PrimeraDx, a molecular diagnostics company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its ICEPlex C. difficile assay kit and the ICEPlex system. The ICEPlex system is a multiplex real-time PCR system ...
Myriad Genetics, a US-based molecular diagnostic company, has launched a new prognostic test, Myriad myPlan Lung Cancer, for patients diagnosed with early-stage lung adenocarcinoma. myPlan lung cancer test is an RNA expression panel of 31 ...
Global biotechnology company Transgenomic has signed a collaboration agreement with PDI, a health care commercialization company, to commercialize its CardioPredict. Developed by Transgenomic, CardioPredict identifies a patient's specific ...
IntelligentMDx (IMDx) has received the US Food and Drug Administration (FDA) approval for its second automated molecular diagnostic test for use on Abbott's fully automated m2000 platform. The automated molecular diagnostic test detects ...
IntelligentMDx has secured clearance from the US Food and Drug Administration (FDA) for IMDx VanR for Abbott m2000 assay, an automated molecular diagnostic test that detects the presence of vanA and vanB genes associated with ...
Global health care company Abbott has received license from the Medical Device Bureau of Health Canada for its RealTime High Risk HPV molecular diagnostic test to detect human papillomavirus (HPV), a primary cause of cervical cancer. The ...
Trovagene has commercially launched its urine-based HPV-HR (high-risk) assay, a molecular human papillomavirus (HPV) test. Using proprietary DNA sequences, the non-invasive molecular diagnostic test will identify the presence or absence ...
Tags: Trovagene, HPV assay, HPV strains
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
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
SIRS-Lab has completed enrolling patients in a clinical study of its VYOO molecular diagnostic test, designed to detect presence of pathogens' genetic material from whole blood. The prospective, blinded multicenter study, which has ...
Tags: VYOO molecular diagnostic test, pathogens'genetic material, VYOO test