The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has renewed the marketing authorization for Zila, Inc.’s OraTest® for an indefinite period. This allows the company to sell its proprietary diagnostic kit for oral cancer in seven European countries with a combined population of 100 million. OraTest is indicated as an add-on to visual examination for patients having high risk of high-grade malignant lesions. It can also be used to screen patients who have received treatment for oral squamous cell carcinoma. The kit has pharmaceutical grade tolonium chloride rinse product which is patented with Zila.

Scientists from Finland and Sweden have developed an innovative tool to identify parasites through the use of virtual microscopy online. The web-based diagnostic will be able to detect diseases caused by parasites such as malaria and amebiasis. The researchers believe that this method has the potential to improve the standards of diagnostics related to parasite-related diseases in low income countries. Karolinska Institutet (Sweden) and the Universities of Helsinki, Tampere, and Léon.

SiDMAP, LLC, has expanded its SiDTox™ services to enable rapid and specific detection of drug-induced organ toxicity. Using its proprietary metabolomics technology platform, SiDMAP is able to monitor changes in vital metabolite fluxes in response to drug treatment to quickly determine organ toxicity before structural or morphological damage occurs. On the basis of a research performed by SiDMAP along with the Center for Metabolomics at the FDA National Center for Toxicological Research, SiDTox™ will now include an affordable and non-invasive test that will allow researchers to detect drug-induced toxicity before organ damage.

InfraScan has  received the European marketing clearance (CE mark), for its handheld brain hematoma detector. This approval certifies that Infrascanner has met all the safety, health and environmental standards set up by European Union (EU). The diagnostic device is the first of its kind used for identification of fatal brain hematomas, thereby facilitating treatment critical to the recovery of patients. A portable device, Infrascanner is now pursuing applications for monitoring stroke victims with the use of the same technology.

The U.S. Food and Drug Administration has given approval to Chembio Diagnostics, Inc. to extend the age range for its HIV rapid point-of-care testing by lowering the age limit to 13 years and above from 18 years. The Laboratory of Viral Diagnostics, University of Maryland School of Medicine, conducted a clinical study and recommended the expansion of age limit on the basis of the study’s findings. The test can be carried out in primary care settings.

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.

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.

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.