• Asuragen (Austin, Texas) reported the launch of its BCR/ABL1 Quant (RUO) kit, a research tool using multiplex real-time quantitative RT-PCR to provide simultaneous detection and quantification of BCR/ABL1 fusion transcripts (b2a2, b3a2, and e1a2), ABL1 (an endogenous control), and BCR/ABL1Quant Norm (an exogenous control) in a single reaction. The kit is based on TaqMan technology and is compatible with ABI 7500 real-time systems or equivalent. The BCR/ABL1 transcript arises from a specific chromosome translocation, known as the Philadelphia chromosome, and is the hallmark of chronic myeloid leukemia (CML). Fusion transcripts corresponding to BCR/ABL1 b2a2 or b3a2 are present in >95% of CML patients. BCR/ABL1 Quant is an assay providing broad target coverage and dynamic range with internal and external assay calibration powered by Asuragen's Armored RNA Quant technology. The kit includes an optional exogenous internal spike in ARQ control, BCR/ABL1 Quant Norm, to assess process efficiency and 4 external calibrators consisting of a blend of precisely quantified BCR/ABL1, ABL1 and BCR/ABL1 Quant Norm ARQs mixed at different concentrations to generate 3 standard curves.

• BD Diagnostics (Burlington, North Carolina) has received FDA pre-market approval for the BD FocalPoint GS Imaging System. This system is designed to enhance cervical cancer screening for cytology laboratories using the BD SurePath Pap test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions. The key to detecting cervical cancer early is regular Pap testing. However, limitations exist with current technologies. Approximately one-third of Pap smear false negatives can be attributed to screening and interpretive errors in which abnormal cells are incorrectly classified. BD says the FocalPoint system seeks to address this problem by offering laboratories key advantages over current cervical cancer imaging systems. Its guided screening technology helps rapidly relocate the fields of view that the system has identified as the most likely to contain cells of interest.

• Evalve (Menlo Park, California) said that long-term data published in EuroIntervention showed that the expected decrease in Mitral Vale Area (MVA) after repair with the MitraClip system to correct mitral regurgitation (MR) is not associated with clinically significant mitral stenosis. Additionally, with two years of follow-up, none of the patients treated with the MitraClip system required surgery for mitral stenosis. At 12 months no important differences were reported between the use of one or two MitraClip devices or based on the etiology of MR. The analysis was conducted to assess diastolic mitral valve function after percutaneous repair. Echocardiographic measurements of MVA and mean trans-Mitral Valve Gradient (MVG) were made in 96 patients implanted with the MitraClip device. The MitraClip system provides a non-surgical mitral valve repair option for patients suffering from the effects of MR. The device creates a double orifice mitral valve by securing the leaflets to reduce MR in a replication of the surgical procedure. The resulting double orifice has an inherently smaller cross sectional area compared to the native mitral valve.

A new study launched by researchers at Quinnipiac University (Hamden, Connecticut) will attempt to determine whether seniors monitored by Healthsense's (Mendota Heights, Minnesota) wireless sensor technology at the Masonicare healthcare and retirement community, are able to remain independent for longer, delay being admitted to a hospital or nursing home, and better attend to their own basic daily needs. Healthsense is an aging services technology company.

• IP2Biz (Atlanta) said a prototype wound measurement camera is being tested by wound specialty nurses at the Shepherd Center (also Atlanta). The hand-held device determines and captures wound boundaries and wound area using software and low-cost hardware. The company says the device provides fast, accurate and repeatable digital documentation of wound progression, a necessary component to validate payment from insurance and government agencies.