• Abaxis (Union City, California), manufacturer of point-of-care (POC) blood analysis systems, reported that the FDA has granted waived status under CLIA regulations for six additional analytes — Albumin, Alkaline Phosphatas, Amylase, Gamma Glutamyltransferase, Total Bilirubin and Total Protein — when used in conjunction with its Piccolo POC analyzer. The company said it now has 12 analytes that have received the CLIA waived status. The system consists of a compact, 6.9 kilogram, portable analyzer and a series of 8-cm diameter single-use plastic reagent discs that contain all the reagents necessary to perform a fixed menu of tests. Abaxis manufactures portable blood analysis systems for use in patient-care settings.

• Luminex (Austin, Texas), a provider of multiplex technologies for bio-assays, reported the launch of the Luminex Certified Developer Program. The Certified Developer Program brings together a community of licensed assay developers on Luminex's industry leading xMAP platform. Membership in the program provides benefits such as access to advanced technical training, co-branding opportunities and website exposure to the selected developers. Luminex development partners must meet stringent quality standards and have extensive experience and a record of success developing assays for xMAP technology in order to gain the status, Luminex said.

• MedMira (Halifax, Nova Scotia), a developer of rapid diagnostic solutions, reported receiving FDA approval for its Reveal G3 Rapid HIV-1 Antibody Test (Reveal G3), which delivers test results in less than three minutes. This is the third generation in the Reveal line of rapid HIV tests. Reveal G3 includes the addition of MedMira's InstantGold Cap which replaces the colorimetric detection agent used to visualize results on the test cartridge. This advancement eliminates the need for reconstitution and refrigeration of the colorimetric detection agent, improving the product's overall ease-of-use.

• Non-Invasive Monitoring Systems (NIMS; North Bay Village, Florida) reported that the U.S. Patent and Trademark Office issued Patent No. 7,111,346 on Sept. 26, titled, "Reciprocating movement platform for the external addition of pulses of the fluid channels of a subject." CEO Gary MacLeod said, "This third patent (first issued as US patent 6,155,976 in 2000 and second issued as 7,090,648 in 2006) encompasses 64 claims that further protects the value of the Company's flagship product (AT-101) for therapeutic and diagnostic applications that have already been published in peer-reviewed research studies as well as for future products and applications." He further announced that the company has developed the ‘Exer-Rest,' a lower cost, version of the AT-101 for utilization in the home environment." The AT-101 is not currently being sold in the U.S. pending FDA approval. A clinical trial is planned for its intended use of temporary relief of musculoskeletal pain associated with osteoarthritis of the hips.

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