In medicine, rapid diagnosis takes priority because treatment cannot be initiated without it. Patients in emergency departments, intensive care units (ICUs) and operating rooms (ORs) can decompensate rapidly or even die during the period of time it takes for traditional diagnostic testing. The last quarter of the 20th century has seen dramatic advancements in imaging, but laboratory testing has not seen similar improvements. The limitations in diagnostics for critical diseases have had a profound effect on the utilization of advanced therapeutics. Revolutionary therapies, such as clot-busting drugs and endovascular procedures for diseases, such as heart attack and stroke, are not widely utilized, even in patients who might benefit, because rapid diagnostics have not previously existed. In the time it takes for a patient to undergo magnetic resonance imaging (MRI) or computerized tomography (CT) and the results interpreted by trained medical specialists, valuable minutes—minutes that might separate therapeutic efficacy from absent benefit—can be lost. Biosite believes that clinical outcomes can be improved and healthcare costs lowered through more widespread use of innovative therapeutics, made possible by a rapid, accurate diagnosis.

While the potential benefit from improved rapid diagnostics has been evident to many in the healthcare industry, a powerful and reliable discovery pathway for proteomics has been elusive. The standard industry model has been watchfully waiting, followed by the in-licensing of already developed single-biomarker tests; this is a model that Biosite views as secondary. Instead, the priority is to proactively identify important diseases that are inadequately served by existing technologies, and pursue the discovery of biomarkers independently and through collaborations. Research programs that combine in-house biomarker development with clinical trials at leading research hospitals are the hallmark of Biosite’s approach, and hold the promise of identifying rapid diagnostic tests where previously nothing existed.

In medical diagnosis, test sensitivity relates to the ability to define a disease when it is present and specificity relates to the ability to confirm when a disease is absent. Biosite’s objective is to discover biomarkers that contribute clinically significant improvements to a physician’s ability to separate diseased from non-diseased populations. The company’s philosophy on diagnostic testing is simple: if a patient with a life threatening condition can be diagnosed more promptly, then the patient can be treated earlier in the disease process, improving the chances of a better outcome.This is why the company targets critical diseases that threaten patients emergently, and in areas where there are a lack of rapid and reliable diagnostics.These are the circumstances in which accuracy and timeliness in diagnosis hold the greatest promise.

The biochemistry of bodily fluids, such as blood orplasma, change as a disease progresses. In mostdiseases, tissue damage and biological responsemechanisms change the blood levels of analytes,enabling them to be potentially utilized as markers ofthe disease. Analytes that have modified bloodconcentration, over time, typically also reflect diseaseseverity. Recent advances in the understanding ofhuman biomarkers, including proteins, peptides,enzymes, hormones and other blood-bornemolecules have been the catalyst for Biosite'sdiscovery effort. Biosite Discovery”the company's unfair advantage'”is a uniquely powerful internalresearch program that utilizes state-of-the-artantibody development technology and focuses onscreening potential biomarkers. The company'sdiscovery programs are capable of screening manypotential targets in the process of identifying novel proteins that can function as disease markers'. Preexistingcollaborations with clinical thought leadersallows for the rapid evaluation of potential tests.