• American Bio Medica (Kinderhook, New York) said that the FDA has granted CLIA waived status to the company's Rapid TOX point-of-collection drug test product line. The waiver applies to all 14 drugs that the company currently tests for in addition to two different cut-off levels for its opiate and cocaine tests. CLIA-waived tests are the most widely used tests in the clinical market, including both hospitals and physicians, and are in demand for occupational health and criminal justice applications. American Bio Medica makes diagnostic test kits, including point-of-collection tests for drugs of abuse.

• Assay Designs (Ann Arbor, Michigan) reported the launch a new portfolio of thoroughly characterized ELISA development kits called ImmunoSet. This portfolio of products to assay proteins in various matrices contains the basic components and protocol for the development of five 96-well colorimetric enzyme immunoassays. Assay Designs said it has an aggressive plan for the development and release of the ImmunoSet products, beginning with kits for the detection of mouse and rat heme oxygenase-1 (HO-1) and p53/MDM2 complexes. "With this initial launch of unique antibody sets for our new ImmunoSet product line, Assay Designs is enabling customers with cost effective tools to improve the output of their research," said Dan Calvo, president/CEO. "We will continue to monitor the scientific literature, market trends, and our own antibody sales to expand this important product line as customer demand dictates." Assay Designs makes immunoassay kits, luminescent reagents, antibodies, proteins and extracts used for life sciences research.

• Carestream Health (Rochester, New York) reported the introduction of the Carestream DRX-1 system. Carestream said the system, which is in the final stages of development, is expected to greatly reduce the time required to conduct general X-ray exams compared to traditional film/screen systems. A standard patient X-ray exam with multiple images can be captured in less than one minute. The DRX-1 features wireless communications between the imaging components and a console that processes and displays the images and forwards the study to an image and information management system for review, reporting and storage. Carestream Health makes dental and medical imaging systems and healthcare IT solutions.

• Stanbio Laboratory (Boerne, Texas) has received clearance from the FDA for a new blood-testing device, the HemoPoint H2 n•x•t Microcuvette. The company said the microcuvette simplifies sample collection and virtually eliminates the possibility of air bubbles becoming trapped in the optical reading window. "This . . . design represents the first substantial improvement to the microcuvette in over 30 years," says William Pippin, president of Stanbio.

• Volcano (San Diego) reported the use of its VH IVUS in GlaxoSmithKline's IBIS-2 trial. In the study, Volcano's VH IVUS technology demonstrated and quantified compositional changes in atherosclerotic plaque that occurred over time. In IBIS-2, VH IVUS showed compositional changes in the placebo group that suggest continued progression of necrotic core despite standard of care therapy. Use of the novel Lp-PLA2 inhibitor, darapladib, plus standard-of-care therapy prevented this progression. VH IVUS is a catheter-based technology that creates colorized tissue maps of plaque composition in real time. The technology uses spectral analysis techniques to allow simplified interpretation of ultrasound images and provide detailed information on the composition of each patient's atherosclerotic plaques. The color VH images show four plaque component types: necrotic core, dense calcium, fibrous and fibro-fatty. Volcano makes IVUS products.