Japan’s Eisai and its diagnostic subsidiary, Sanko Junyaku, have launched the Lumipulse KL-6 and Lumipulse Presto KL-6 Eisai test kits, which detect KL-6, a marker of interstitial pneumonia. These diagnostic systems use automated chemiluminescence enzyme immunoassay system marketed by Fujirebio. In 2006, the three companies entered into an agreement to develop new KL-6 test kits.

A team of U.K. researchers at Imperial College London has developed a blood test that enables doctors to rule out tuberculosis (TB) infection in patients within a few days, rather than weeks. TB is difficult to diagnose because its symptoms include fever, fatigue and loss of appetite, which are associated with other conditions as well. The new blood test would prevent patients who do not have TB from being subjected to lengthy TB tests and patients with TB to undergo treatment earlier.

Vision-Sciences Inc. has received FDA approval for its 510(k) submission to market its advanced digital, video-based cystoscope line. The cystoscope line is meant to be used along with an integrated built-in light source, eliminating the need for a separate camera head, light guide cable and optical coupler. These lightweight videoscopes facilitate diagnostic and therapeutic procedures with the introduction of the world’s smallest diameter videoscope insertion tube containing a high resolution, miniature CCD (charge coupled device) camera at the tip of the insertion tube, offering a sharp, high definition, vibrant, full screen image.

The FDA has sent an NSE (non-substantially equivalent) letter to PreMD Inc. related to the 510(k) submission for an expanded regulatory claim on its point-of-care (POC) skin cholesterol test. “We continue to believe that this test fulfills a need for screening asymptomatic patients for risk of cardiovascular disease,” the company said. The FDA has rejected the claim citing concerns over the clinical utility of evaluating skin cholesterol with carotid wall intima thickness (CIMT) as the clinical endpoint.

Quidel Corporation has announced that the FDA has granted a CLIA (clinical laboratory improvement amendments) waiver for the QuickVue test. This test enables the qualitative detection of the respiratory syncytial virus (RSV). The American Academy of Pediatrics has recognized RSV as the primary cause of pneumonia and bronchiolitis in children of 2 years of age and below. The waiver allows the QuickVue RSV test to be made more widely available for use, especially in clinics and offices of physicians, where waived tests are used most frequently.