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BENEFITS OF TESTING, TRENDS AND FUTURE OF DIRECT ACCESS TESTING.
Laboratory testing has changed dramatically in the past 20 years. Not
only are there more testing options based on new technologies and
knowledge in the medical field, but many individuals are more aware
of the information that these tests can provide. Three large areas of
testing include clinical testing, drug testing and DNA paternity and
genetic testing. All of these tests have grown in both awareness and
usage by consumers and they have supplied people with critical
information that has improved lives by preventing and managing
disease, making our workplaces safer and identifying biological
relationships to provide for our children and give us information about
our genetic makeup.
The ability to research medical conditions on the internet prompts
people to search for diseases and syndromes that match their
symptoms and then to ask their health care provider to perform tests
or to seek them out independently. Once the test results return,
patients can ask pointed questions about what the results mean and
what the impact will be on their health.
Consumers are also asking for safety in the workplace and on our
highways creating the need for drug and alcohol testing, both pre-
employment and throughout the life of a job for some employees. A
drug-free workplace policy encourages employees to behave more
responsibly and deters them from drug use, especially if the policy is
enforced with drug testing. The American public can feel a little more
secure knowing that drivers, medical staff or co-workers have been
discouraged from drug use while on the job.
Paternity testing and other types of genetic testing are on the rise and
are more accurate than ever before. Welfare reform has prompted
changes in how parentage is identified when children are born and
encourages DNA paternity testing to ensure paternal support of the
children of unwed mothers. Because the tests are so accurate,
courts rely on them to determine child support, custody and even ANYLABTESTNOW.COM
THE CURRENT TRENDS IN LABORATORY TESTING
by mAureen young
JuNe 2014
[PArT ONe Of TWO]
For more information, please visit
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BENEFITS OF TESTING
immigration. In addition, more people have become interested in their own genetics, either to find out whether they are at risk
for certain cancers or diseases that are hereditary or to learn more about their ancestry. Advances in the technology for genetic
tests have provided a wider range of tests and more detailed information.
Current changes in our health care system caused by the Affordable Care Act (ACA) have prompted people to evaluate where
their health care dollars are being spent and then to make changes to the services they buy and to question health care
decisions more closely. A more informed public is more likely to ask their health care providers why certain tests are performed
and not others and to track their test results over time. The current focus on preventive care and testing allows for early
detection of disease as well as the ability to avoid certain diseases, such as type 2 diabetes.
While there are individuals who would prefer not to know that they have, or are at risk for, a specific disease, the trend is toward
greater awareness of our health. The public is bombarded with information and commercials that pit healthful living and
preventive medical and lifestyle care with bad habits and unhealthy options. The news and the marketing industry promote
health and wellness through healthier food, gym memberships and anti-aging or weight loss programs. This information is
interspersed with ads for fast food, which tries to position some of its meals as nutritious, and sedentary lifestyles centered
around an abundance of television shows that contribute to our national epidemic of obesity and poor health. With both of these
media influences battling for attention there is always a need for laboratory tests that can get people back on track by helping to
influence them to make healthier choices.
Benefits of TestingThere are many reasons that people are willing to seek out a specific test that their health care professional may not have
recommended. Organizations may also request or even require that employees obtain specific tests. The tests requested by a
company for its employee is usually based upon the concept that the test will save them money in insurance premiums either
by deterring employees from using drugs or alcohol or by encouraging them to take better care of themselves by using tests that
highlight health issues which are preventable with medication or lifestyle changes. Some of the reasons that people seek out
laboratory tests include:
1. The Quest Drug Testing Index (DTI) shows trends in drug abuse and misuse and has found high patterns of misuse
of drugs in women and men of all ages and health plan categories. This information often causes healthcare providers
and policy makers to take additional measures to educate patients about the dangers of prescription drug misuse and to
monitor them for medication compliance.
2. The early detection of disease and the prevention of further disease, side effects and even death, encourages many
people to seek out tests, both clinical and genetic.
3. Testing allows for the ongoing monitoring of chronic disease and helps patients and their healthcare providers to know if
treatments are effective in the management of disease.
4. Paternity testing is currently a key piece of managing child support and is sought out not only by men who are required
to support children they believe may not be theirs but by courts when there is doubt as to parentage with regards to
custody and child support decisions.
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TRENDS IN DIRECT ACCESS TESTING
The internet has been a boon for individuals who want to learn more about
their own health and how to improve it or to prevent disease. Some claim that
it may be too much of a good thing. The American Association for Clinical
Chemistry (AACC) published an article titled “The Google factor: Are the
Worried Well Making Healthcare Sick?”1. The author states that “for the
worried well, the Internet can turn a bout of fatigue into an opportunity to think
about poisonings, malnutrition, and cancer.
Patients don’t bear all the blame, however. The u.S. healthcare industry
promotes overtesting in outpatients because it is primarily based on a fee-
for-service system. even labs play a role in overutilization because, to the
extent that they participate in fee-for-service medicine, overutilization can
provide significant financial benefits.” A Washington Post article in June of
2014 described a health research group’s opposition to hospitals’ offerings
of low-cost cardiovascular tests and screenings. The group, Public Citizen,
stated that for many people the tests are unnecessary and can cause undue
worry and medical procedures. However, an opposing opinion is that for those
people who are at a high risk, either due to lifestyle factors or heredity, these
tests can make them aware of their options for prevention and treatment of
heart attack or stroke.
The availability of tests and medical information to the general public has
contributed to our ability to make more informed health care decisions for
ourselves. removing health care providers from some of the decisions that we
make regarding health puts us in the driver’s seat and gives us more control.
While the large amount of information and testing that consumers now have
access to can be overwhelming and cause some people to jump on the testing
bandwagon, the benefits of increased knowledge can be used to improve
health care outcomes for many people.
“…Direct access testing (DAT), also known as direct-to-consumer (DTC)
testing or patient-authorized testing, has been growing in popularity over the
past several years…DAT is a reflection of Americans’ focus on health and
preventive medicine, offering the opportunity for patients to take a more active
role in their own health care.”2 DAT, which has been available for decades, is
permitted in most states, and includes over the counter home tests, such as
pregnancy tests. One of the major benefits of these tests is that a prescription
or doctor’s order is not required, saving consumers the time and expense of a
visit to the doctor. The home tests originally available in drugstores expanded
to include walk-in laboratory tests that offer a wide range of screenings.
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Many of the tests available at retail or wellness centers are basic, simple tests
for general health such as complete blood counts (CBC), cholesterol or lipid
panels, throat and urine cultures, diabetes screenings (blood glucose tests),
chemistry panels, PSA tests for prostate cancer, thyroid tests, HIV antibody
tests, blood typing, pregnancy tests and urine drug screens. Some laboratories
have expanded their offerings to include genetic tests for paternity or broader
ancestry information.
Tests like these provide valuable information and the ease of access provides a
simple way for consumers to track and monitor their health and manage their
health conditions. Direct access testing also allows consumers to obtain tests
that are convenient and/or anonymous that they might otherwise avoid or not
consider. Some people are willing to pay higher rates for convenience and
anonymity to obtain the information they need to manage their health.
One drawback of obtaining a test independently is that a physician isn’t
there to interpret the results for the consumer. Labs are required to provide
reference ranges so that individuals are able to tell if the test results are
abnormal. This helps consumers but may also cause significant stress or
anxiety if the test provides new information about a health condition. results
that are out-of-range may need to be interpreted by a healthcare provider,
who can provide a bigger picture based on the patient’s individual clinical
signs, symptoms and medical history to guide patients in the management of
disease. Additionally, most insurance companies do not cover tests that are
not ordered by a physician so individuals will have to pay out-of-pocket for DAT
testing.
The diagnostic and medical laboratories industry has benefited directly from
the shift during the past 5 years from attempts to cure disease and treat it, to
the detection and prevention of disease and personalized care.3 This trend
toward preventive care stimulates the demand for industry services as more
physicians monitor patients’ blood and tissue and use MrI technology to test
for health issues. Testing supports physicians’ diagnostic abilities and is part of
the full range of medical services that includes prevention, diagnosis, treatment
and monitoring.
The recession created reduced industry revenue growth and fewer individuals
were willing to purchase the health insurance offered through their employers.
This is expected to reverse and the diagnostic and medical laboratories
industry will benefit from healthcare reform and the growing aging population,
boosting revenue. Older Americans tend to develop heart disease, liver
disease or cancer as they age, spurring the elderly to be tested more frequently
for these diseases.
TRENDS IN DIRECT ACCESS TESTING
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CHANGES IN HEALTHCARE
Healthcare is in the midst of huge changes due to both the ACA and medical
advances. robert L. Michel, editor-in-Chief of the Dark report presented to
the National Lab Training Conference V describing changes in health care
and laboratory medicine that he expects to see by the year 2020.4 During
his presentation in 2009 he stated that “knowledge based” lab testing
providers is a wide open segment. In Mr. Michel’s view the utilization of lab
tests will skyrocket over the next decade for several reasons:
1. Currently those under the age of 65 get 2 lab tests per year, while
those over 65 obtain 9 or more lab tests per year on average. There
are 80 million baby boomers rapidly advancing the age of 65+.
2. Middle class patients want access to healthcare and the latest
technology.
3. People are willing to pay for lab tests just as they willingly pay their
dog and cat veterinary bills today.
4. The health of Americans is worsening.
5. We are seeing a shift from reactive to proactive medicine.
6. Personalized medicine is a paradigm shift in healthcare and
Americans want to be treated individually and not “just like everyone
else”. The move toward personalized care is based on each individual
patient’s specific health factors.
7. Testing has become easier with fast, point-of-care tests.
Interest in Direct Access Testing (DAT), in which consumers order tests
directly from the lab without a doctor visit or consultation, has been
fueled by greater consumer access to medical information, direct-to-
consumer advertising and an emphasis on consumer empowerment.
“Laboratory medicine will play an ever greater role in repairing the fractured
health care system as stakeholders increasingly demand scientific evidence
for clinical decision making and strategies to address care quality, outcomes
and cost.”5 While this raises concerns about misinterpretation of test results,
it also provides an opportunity for laboratories to provide interpretative
services to help consumers understand their results rather than relying on
a doctor to interpret results. Between 1998 and 2006 revenues from DAT
have grown 40% (not adjusted for inflation) and spending growth on lab
tests rose 7% annually from 2006-2008. The majority of tests (66%) are
clinical pathology tests. Pharmacogenomics, tests that look at a person’s
genetics to determine how they will respond to a particular drug, has seen
the largest growth, followed by oncology or cancer testing. from 2009 to
2014 laboratory testing has seen 3% growth annually with total revenues of
$53 billion.
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DIRECT ACCESS TESTING IS ON THE RISE
The demand for direct access testing is expected to grow based on several factors:
1. efforts to improve the quality of health care are relying on the appropriate use of lab testing for early detection of
disease and patient management that is safer, more effective, more efficient and cost-effective.
2. An aging population and corresponding increase in the prevalence of chronic diseases are accelerating the use of lab
tests to screen, diagnose and manage patients. Medicare enrollees will reach 89 million by 2050. Population growth
contributes to this number.
3. The Human Genome Project has allowed for a larger number of genetic tests and provides better information for
targeted treatment to reduce adverse drug reactions.
4. Technological innovations and improved laboratory instrumentation make direct access testing more accurate and
easier to obtain.
5. There is a link between certain biomarkers and patient outcomes leading physicians to use this information to better
guide treatment decisions.
6. The increasing amount of health information, media attention to health care issues, and direct-to-consumer
advertising of new tests have all enhanced consumer awareness of and interest in lab testing.
To better manage and treat disease more providers and labs have taken steps to develop web based portals. Accessing
medical information online so that test results can be retrieved quickly is expected to make health care more effective and
proactive.
The health care industry is increasingly using lab data as an objective, scientific indicator of performance and outcomes.
One example of this is the helpfulness of lab test data in measuring outcomes for type 2 diabetes, which depends on the
association between test results (biomarkers) and patients’ long term health. Screening for type 2 diabetes with a fasting
plasma glucose test and/or oral glucose tolerance test can detect the disease in its preclinical phase. During the 10 to 15
years after clinical diagnosis, tight glycemic control can improve patient outcomes by reducing the risk of blindness and end
stage renal failure. In 2006, failure to test regularly accounted for 7,100 to 15,900 avoidable diabetes-related deaths and $1.3
to 1.7 billion in avoidable hospital costs.
There is little published research on the cost-effectiveness of lab testing, but as payers face increasing scrutiny of their
decisions about coverage of new testing technologies, the economic impact of lab testing on the health care system is
generating greater interest in cost-effectiveness analysis.
The convergence of multiple factors including the rising cost of health care, the growing number of uninsured and
underinsured people (which may change with the ACA), the aging population and the greater prevalence of chronic disease
is severely challenging the health care system. Laboratory medicine will play a more prominent role in repairing the health
care system as stakeholders increasingly demand scientific evidence for clinical decision making and strategies to address the
significant shortfalls in quality, outcomes and cost.
To learn more about the trends in laboratory testing, call 1-800-384-4567 or email us at [email protected] to schedule an appointment with one of our franchise sales professionals.
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BIBLIOGRAPHY
1Astion, Mike. “The Google factor.” Clinical Laboratory News 40.1 (2014): n. pag. AACC. American Association for Clinical
Chemistry, Jan. 2014. Web. June 2014.
2“Where Lab Tests Are Performed”. American Association for Clinical Chemistry, 1 Oct. 2012. Web. 24 June 2014. http://
labtestsonline.org/lab/labtypes/start/6.
3“Diagnostic & Medical Laboratories in the uS: Market research report”. IBISWorld. April 2014. Web. http://www.ibisworld.
com/industry/default.aspx?indid=1575
4Michel, robert L. “Healthcare’s Transformational Journey: Laboratory Medicine in the Year 2020.” National Lab
Training Conference V. Orlando, fL. June 2009. Web. www.aphl.org/conferences/proceedings/documents/2009/2009_
NLTCV/020Michel.pdf.
5The Lewin Group. “under the Microscope: Trends in Laboratory Medicine.” California HealthCare foundation. Ihealthreports.
April 2009. Web. http://www.chcf.org/~/media/MeDIA%20LIBrArY%20files/PDf/L/PDf%20LabDataTrends.pdf