In vitrodiagnostics is used to acquire clinically relevant information from biological samples such as blood, urine or tissue by testing the presence and/or quantity of a substance associated with a particular disease or therapeutic state. In traditional in vitro diagnostic tests, the substances can be cells, proteins and chemicals. A newer category of in vitro diagnosis, nucleic acid testing, detects the presence of a particular sequence of DNA in a specific gene or RNA transcripts, and can therefore be used to screen for the presence of genetic associated diseases, cancers or disease predisposition. Nucleic acid testing is also a powerful tool for detecting pathogens such as bacteria and viruses.

The in vitro diagnostic field offers tremendous market opportunities for successful innovations. The global market for in vitro diagnostic products is estimated to be over $20 billion in 2000 with an annual growth rate of 5%. The rapidly expanding global market for nucleic acid testing was estimated to be about $700 million in 2000, and is expected to exceed $1.2 billion by 2005 with an annual growth rate of 14%. As one simple example, the fields of prenatal testing, disease predisposition and cancer screening alone are expected to generate over $750 million in 2005. Additionally, genetic predisposition screening for blood coagulation disorders is increasing at a rate of 150% per year. Most analysts agree that, as a whole, these markets are largely untapped and have significant potential.

Current in vitro diagnosis heavily relies on intensive sample handling and liquid dispensing technology. Once a doctor prescribes in vitro diagnostic tests, a healthcare professional collects the patient's samples, labels them for the proper tests, sorts and then sends the samples to appropriate centralized clinical test labs, often via courier. At central testing labs, technicians sort and route the samples to the appropriate department such as clinical chemistry, hematology, microbiology, and immunology based on the assay required. Frequently, technicians conduct tests manually, or perform sample pretreatments such as centrifugation and other laborious sample manipulations before loading the samples into an automated test system. In these systems, liquid samples are transferred from sample tubes to reaction containers such as 96 well plates or test cartridges, and reagents are dispensed as programmed. To meet the requirements of high sample throughput on multiple assays, the equipment has become increasingly large and sophisticated. Overall, the entire sample handling process introduces many costs and delays to diagnostics, and frequently reduces sample quality. Furthermore, such complex handling greatly increases the probability of introducing errors to the results.

IQuum's lab-in-a-tube platform provides a unique solution. IQuum's Liat™ systems simplify sample handling, improve sample control, and completely integrate sample testing from sample collection through analysis for multiple assays on location. The Liat™ Analyzer is developed for nucleic acid based testing and the Liat™ Tubes serve both as collection devices and as test chambers, maintaining samples in a closed system from sample collection through sample disposal. We believe that the Liat™ system is suitable for a wide range of testing labs and near-patient test settings due to its ease of use, fast turnaround time, cost effectiveness and safety features.