continues to increase, indicating a public demand that will affect the workflows of clinical laboratories nationwide.

Medical Laboratory Testing is Not Health

“There’s a growing sense that the path to health is through [laboratory] testing, but you don’t test yourself to health,” Welch stated in an NPR interview. He added that “encouraging the ‘worried well’ to order their blood test feeds that mindset.”

According to the American Society for Clinical Pathology (ASCP), the “worried well” are people who want to be involved in monitoring their healthcare. The ASCP calls for patients who engage in DAT to select CLIA-certified (Clinical Laboratory Improvement Amendment) labs and to have their test results reviewed by primary care doctors.

DAT is Popular with Clinical Labs, but Pathologists Suggest Oversight

DAT enables consumers to request medical lab tests from clinical laboratories without doctors’ orders. It is legal in 29 states and the District of Columbia; 13 states require a physician pre-authorization; and nine others limit the number of tests people can obtain, explained a Lab Tests Online statement.

H. Gilbert Welch, MD, MPH, Professor of Medicine, Community and Family Medicine, The Dartmouth Institute, told NPR that health is “more about how you move, what you eat, and finding joy and purpose in life,” as opposed to testing. (Photo copyright: Fanatic Cook http://fanaticcook.com/2015/04/08/dr-h-gilbert-welch-health-is-about-more-than-a-bunch-of-physical-measurements/.)

H. Gilbert Welch, MD, MPH, Professor of Medicine, Community and Family Medicine, The Dartmouth Institute, told NPR that health is “more about how you move, what you eat, and finding joy and purpose in life,” as opposed to testing. (Photo copyright: Fanatic Cook.)

For a growing number of medical laboratories and websites offering blood testing to consumers, DAT is a popular customer service. But prior to taking orders from the consumers, some pathologists say it is important to first carefully select the menu of clinical laboratory tests that will be directly available to the public.

Medical Laboratory Test Ordering and Results Reporting Could Confuse Patients

Opponents also say DAT can lead to confusion among consumers about which tests are appropriate to order. Consumers can often find it challenging to interpret and understand the lab test results. Another source of confusion can be false positives.

Norman Paradis, MD, is an Emergency Medicine Physician and Professor of Medicine at Dartmouth-Hitchcock Medical Center. He suggests that even medical students are challenged in test ordering procedures. “If it’s difficult for them, it’s even harder for the layperson,” Paradis stated in the NPR article, adding, “If you simply run medical tests [on] large numbers of people who don’t have the signs and symptoms of a certain disease, many of the results you get will be false positives.”

DAT Is a Big Business

DAT has grown from a $15-million business in 2010 to a $131-million business in 2015. That’s according to a New York Times blog post about DAT that cited data from the January Kalorama report, “The Market for Direct-to-Consumer Genetic Testing and Routine Laboratory Testing.”

According to Kalorama, among the publicly-held market leaders in DAT are:

Laboratory Corporation of America (NYSE:LH); and

Quest Diagnostics (NYSE:DGX).

That’s due to their geographic breadth. Among the privately-held DAT leaders include:

23andMe, a personal genomics and biotechnology company located in Mountain View, Calif.;

Sonora Quest Laboratories, located in Tempe, Ariz., and experiencing market success on a regional basis; and

WellnessFX, located in San Francisco, Calif., and operates as a subsidiary of Health Elements, LLC.

Sonora Quest Laboratories Sets Criteria for DAT Menu

Sonora Quest launched the patient-ordered lab test service My Lab ReQuest in September 2015, just a few months after Arizona’s Governor Doug Ducey signed DAT into state law.

My Lab ReQuest’s test menu lists 39 tests for patient orders. Prices are posted alongside test descriptions. The tests include:

● Expanded Health Profile (including lipid panel, comprehensive metabolic panel, glucose)-$37;

Complete Blood Count (CBC)-$11;

● Screen for diabetes-$7;

● Cardio health-$21;

Hepatitis C -$29; and

● Thyroid-$26.

Sonora Quest Laboratories, a joint venture between Banner Health System and Quest Diagnostics Incorporated, includes far more tests on its full diagnostics menu, which has more than 1,000 tests.

“But just because you can perform a laboratory test, doesn’t mean you should offer it to consumers,” said Robert Stern, MD, Sonora Quest’s Medical Director, in a statement.

In an interview with The Dark Report (Dark Daily’s sister publication), Stern noted that though medical laboratory tests for some diseases and conditions are popular among consumers, the test results are “complex” and “difficult to interpret,” therefore, My Lab ReQuest does not offer those tests to DAT customers.

The test for Celiac disease, for example, is often requested by people who want to avoid it by, in part, going gluten-free. However, Stern says it can be difficult to interpret the lab test results related to the diagnosis of Celiac disease. “The diagnosis is complex because the patient’s IgA level [blood level of immunoglobulin A] will affect what other tests mean when identifying Celiac disease,” Stern told The Dark Report.

False Positives Can Lead to Over-Utilization of Clinical Lab Tests and Increased Costs

Like Paradis, Stern is concerned about consumers ordering medical laboratory tests that are likely to report false positives. An example Stern gave The Dark Report is a person in Arizona getting a test for Lyme disease, which is not endemic there. “Therefore, if a consumer gets the test and has not traveled to an area where Lyme disease is endemic, then a positive result is almost certainly a false positive,” Stern said.

He goes on it state that, based on the results of the first test, the patient may then order additional tests, even though the initial test should not have been run in the first place. “In laboratory medicine, it’s called the ‘Ulysses Syndrome’ when a patient orders an inappropriate test, gets a result that he or she doesn’t know what to do with, and then gets more testing,” he observed. “More lab testing leads to more results back. So, rather than helping to control healthcare costs, this kind of random or unselected testing can drive up costs—even though lab tests as a percentage of overall healthcare spending is relatively low,” Stern noted.

Give People Results with Consult Access

One source of direct access testing does more than just list clinical laboratory tests on its website that consumers can purchase. WellnessFX offers direct consumer access to blood tests along with phone consultation with healthcare practitioners and data tracking. Test packages range in price from the basic at $78 to premium at $925. The basic package, described on the company’s website, includes 25-plus biomarkers, including:

● Heart health;

● Complete blood count;

● Basic thyroid; and

● Blood sugar testing.

In the New York Times post, Paul Jacobson, Chief Executive Officer of WellnessFX, stated, “You need to offer solutions to people; otherwise, you’re just giving them meaningless information.”

However, patients are not required to review direct access test results with physicians, and that is cause for concern among laboratory professional associations, reported Lab Tests Online.

It should be noted that direct access testing generally refers to a consumer who, on his or her own initiative, wants to order medical laboratory tests without a physician’s lab test order. There is another segment of consumers who lack health insurance or have high-deductible health plans. These consumers typically have a lab test order from their physician and are seeking to obtain those tests at the lowest possible price. Many clinical laboratories offering DAT also serve this other type of patient.

Donna Marie Pocius

Related Information:

DIY Blood Tests? There’s a Downside to Ordering Your Own

Dr. H. Gilbert Welch: “Health Is About More Than a Bunch of Physical Measurements”

New Arizona Law Expands Number of Lab Tests Consumers Can Order on Their Own, Fuels Debate

Direct-to- Consumer Lab Tests, No Doctor Visit Required

The Market for Direct to Consumer Genetic Testing and Routine Laboratory Testing

Sonora Quest Starts Direct Access Testing Program

Direct Access Testing

Should Patients Have Access to all Laboratory Tests—How Sonora Quest Laboratories Selects Tests It Considers Appropriate for Its DAT Menu

It’s No Surprise Why More Consumers Use the Internet to Order Lower-Priced Clinical Laboratory Tests

Quest Diagnostics Leaves the Direct Access Testing Market

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