• Affymetrix (Santa Clara, California) launched GeneChip-compatible Applications Program, providing customers with a broad spectrum of software solutions for biomedical research and development integrated with the company’s GeneChip platform. Under the program, software developers are collaborating with Affymetrix to deliver software solutions that apply gene expression and genetic variation data to translational medicine, discovery research and systems biology. Nineteen software providers already have joined the program.
• Avitar (Canton, Massachusetts) said it has received a patent for its oral fluid collection device to be used for DNA polymerase chain reaction (PCR)-based testing. U.S. patent No. 6,926,678, titled “Sample Collection and Delivery Device,” covers a DNA collection device that Avitar said lends itself to be used in laboratories, hospitals, clinics, community-based and public health organizations, law enforcement agencies and diagnostic product OEMs. The company said that while blood testing is the method universally used for DNA testing and disease diagnostics, research has shown that oral fluids contain biomarker signature patterns that can track DNA and point to predispositions to diseases. Pete Phildius, chairman and CEO, said, “On-site oral fluid testing is emerging as a lower-cost, more-convenient alternative to traditional laboratory blood or urine testing for in vitro diagnostics applications.” He said the company’s preliminary research “has shown that 80% to 85% of all current laboratory-based, in vitro diagnostic tests could be performed more efficiently using oral fluid screens.” Avitar is a leader in oral fluid-based tests for drugs of abuse and HIV.
• Beckman Coulter (Fullerton, California) has launched its Integrated Cytometry Solution (ICS), which combines the company’s FC 500 flow cytometer with the new FP 1000 sample processing system. The company said the new solution, now being shipped to its customers, is the first integrated system to offer laboratory information system (LIS) connectivity. Suited for high-volume clinical reference laboratories, ICS streamlines workflow and tracks samples throughout the testing process, Beckman Coulter said, from receipt and preparation, to acquisition and analysis of data, to reporting results. It said that approach helps laboratories standardize their flow cytometry testing processes, resulting in an increase in efficiency, accuracy and operator safety. The company said flow cytometry is widely used to provide automated analysis of various blood cell populations. It is commonly used in in vitro diagnostics to identify and enumerate certain cell populations that are key indicators of diseases, including HIV, leukemia and lymphoma.
• Cytyc (Marlborough, Massachusetts) said the FDA has approved a premarket approval supplement for the ThinPrep Pap Test related to the detection of endocervical and endometrial glandular lesions. The enhanced labeling cites multiple peer-reviewed publications that report on the improved ability of the ThinPrep System to detect glandular disease vs. the conventional Pap smear. The labeling further states that the results of these studies are consistent in showing more frequent biopsy confirmation of abnormal glandular findings by ThinPrep technology compared to conventional cytology. The ThinPrep Pap Test is the only cervical cancer screening technology to gain expanded labeling claims related to the detection of glandular abnormalities. According to the company, the test is currently the most widely used method for cervical cancer screening in the U.S. and also is the only liquid-based cytology approved by the FDA for HPV testing and the only cytology system approved by the FDA for chlamydia and gonorrhea testing directly from the ThinPrep collection vial.
• Given Imaging (Yokneam, Israel) has introduced Rapid 4, which it said is the most advanced version of its Rapid software for use with the PillCam Platform. The company said Rapid 4 offers new physician-friendly features and diagnostic tools making it easier to read and interpret the videos captured from the PillCam SB and PillCam ESO video capsules. The new features include QuickView, which allows the physician to perform a fast, sequential and intelligent preview of suspicious images when present in the video stream as well as their location in the video prior to performing a full reading; Rapid Atlas, which allows the physician to quickly compare the on-screen video image with known small bowel and esophageal reference images stored in the database; Automatic Viewing Mode, which provides an aid for more efficient diagnostic review through a smoother image transition, making review of a video more comfortable for the reader; and Circumference Scale, a tool to help estimate circumferential involvement of a finding detected by PillCam ESO or PillCam SB such as an esophageal varix or a small-bowel ulcer. Rapid 4 has not yet been cleared for sale in the U.S.
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.
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.