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 ...
Molecular diagnostic company Myriad Genetics has launched myRisk Hereditary Cancer, a new multi-gene diagnostic test for hereditary cancer testing. The new test analyses 25 genes that are associated with breast, colorectal, ovarian, ...
Tags: Multi-Gene Test, Medicine
The US Food and Drug Administration (FDA) has approved the first rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 antigen in human serum, plasma, and venous or fingerstick whole blood specimens. The Alere ...
Tags: Rapid Diagnostic Test, HIV-1, HIV-2
US-based BioFire Diagnostics has begun clinical and analytical studies to evaluate its FilmArray Gastrointestinal (GI) Panel. This clinical study is being conducted at several hospital-based clinical laboratories in the US and is funded ...
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 ...
US-based company Arno has entered into partnership with Veridex, a Johnson & Johnson company, to develop a diagnostic test that detects the presence of activated progesterone receptors (APRs) as a biomarker of anti-progestin activity in ...
Tags: Arno, Diagnostic Test
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 ...
Corgenix Medical has received the notification of CE Mark for its Relasv antigen rapid test for Lassa fever diagnosis. Relasv is the diagnostic test developed by Corgenix and members of the Viral Hemorrhagic Fever Consortium (VHFC), a ...
Tags: Corgenix Medical, Rapid Test
Diagnostic company LipoScience has begun the clinical development phase of a diagnostic test based on the gut flora metabolite, trimethylamine-N-oxide (TMAO). The nuclear magnetic resonance (NMR)-based TMAO assay is expected to detect ...
Tags: Liposcience, Clinical Development
BioFire Diagnostics has submitted 510(k) pre-market notification application to the US Food and Drug Administration (FDA) seeking approval for its FilmArray blood culture identification (BCID) test. The application included positive ...
Tags: Biofire, FDA Clearance
Mobidiag, Genewave and Amplidiag have signed a definitive agreement to combine the three companies to set up a new company, which will offer integrated, high-multiplex diagnostic tests for infectious diseases. Headquartered in Helsinki, ...
Tags: Mobidiag, Genewave, Infectious Diseases
US-based T2 Biosystems has received a patent from US Patent and Trademark Office covering its T2Candida test. The patent describes the format and methodology of T2Candida test, desinged to detect and identify Candida species in a blood ...
Tags: T2 Biosystems, T2Candida test
The US Patent and Trademark Office (USPTO) has granted patent, number 8,409,807 to T2 Biosystems' patent application covering its T2Candida diagnostic test. The test identifies and detects sepsis-causing Candida species from whole blood ...
Tags: T2 Biosystems, T2candida Test, Patent