• Gen-Probe (San Diego) reported that the FDA has granted marketing clearance for its Aptima assay for Neisseria gonorrhoeae (GC), an amplified nucleic acid test that detects, on a standalone basis, the bacterium that causes one of the most common sexually transmitted diseases in the U.S. Gen-Probe said it is "the only company that can offer customers two nucleic acid tests that detect different parts of the GC genome." Gen-Probe's primary amplified STD test is the Aptima Combo 2 assay, which simultaneously detects Chlamydia trachomatis and GC. The Aptima GC assay was cleared to detect GC from a variety of sample types: clinician-collected endocervical, vaginal and urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens. The Aptima assays can be run on Gen-Probe's semi-automated direct tube sampling instruments.

• Meridian (Vancouver, British Columbia), a manufacturer of integrative diagnostic equipment, said the FDA approved its Lapex-2000 for use in treating Carpal Tunnel Syndrome. The Lapex-2000 uses low-level laser therapy, which delivers a laser light to various areas of the body without damaging the skin tissue. The light source is placed in contact with the skin allowing the photon energy to penetrate tissue. The body then coverts the photon energy into biochemical energy by interacting with cellular structures resulting in the restoration of normal cell function and enhancement of the body's natural healing process, according to Meridian. The Lapex-2000 is digitally controlled with an LCD screen and is easy to operate. The company said it believes its product can greatly reduce the need for medication and surgery, producing "a more active and less painful lifestyle."

• Milestone Scientific (Livingston, New Jersey), which makes computer-controlled local anesthetic delivery systems for medical and dental applications, reported the launch of its new Ionic White enhanced technology tooth whitening system to the consumer market via television infomercials that aired last week in 23 markets throughout the U.S. The Ionic White system whitens and brightens all tooth surfaces within about 21 minutes in a home kit that includes a "cool blue" intra-oral light and proprietary gel. Ionic White starter kits include a proprietary StayWhite whitening rinse, which allows users to continuously maintain white, bright smiles after the initial whitening process. The StayWhite rinse will also be sold as part of a continuity kit, providing Milestone with recurring revenues after the initial sale of each Ionic White system. Both products will be sold through a joint venture, and Milestone will receive a fee for each system and continuity kit that is purchased.

• Nanogen (San Diego), developer of advanced diagnostic products, reported that it was issued U.S. patent No. 6,864,071 by the U.S. Patent and Trademark Office. The patent relates to amplifying and analyzing multiple samples of nucleic acid using ligation-based strand displacement amplification (SDA) technologies. The intellectual property pertains to research Nanogen conducted in collaboration with Becton Dickinson (Franklin Lakes, New Jersey) and increases Nanogen's portfolio of technologies for multiplex amplification on a chip. The combination of SDA and Nanogen chip technologies makes it possible to conduct multiplex amplification, detection and analysis of multiple samples within a single electronic microarray. SDA is an isothermal amplification process that uses a series of primers, DNA polymerase and a restriction enzyme to exponentially amplify the target nucleic acid sequence.