The Search for a Solution There are several ways in which a new test may be developed. One way is through evolving clinical use. A test may have been developed for one purpose, but over time, a new use for the test becomes apparent. This is how the
high-sensitivity C-reactive protein (hs-CRP) test has become increasingly used for predicting the risk of
heart disease. Its original purpose was to assess infection or inflammation associated with disease.
The most common way a test gets developed, however, is through the recognition of a need for an accurate test to detect a particular disease or condition. An example is the
test for b-natriuretic peptide (BNP). After years of looking for a better way to diagnose heart failure, it was realized that the hormone BNP is released into the bloodstream in response to heart failure and that the concentration of the protein varies with severity. Now, this test is gaining acceptance in hospitals as a test for this condition.
Increasingly, the technology required to bring new tests to market involves the combined research and financial resources of private industry, such as device manufacturers, laboratory companies, and academic laboratories. Like most businesses interested in developing new products, companies that develop new tests pay attention to where the need is greatest. Significant medical conditions that are widespread, such as cancer and
diabetes, are the focus of research and development because they affect many people and the clinical need is significant. However, tests for newly identified infectious agents are also very important.
The research and development of new products takes place in industry, university, and hospital laboratories. Today, partnerships and collaborations are increasing. An academic laboratory or start-up company might conduct the initial investigations into the identification of new disease markers, such as the presence of a molecular marker that may signal the likelihood of tumor development. Then, they might partner with a larger diagnostic company to complete development and perform the clinical trials. Today, many diagnostic companies have partnerships with academic laboratories and with smaller companies specializing in new emerging areas of technology or medicine.
Investments of time and money into a new test can take years before the benefits are finally realized. Test development can take anywhere from one to six years, depending on how complicated the test is. A number of ideas for tests never make it to the clinical trial stage, where the safety and efficacy are evaluated on patient volunteers, and sometimes a promising test that physicians read about in the scientific literature never becomes commercially available.
“Just because [investigators] can make it work in the research laboratory doesn’t mean they will make it work outside of it [in clinical practice],” said Robert Murray, PhD, technical director for Midwest Diagnostic Pathology at Lutheran General Hospital, Park Ridge, IL. “The tests don’t always come to market.”
