Originally
Published IVD Technology May 2003
EDITOR'S PAGE
Dealing with epidemics
In recent weeks, the global outbreak of severe acute respiratory syndrome (SARS) has brought about quarantines and travel advisories throughout the world. Responding to the outbreak, medical researchers have rapidly mobilized to begin the work of developing diagnostics, therapeutics, and vaccines for the disease (see News, page 12).
The SARS outbreak is unique in many ways. There is virtually no previous instance in which a newly emerging illness has been recognized, its agent identified, and initial tests made available in such a short time. Such rapid turnaround is the result of a number of factors, including worldwide connectivity and the sharing of information via the Internet, heightened preparation for bioterrorism incidents, and biotechnological advancements in gene sequencing and other technologies related to molecular diagnostics.
For IVD manufacturers, epidemics such as the SARS outbreak present a number of challenges. One of the key issues is how to develop tests with sufficient specificity to permit rapid identification of infected persons. Public health authorities require such tests so that carriers of the disease can be quarantined without also isolating incorrectly diagnosed people.
Other challenges include the difficulty of gaining access to sample tissues and fluids from infected patients, especially during the initial stages of an epidemic when many researchers are clamoring for such access. In addition, manufacturers must be concerned about their ability to meet the regulatory requirements for a commercial product on a rapid timetable (though sometimes with useful cooperation from government agencies). And finally, there are the simple but important challenges of the time and cost required to develop a test.
Responding to outbreaks such as the SARS epidemic calls for IVD manufacturers to rapidly mobilize their resources—both individually and collectively. While it is difficult to prepare for the unknown and unexpected, IVD companies should ensure that they have the proper resources and processes in place to respond rapidly when needed. By doing so, IVD companies will not only be seizing a commercial opportunity, but also helping to quickly defeat global threats to public health.
Richard Park
Copyright ©2003 IVD Technology
