TRENDS & PERSPECTIVES

In 2007, IVD industry leaders gathered for a one-day workshop hosted by Cambridge Consultants. The meeting produced the report “The Future of Diagnostics: A Consumer-Driven World?” and projected major growth in consumer-focused IVD products in the next 5–10 years. The attending delegates predicted that as technology improves and tests become less complex, IVD tests designed for home use or covered by Clinical Laboratory Improvement Amendments waiver regulations will increase.

According to the report, as the market focus shifts to include the consumer, the more successful IVD companies will likely offer a diagnostic assessment, clinical advice, and education. IVD manufacturers must also address rapid-test sensitivity and specificity, but not encourage self-diagnosis, which can lead to misinterpreted results and delayed treatment. A high occurrence of false-negative or false- positive results will discourage consumer compliance and increase manufacturers’ legal liability.

The delegates suggested three diagnostic test groups for future classification: behavior modification (tests that identify and treat curable diseases with a behavior or lifestyle change), disease management (tests that improve the quality of life for chronic disease sufferers), and genetic screening (tests that identify and treat potential inheritable diseases or disorders before symptoms appear). Although the test menu is expected to expand, IVD tests that require noninvasive (e.g., imaging, blood pressure) or minimally invasive (e.g., hair, urine) sampling or to target health conditions such as asthma, diabetes, and prostate cancer can expect early commercial success.

In addition, international travel and the Internet reduce the geo­graphic and regulatory limitations imposed on patients who wish to become more involved in monitoring their own well-being. FDA regulatory requirements for new technologies can involve a three to five year review period; however, India and the EU market provide a less restrictive testing ground for new IVD device technology.

Additional information about this workshop and the diagnostic industry report can be accessed at Cambridge Consultants’ Web site at www.cambridgeconsultants.com.