Ariosa Diagnostics, maker of the Harmony prenatal test, has announced the publication of two clinical studies involving twin pregnancies in Fetal Diagnosis and Therapy. The two studies provide information on how to consider use of ...
Tags: Ariosa Diagnostics, prenatal test
U.S. scientists say they have developed a urine test for hard-to-detect blood clots, which can cause strokes and heart attacks. Lead author and doctoral candidate Kevin Lin, postdoctoral fellow Gabriel Kwong and Sangeeta N. Bhatia, all at ...
The U.S. Food and Drug Administration halted the selling of the 23andMe Saliva Collection Kit and Personal Genome Service -- a home DNA test. In a letter posted on its website, the FDA alleged 23andMe was being sold without clearance or ...
Preliminary studies identified the presence of breast cancer cells from serum biomarkers indicating a blood test may be possible, U.S. researchers say. Study leader biomedical engineer Tony Hu of Houston Methodist Research Institute in ...
OrSense, a developer of solutions for non-invasive measurements of various blood parameters, announced that it has received the US Food and Drug Administration clearance for its NBM-200MP, noninvasive hemoglobin (Hb) and pulse oximetry ...
Tags: Orsense, FDA Clearance
The University of Michigan’s Department of Pathology MLabs has announced the commercial availability of Mi-prostate score (MiPS) test for men, a new urine test that measures minute fragments of RNA in prostate cancer. The test ...
Tags: Prostate Cancer, Medicine
Israel-based Given Imaging has secured regulatory clearance in Japan for its PillCam COLON, a video capsule that can help in the diagnosis of colonic disease in patients who are unable or unwilling to undergo colonoscopy. Given Imaging ...
Tags: Given Imaging, Capsule
LifeCodexx has revealed that its PrenaTest, a non-invasive molecular genetic blood test, can now be performed to determine high risk pregnancies even as early as the ninth week of pregnancy. Generally, PrenaTest is used to determine fetal ...
Tags: LifeCodexx, Pregnancy, Medicine
Saladax Biomedical, US-based developer of diagnostic tests that optimize a patient's exposure to chemotherapy, has been certified as a registered CLIA Laboratory from the Office of Clinical Standards and Quality (OCSQ), a division of The ...
Tags: Laboratory Certification, Saladax
France-based specialty diagnostic solutions provider Diaxonhit and XDx in the US, have entered into a memorandum of agreement (MoU) for the exclusive license to market and perform AlloMap Molecular Expression Testing (AlloMap) in Europe. ...
Tags: Diaxonhit Partners, Market Allomap
Inostics, a molecular diagnostics firm providing blood-based mutation testing, has received the Clinical Laboratory Improvement Amendments (CLIA) license for its clinical laboratory in Baltimore. The receipt of the license would mark a ...
Tags: Clia Certification, Medicine
Abbott has received CE Mark for its Architect clinical chemistry Hemoglobin A1c (HbA1c) test, which may assist physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes. The HbA1c ...
Epic Sciences, a developer of diagnostic tests, has received a Phase II small business innovation research (SBIR) contract from the National Cancer Institute (NCI) and the National Institutes of Health (NIH) for the development of a lung ...
Tags: lung cancer diagnostic, blood test, Epic
The National Cancer Institute (NCI) and the National Institutes of Health (NIH) have announced a Phase II small business innovation research (SBIR) contract to Epic Sciences for the development of a lung cancer diagnostic blood test. The ...
BG Medicine has obtained CE mark certification for its automated Galectin-3 blood test, designed for the management of chronic heart failure. The test will be made available through bioMerieux's VIDAS immunoassay, which consists of about ...
Tags: EU, CE Mark, BG Medicine, Medicine