Diagnostics Product Guide

Yale doctors create a POC testing system

Jim Marino — Fri, 10 Oct 2008 14:59:48 +0000

Scientists at Yale Institute for Nanoscience and Quantum Electronics have developed nanowire sensors attached with simple microprocessor electronics which are both sensitive and specific enough to be used for point-of-care (POC) disease detection. When highly specific antigens activate immune cells, acid is produced. A current is generated in the nanowire electronics. This indicates that a specific antigen (viruses, bacteria or cancer cell) is present, allowing for detection. The system gives results really fast and is compatible with the currently available CMOS electronics.

FDA clearance to Tosoh G8

Jim Marino — Mon, 06 Oct 2008 07:40:49 +0000

The U.S. Food and Drug Administration has cleared the Tosoh G8 which offers pinpoint precision with the industry’s lowest CVs of less than 2%. The instrument-reagent system uses the gold standard ion-exchange method of HbA1c levels testing to monitor glycohemoglobin in diabetic patients effectively. The system’s automatic start-up and touch-screen operation make it very user-friendly. Also, it fits in most of the laboratory environments easily. The G8 is a diagnostic system for measurement of HbA1c in samples of blood.

VasSol’s NOVA™ now available in Eurpoe

Jim Marino — Fri, 03 Oct 2008 06:05:43 +0000

Designer and manufacturer of NOVA™ (Non-invasive Optimal Vessel Analysis), VasSol, Inc. has announced that the technology will now be available in European markets. The company entered into a partnership with Tekmed Instruments, its Italian distributor, during the last month. NOVA™ is a non-invasive tool for the measurement of blood flow. The Quantitative MRA software does not need a contrast solution to be injected. Nor is there a requirement to expose the patient to radiation. The technology has useful vascular applications.

Randox introduces novel array technology

Jim Marino — Mon, 29 Sep 2008 11:37:11 +0000

Randox Laboratories has come up with a biochip array for simultaneous quantitative diagnosis of three tumor markers in a single patient sample. This provides a quick, reliable and low-cost method for the screening of prostate cancer. The currently used PSA measurement is not a sufficient diagnostic tool in itself. The new technology from Randox is based on an ELISA format.

FDA approval to GE Healthcare’s AdreView™

Jim Marino — Thu, 25 Sep 2008 08:59:30 +0000

The U.S. Food and Drug Administration (FDA) has approved GE Healthcare’s molecular imaging agent AdreView™ (Iobenguane I 123 Injection) for the detection of rare neuroendocrine tumors in children and adults. The product provides images of high quality that assist physicians in the detection of tumors, at the initial stage as well as at the time when relapse is suspected. AdreView™ marks an advancement in diagnosis of cancer patients suffering from neuroblastoma. It will also identify primary and metastatic pheochromocytoma.

Jim Marino — Tue, 23 Sep 2008 12:30:57 +0000

Scientists will, now, be able to understand the movement of cells in the area around tumors (tumor microenvironment) in a better way. Researchers at University of California, San Francisco used optimized methods of laser microscopy to track the movement of live cells in a mouse model of breast cancer. Cancerous growth is supported by some normal cells while the immune cells protect the body against the tumor. The study aims to identify drug targets which can be withdrawn to prevent cancer and stimulate those that enhance the immunity of body towards the disease.

Syntermed introduces its new diagnostic tools

Jim Marino — Thu, 18 Sep 2008 08:36:31 +0000

Syntermed, Inc.’s SyncTool™, a diagnostic tool for heart failure, has been exclusively licensed by GE Healthcare for new Xeleris workstations in combination with Syntermed’s Emory Cardiac Toolbox™ (ECTb). GE is also offering the software as an upgrade to existing customers that examines the advantages of cardiac resynchronization therapy (GE Healthcare) in patients suffering with heart failure. This will make nuclear cardiology more efficient and accurate. Syntermed also introduced a range of novel solutions for nuclear cardiology, such as ReconTools™ that will enhance diagnostic capabilities, and Syntermed Live™ which advances imaging workflow.

Sequenom acquires rights to diagnostic intellectual property

Jim Marino — Wed, 17 Sep 2008 08:05:19 +0000

Sequenom Inc. has acquired exclusive worldwide rights (excluding Hong Kong) to digital PCR and other noninvasive prenatal diagnostic intellectual property from The Chinese University of Hong Kong. These rights expand Sequenom’s already existing, broad intellectual property portfolio of noninvasive prenatal diagnostic methods using fetal nucleic acids obtained from a maternal sample. The agreement expands Sequenom’s leadership position as it continues to advance its clinical development programs and marketing plans for its proprietary, noninvasive Trisomy 21 Down syndrome maternal blood test and other innovative prenatal diagnostic tests.

FDA clearance to MiCardia for marketing Dynaplasty™ Annuloplasty devices

Jim Marino — Thu, 11 Sep 2008 15:09:39 +0000

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to MiCardia Corporation for marketing its Dynaplasty™ Annuloplasty Band DR™ and Annuloplasty Ring DR. These are the company’s first Dynaplasty technology products to receive this clearance. Welcoming this approval MiCardia CEO, Paul Molloy commented that it involved extensive technical validation of the Company’s first generation annuloplasty system. He said, “It prepares the way for the progression of this highly unique and innovative Dynaplasty Technology and pairs with the commencement of the Company’s DYANA Phase I human study in Europe”.

Ranplex CRC advances bowel cancer detection technology

Jim Marino — Tue, 09 Sep 2008 14:24:06 +0000

Randox Laboratories Ltd has come up with RanplexCRC , a diagnostic test that can detect 28 polymorphisms associated with colorectal cancer in a single stool sample. It does not require a hospital visit or restrictions on diet. Moreover, the test shows greater sensitivity than the diagnosis process in use currently, the Faecal Occult Blood (FOB) screening test. By profiling the patients more accurately, the test will save time and resources. There will be lesser number of patients for colonoscopy, and the patients will be saved from discomfort.