Abbott Molecular (Des Plaines, Illinois) said a study published in the July issue of Journal of Urology has shown that UroVysion, a DNA-based urine test that detects important genetic changes in bladder cells, has almost twice the sensitivity of conventional urine cytology tests, the current gold standard, as an aid for the initial diagnosis of bladder cancer in patients with hematuria suspected of having bladder cancer. The prospective, blinded study involved 497 eligible patients with an average age of 63 from 23 clinical sites throughout the U.S. and Canada. All patients had confirmed hematuria within three months of enrollment. The results showed that UroVysion detected 69% of bladder tumors, while cytology detected 38%. When low-grade, low-stage tumors were excluded, UroVysion detected 83% of the cases, while cytology detected only 50%. The probability that negative UroVysion results were not associated with bladder cancer in this group was 98.5%.

Celera Genomics (Rockland, Maryland), an Applera business, reported that the RealTime HCV Genotype Assay has received the CE mark. The company said it is the first real-time test for genotyping the hepatitis C virus (HCV) to obtain regulatory approval for commercial sale in Europe, and is designed for use on the automated ABI PRISM 7000 real-time PCR (polymerase chain reaction) system from Applera's Applied Biosystems (Foster City, California) group. The test was developed, and will be sold, through Celera's alliance with Abbott Laboratories (Abbott Park, Illinois). The new Abbott RealTime HCV Genotype test automates key steps of the process, from PCR to data analysis and generation of a results report, allowing laboratories to process molecular tests efficiently and accurately.

Dade Behring (Deerfield, Illinois) reported that it has launched an automated Ecstasy test on its Dimension chemistry systems. The new test uses the Syva EMIT technology, which the company said is the most widely used and extensively validated in the drug testing industry. The Ecstasy test is now available on the Dimension chemistry systems and V-Twin, Viva-E and Viva-Jr drug testing systems. Separately, Dade Behring reported that it has launched the Quadriga BeFree infectious disease testing system to the non-U.S. marketplace. Quadriga is a fully automated, high-throughput system used to screen blood for common infectious diseases such as HIV and hepatitis. It will be used by large, mid- to high-volume blood bank laboratories to screen donated blood prior to it being used for a blood transfusion. Features of the Quadriga BeFree System include automated patient sample handling and verification, automated barcode identification of patient samples, and continuous monitoring of the instrument's status.

Sontra Medical (Franklin, Massachusetts) reported the completion of the first clinical study to verify the performance of its Continuous Transdermal Glucose Monitor (CTGM). Preliminary analysis of results demonstrated that the wireless glucose flux sensor accurately detected transdermal glucose to predict real-time changes in blood glucose levels for 24 hours. The primary goals of the study were to validate the design and operation of the wireless sensor and monitor system and collect data sets that will lead to the development of a blood glucose prediction algorithm. The Sontra CTGM is being developed to monitor blood glucose of patients in the hospital intensive care unit.