• Barr Pharmaceuticals (Montvale, New Jersey) reported the launch of AmniScreen, an at-home screening test for amniotic fluid leakage during pregnancy. AmniScreen is a prescription-only panty liner device that includes a proprietary polymer-coated polyester strip designed to detect amniotic fluid leakage, which could indicate a potential problem with a pregnancy. AmniScreen works by detecting elevated pH levels, which may indicate amniotic fluid leakage. The AmniScreen is intended to detect possible leakage of amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH level. pH levels greater than or equal to 5.2 produce a blue-green color. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care. Barr Pharmaceuticals is a specialty pharmaceutical company that operates in more than 30 countries worldwide.

• Cytori Therapeutics (San Diego) said that positive longer-term follow-up data were presented from an independent, investigator-sponsored breast reconstruction study in Japan. As part of the study, adipose tissue-derived stem and regenerative cells, processed with Cytori’s Celution 600 System, were used to reconstruct breast tissue following partial mastectomy. In the study, tissue loss resulting from partial mastectomy was reconstructed with each patient’s own liposuctioned fat, which was combined and enhanced with her own adipose-derived stem and regenerative cells. These cells were made available at the time of surgery using Cytori’s device, the Celution 600 System. Two clinical studies will be initiated this year in Europe by Cytori to further evaluate adipose-derived stem and regenerative cells, processed with the Celution™ 800 System, in breast reconstruction following partial mastectomy.

• Kensey Nash (Exton, Pennsylvania) said that it has received FDA clearance for an important vessel wall detection technology, designed to enhance the guidance provided by the Safe-Cross RF CTO system. The Safe-Cross system combines a forward-looking guidance system and radio frequency (RF) energy to safely cross and recanalize chronic total occlusions in the coronary and peripheral arteries. The clearance allows the company to incorporate a new interferometer with greater dynamic range into the Safe-Cross console, an important element of the System involved in vessel wall detection. The technology will allow the system to sense the vessel wall farther in advance. Earlier vessel wall detection should provide the physician operator with more options to redirect the wire while crossing a chronic total occlusion. Kensey Nash develops solutions and technologies for a range of medical procedures.

• Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) reported that Yale University (New Haven, Connecticut) has released the results of its Phase II study on a blood test to detect early stage ovarian cancer. Using six biomarkers, this blood test can discriminate between disease-free women and ovarian cancer patients (stage I-IV) with high specificity (99.4%) and sensitivity (95.3%). Initial studies are focused on women who have increased risk for the development of ovarian cancer. Ovarian cancer is the fifth leading cause of cancer-related deaths in women in the U.S. and is the leading cause of gynecologic cancer deaths. LabCorp specializes in developing diagnostic technologies.

• Sequenom (San Diego) reported a development of a non-invasive test for Trisomy 21, Down syndrome, that will incorporate multiple RNA fetal markers, including the PLAC4 gene. In preliminary studies, more than 100 clinical plasma specimens of various ethnicities were tested with partners using the company’s MassARRAY platform and its SEQureDx Technology. Data from the studies indicate that the development-stage Trisomy 21 test is approaching 85% ethnic coverage, more than 95% sensitivity and close to 99% specificity. The Trisomy 21 test is being developed to directly assess risk of Down syndrome using a maternal blood sample as early as the first trimester through the early second trimester, prior to invasive procedures such as amniocentesis or chorionic villus sampling that carry unnecessary risk to mother and fetus. The Trisomy 21 test is expected to be commercially available as a laboratory developed test (LDT) through licensing partners in the first half 2009. Sequenom makes genomic and genetic analysis products for research and the molecular diagnostic markets.

• Smiths Medical (St. Paul, Minnesota), part of the global technology business Smiths Group, said that it will distribute Life-Tech’s ContiStim stimulating catheter, an addition to their current line of peripheral nerve block products. Stimulating catheters have the ability to conduct current and stimulate motor nerves when used in conjunction with a nerve stimulator. Clinicians who prefer a stimulating catheter believe they obtain an increased nerve block success rate due to better catheter placement, resulting in improved patient outcomes and pain relief. ContiStim stimulating catheters feature an atraumatic ball tip that protects against tissue damage while providing a uniform 360 degree stimulus pattern, and they’re the only catheters that allow stimulation during placement as well as hours or days after the initial placement. The catheter’s “stingray” catheter connector has an integrated stimulus wire, an EzTwist closure that clicks to provide positive indication of secure catheter connection, and a flat profile that enhances patient comfort and freedom of movement. Smiths Medical is a supplier of specialist medical devices to global markets.