Archive for the 'Diagnostics products' Category

Aerocrine suit to protect its Nitric Oxide analyzer patent

Aerocrine logoAerocrine AB has filed a patent infringement suit against Medisoft P.A.E. associated with the marketing and sale of Nitric Oxide (NO) analyser in Germany. Aerocrine AB is seeking an injunction and damages against the Belgian company. Medisoft P.A.E. has recently begun the marketing and sale of the Hypair exhaled NO analyzer in the country.

Patent issued for Abviva breast cancer test

Abviva Inc. (formerly known as Genesis Bioventures) has been issued a pivotal patent by the United States Patent and Trademark Office for the core technology used in the company’s breast cancer diagnostic test. The Mammastatin Serum Assay (MSA) is a blood test used for the early detection of breast cancer through the identification and measurement of the amount of Mammastatin in women.

Urodynamix commences evaluation of NIRS DRE system

Urodynamix logoUrodynamix Technologies Ltd. has begun the evaluation of its second generation prototype near infrared spectroscopy (NIRS) DRE system. Digital rectal examination (DRE) is the most common screening test for prostate cancer and Urodynamix’s NIRS sensor measures blood flow in the prostate gland during the examination. The device improves physicians’ ability to detect prostate cancer as well as other prostate-related diseases.

FDA clears CellSearch test for metastatic prostate cancer

CellSearch System from VeridexVeridex LLC has received FDA clearance to market the CellSearch(TM) Circulating Tumor Cell (CTC) Kit as an aid to monitoring patients suffering from metastatic prostate cancer. The CellSearch System had already been cleared for metastatic breast and metastatic colorectal cancer and counts CTCs in a patient’s blood sample to predict progression-free and overall survival. The CellSearch CTC Kit was developed by Immunicon Corporation and is exclusively marketed by Veridex.

FDA clears new test to detect kidney disease

Diazyme logoDiazyme Laboratories has received a 510(k) clearance from the FDA to market its Cystatin C Assay Kit for verifying Cystatin C in serum and plasma samples for the early detection of chronic kidney disease. The Cystatin assay is highly accurate and precise and offers an extended reportable range of 0.47 to over 8 mg/L, reducing the need for repeating tests on elevated samples.

Siemens receives FDA nod for Versant 440

Versant 440 molecular systemSiemens AG has received FDA approval for its Versant 440 Molecular System for testing patients’ blood for the Hepatitis C virus. Versant 440 Molecular System, which represents the next generation in automated viral load testing, would be used with the Versant HCV RNA 3.0 assay for the management of patients infected with HCV and undergoing antiviral therapy. Versant 440 has already been approved in Europe, Africa and certain parts of Asia.

New catheter design promises improved dialysis procedure

The worldwide rights to a new catheter designed by Stephen R. Ash, MD, FACP, have recently been acquired by AngioDynamics.  Dr. Ash is well known for his invention of the original split tip dialysis catheter.

His newest invention, a self-centering, tunneled hemodialysis access catheter, is called Centros, and it boasts a unique curved configuration allowing it to keep the posts away from the vein walls.  The result is an uncompromised blood flow for longer periods of time, making the dialysis process easier for both the patient and doctors. Other benefits include fewer complications and shorter procedure times.

Roche acquires Ventana Medical Systems at $89.50 per share

Roche logoGlobal healthcare provider Roche acquired Ventana Medical Systems in a merger on January 22. Both companies’ boards approved the merger agreement, which included a premium of 4.9% to Ventana’s shareholders. Ventana employees will also be able to continue working for the company at the existing location in Arizona.

Roche expects to gain growth in companion diagnostics as well as advanced and primary staining from its acquisition. It is currently the world’s biggest biotech company, and global leader of in-vitro diagnostics, cancer pharmaceuticals and transplantation, and virology.

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