There has been rapid innovation both in the range and complexity of diagnostic tests, and in
laboratory test methods and techniques. Advances in diagnostic products make it possible to
detect diseases early, when they often can be best treated. Advances in laboratory medicine have
also made lab tests easier to use and less subject to user error, they have led to more precise and
timelier results, and they have helped transform medical practice. Key trends in diagnostic test
innovation include: detecting disease before symptoms appear; predicting beneficial and adverse
treatment effects; enabling personalized treatment regimens; facilitating point-of-care testing;
and enabling home testing.

Technological advances are changing not only the way diagnostic tests are performed, but also
the practice of medicine itself. Improvements in diagnostic tests and the methods to perform
them provide increasingly more precise and timely information to assist medical caregivers to
prevent and diagnose disease, monitor its progression, and guide therapeutic options. Laboratory
innovations have resulted in many new tests that are more efficient and automated, and less
subject to user error. In addition, many tests have become less invasive or easier to administer,
causing less discomfort to patients.

A major driver for the growth and expansion of waived testing is the growth of Point- of-
care testing.

Tests are no longer confined to the laboratory. Point-of-care tests can now provide needed
information close to where health care is delivered, facilitating more rapid diagnoses and
treatment decisions and improved patient compliance with physicians’ recommendations.

Technological innovations have led to point-of-care tests that are available for use close to where
diagnostic and treatment decisions are made—at the patient’s bedside, in the emergency room or
clinic, at the workplace, in an exam room of a physician’s office, and even at home. Point-of-care
tests eliminate the need for trips to and from the central laboratory (and specimen collection sites
that are run by laboratories). These tests enable physicians to make more rapid diagnoses and
treatment decisions, and they improve patient compliance with physicians’ recommendations.
The demand for point-of-care tests has spurred the development of smaller, faster, and easier to
use tests that are more sophisticated in design than tests traditionally found in laboratories.
Having this information available near the patient permits the physician to begin necessary
treatment more quickly.

While less than 10 percent of lab tests are performed in a physician office lab, these tests can
provide immediate feedback to the clinician, offering the opportunity to address health care
problems while the patient is still in the office. Some of the tests performed in the office include
streptococcus testing, HIV (AIDS) testing, INR (coagulation) testing for coumadin and pregnancy
testing. There are waived test methodologies for all of these. The ability to immediately treat the
patient, without having to send a sample to a central hospital laboratory, can be critical to the
patient’s well-being. As an example, a positive test for strep can allow the clinician to
immediately prescribe antibiotics, catching an infection before it becomes severe, with potential
health consequences (or ruling out strep and avoiding unnecessary use of antibiotics).

Garnering information with a point-of-care test often allows immediate treatment, which avoids
requiring the patient to make multiple trips to the physician office and pharmacy, saving time for
both the patient and the clinician. Accurate diagnostic information at the point-of-care saves
critical medical resources and improves both patient and clinician satisfaction. In light of the role
of waived testing in the healthcare delivery system and overall benefits of these technologies,
availability of and timely access to these technologies will continue to be important to meet the
needs of patients and clinicians for rapid and reliable testing.

International Innovation Impact of Point-of-care testing and Waived Testing Technology

Site Laboratories:
Technology has allowed the development of smaller, limited menu laboratories that can perform
diagnostic testing. These smaller site laboratories are key to improving global laboratory capacity,
especially in countries with poor transportation infrastructure. These laboratories have the
responsibility for sample collection, initial processing if required, and storage and shipment of
specimens to larger central or reference laboratories. The quality of the laboratory test result is
only as good as the quality of the specimen, and this is controlled by the site lab. In addition,
important POC/ waived testing is often performed, such as rapid HIV, pregnancy tests,
hemoglobin levels, etc., and it is designed for regions where full laboratory services are not
available. In these areas, tracking diseases that can be diagnosed through multiple/alternative test
methods are particularly relevant to this approach.