Eisai, Sanko Junyaku launch pneumonia test kits

Sanko Junyaku LogoJapan’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.

Quidel receives CLIA waiver for QuickVue RSV test

QuickVue RSVQuidel 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.