Qiagen has won the US Food and Drug Administration (FDA) approval for its new molecular companion diagnostic product, therascreen KRAS RGQ PCR test kit, to provide guidance on the use of Erbitux for approximately 110,000 US patients with ...
Tags: Qiagen, FDA, molecular companion diagnostic product, test kit
The US Patent and Trademark Office (USPTO) has granted a patent for the use of Aeterna Zentaris' oral ghrelin agonist, AEZS-130 (EP1572) as a diagnostic test for adult growth hormone deficiency (AGHD). AEZS-130, which has been granted ...
Tags: AEZS-130, growth hormone deficiency, AGHD
Chronix Biomedical has opened a fully operational sequencing laboratory in Brookings, South Dakota, US, to expand its commercial capabilities. Chronix has opened the laboratory in association with the First Bank & Trust of Brookings, ...
The US Food and Drug Administration (FDA) has approved the use of Associates of Cape Cod's rapid diagnostic test in detecting invasive fungal infections (IFI). Using patient's blood serum, the Fungitell assay detects (1,3)-b-D-glucan ...
Tags: detecting invasive fungal infections, fungal pathogens, IFI
Enzo Biochem, a molecular diagnostics company, has introduced the ColonSentry blood-based risk stratification test to assess a patient's risk of having colorectal cancer. ColonSentry requires a small blood sample and utilizes RNA to ...
Tags: Enzo Biochem, ColonSentry blood-based risk stratification test
Neurotrack has introduced a new computer-based recognition memory test to diagnose Alzheimer's disease years before clinical symptoms appear. The launch was based on the results from a 5-year longitudinal study, funded by the NIH, which ...
Tags: Neurotrack, computer-based recognition memory test, Alzheimer's disease
Saladax Biomedical has signed a diagnostic agreement with Eilaf Pharma for My5-FU diagnostic test in Egypt and throughout the Middle East North African (MENA) region. The test will measure the levels of an anti-cancer drug, ...
Tags: My5-FU diagnostic test, medical research, medical test
The FDA has granted approval for Great Basin's first molecular diagnostic test for Clostridium difficile (C. diff). The integrated cartridge system comprises necessary reagents to perform the assay and predict the presence of ...
Tags: molecular diagnostic test, clinical product, clinical research
Genisphere and the Lankenau Institute for Medical Research (LIMR) will continue their colloboration on microRNA (miRNA) biomarker development for Ulcerative Colitis (UC) and will expand the partnership to include Crohn's Disease and other ...
US-based Trovagene has developed a urine-based molecular diagnostic test to detect and monitor cancer mutations. The test quantitatively detects KRAS mutations in transrenal DNA,which may be originated from both normal and diseased cells. ...
Tags: Trovagene, molecular diagnostic test, cancer mutations, cancer monitoring
Galapagos has identified new class of antibiotics targeting drug resistant Staphylococcus aureus (MRSA) strains and commenced clinical development of first antibiotic. The selected candidate, CAM-1, was effective against all tested MRSA ...
Tags: antibiotics targeting drug, MRSA
CML HealthCare, a provider of medical diagnostic services, has introduced a new blood-based diagnostic test for colorectal cancer. The new COLOGIC test is designed for screening patients who are at high risk for colorectal cancer and ...
Tags: medical diagnostic services, blood-based diagnostic test, COLOGIC test
Nicox has announced the US launch of its rapid point-of-care diagnostic test, designed for the detection of acute conjunctivitis. The FDA-cleared and CLIA-waived assay, AdenoPlus, uses its four-step process to detect adenovirus and ...
Tags: rapid point-of-care diagnostic test, FDA, medical devices
Amplion Research has launched BiomarkerBase, the first available database of every biomarker currently in active clinical use. BiomarkerBase is an easy to use data container and provides quick access to the detailed information available ...
Tags: Amplion, BiomarkerBase, clinical use, data container
Alfa Wassermann Diagnostic Technologies has unveiled its ACE Axcel Clinical Chemistry system, designed for use in physician office labs to process up to 285 tests per hour with both photometric and potentiometric detection technologies. ...
Tags: ACE Axcel Clinical Chemistry system, ACE Axcel system, Medical devices