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Molecular Diagnostic Test
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FDA 510(K) Approval for ICEPlex System Has Been Obtained by PrimeraDx
Dec 5, 2013PrimeraDx, 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 ...
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Myplan Lung Cancer Test Was Launched by Myriad Genetics
Oct 31, 2013Myriad 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 ...
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Transgenomic Signed a Collaboration Agreement with PDI to Commercialize Its Cardiopredict
Oct 17, 2013Global 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 ...
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FDA Approval for Molecular Diagnostic Test for Abbott M2000 Assay Is Obtained by Imdx
Sep 12, 2013IntelligentMDx (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 ...
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IntelligentMdx Secured Clearanced From The US FDA for IMDX Vanr for Abbott M2000 Assay
Jul 30, 2013IntelligentMDx 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 ...
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Abbott Has Received License in Canada for Realtime High Risk HPV Molecular Diagnostic Test
May 30, 2013Global 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 ...
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Trovagene Has Commercially Launched Its Urine-Based HPV-HR Assay
Apr 2, 2013Trovagene 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
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FDA Granted Approval for Great Basin's First Molecular Diagnostic Test for C. Diff
Nov 30, 2012The 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
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Urine Is Developed by Trovagene
Nov 29, 2012US-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
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SIRS-Lab Completes Enrolling Patients in a Clinical Study of Its VYOO Test Trial
Aug 16, 2012SIRS-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
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