BioView (Rehovot, Israel) said the FDA has granted U.S. marketing clearance for its automated scanning microscope and image analysis technology, the Duet System, for cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis' (Downer's Grove, Illinois) UroVysion Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p21 locus, from subjects with transitional cell carcinoma of the bladder. The Duet System is used in vitro as a diagnostic aid for the detection, classification and counting of pathological versus normal cells based on color, intensity, size, pattern and shape using BioView's advanced algorithms for classifying and counting cells of interest with both brightfield and fluorescent scanning. FDA clearance previously was given to BioView for hematopoietic cells stained by Giemsa stain, immunohistochemistry (with bright field and fluorescent) prepared from cell suspension and amniotic cells stained by FISH using direct-labeled DNA probes for chromosomes X, Y, 13, 18 and 21. BioView, a private company established in 2000, is developing cell imaging equipment, biological kits and software to medical institutes and universities for other cancer screening, cancer diagnostics and monitoring of minimal residual disease.
Merge eMed (Milwaukee), a Merge Healthcare company focused on accelerating productivity for radiology department and specialty practices, imaging centers and hospitals, reported the launch of a new eCommerce product, Baby Explorer, a 3-D fetal imaging software application. Baby Explorer, created by Cedara Software, also a Merge Healthcare company, is an ultrasound plug-in application for generating advanced 3-D fetal images. Running on a standard PC, Baby Explorer enables technicians to generate 3-D fetal images from 2-D clips. Used to ensure the proper growth of the fetus and to investigate potential abnormalities, Baby Explorer provides volume rendering that enables the anatomical features of the baby to be seen using simple controls. Baby Explorer supports multiple image types, and exports images that can be printed on standard printers or saved on CD-ROMs, giving users the ability to provide expectant parents with 3-D fetal pictures as a part of their ultrasound exam.
Olympus Diagostic Systems Group (Melville, New York) reported the availability of two new EMIT II Plus assays, Amphetamines (OSR9C229) and Ecstasy (OSR9X229). The company said the assays expand the drugs-of-abuse testing capabilities of the entire Olympus AU chemistry-immuno analyzer system platform, including the AU400/400e, AU600, AU640/640e, AU2700 and AU5400 analyzers. The EMIT II Plus Amphetamines and Ecstasy assays come in a liquid, ready-to-use format. Specific calibrator cutoffs are provided in accordance with proposed SAMHSA guidelines. The EMIT II Plus Amphetamines assay is intended for the analysis of amphetamines in human urine. The Ecstasy assay is intended for the analysis of methylenedioxymethamphetamine (MDMA) and closely related drugs MDEA and MDA in urine.
Quidel (San Diego) reported entering the rapid test market for determining the presence of blood in stool specimens as an aid in colorectal cancer screening. It has acquired the immunochemical Fecal Occult Blood Test (iFOBT) from Alfa Scientific Designs (Poway, California). The FDA-cleared and CLIA-waived test will be marketed to healthcare professionals as the QuickVue iFOB test. Quidel said the immunochemical fecal occult blood test category represents a large market opportunity, with more than 50 million fecal occult blood tests sold annually through medical/surgical distributors in the U.S. alone. It noted that Medicare reimbursement rates awarded immunochemical fecal occult blood tests over Guaiac-based fecal occult blood tests are significantly higher, since they have no dietary or medicinal restrictions and exhibit higher clinical sensitivity. The American Cancer Society recommends an annual fecal occult blood test for persons aged 50 and older to assist in the early detection of colorectal cancer.
Power3 Medical Products (The Woodlands, Texas), a proteomics company engaged in the discovery of protein footprints, pathways and mechanisms of diseases, said it has filed a provisional patent application with the U.S. Patent and Trademark Office for the company's blood-based Alzheimer's disease (AD)-specific diagnostic test. The patent application is being filed in conjunction with research institutions in the Houston area, with Power3 having an exclusive license to commercialize the technology involved. The application is in support of the company's planned third pre-IDE application to be filed with the FDA to seek their guidance on aspects of the approval process for the diagnostic tests being commercialized by the company. The test separates the proteins present in a patient's blood sample, analyzes a panel of protein biomarkers using proteomic techniques, and determines whether or not the patient has AD based on the quantity of the biomarkers in the patient's sample combined with biostatistical analysis. The company said it also intends to extend the technology to high-throughput immunodiagnostics suitable for clinical laboratories and physicians' offices.
Sepal Reproductive Devices (SRD; Sudbury, Massachusetts) said its new AmniSure test for rupture of fetal membranes (ROM) in pregnant women was featured in a clinical study in the July issue of the American Journal of Perinatology. The purpose of the study was to compare the AmniSure rapid immunoassay with standard methods for diagnosing rupture of fetal membranes. The AmniSure test demonstrated a sensitivity of 98.9%, specificity of 100%, positive predictive value of 100%, and a negative predictive value of 99.1%. AmniSure non-invasively detects placental alpha microglobulin-1 (PAMG-1), a protein that is abundant in amniotic fluid. SRD said AmniSure said semen, urine and vaginal infections not interfere with the efficacy of the test.
Tm Bioscience (Toronto) said that Genzyme Genetics, a provider of complex diagnostic testing services, has launched its upgraded CFplus cystic fibrosis mutation analysis, which now includes testing for 97 mutations. The CFplus assay incorporates technology from Tm Bioscience that was developed in a collaborative effort. "Our collaboration with Genzyme Genetics has produced one of the most innovative and technically advanced products available in the area of molecular diagnostics, made possible through our Tag-It platform," said Greg Hines, president and CEO of Tm Bioscience, a company whose product menu is focused on human genetic disorders, pharmacogenetics and infectious disease.