The head of Roche Diagnostics today highlighted the company's PCR-based tests for human papillomavirus and methicillin-resistant Staphylococcus aureus as potential key drivers of expected continued growth in the coming year of the company's diagnostics business.
Asuragen, Life Tech launch BCR/ABL1 Quant test in Europe; Palex Medical to distribute Molecular Detection’s MRSA assay in Spain; Meridian Biosciences gets FDA nod for C. difficile molecular amplification assay.
Abaxis claims that Cepheid's PCR-based blood test for methicillin-resistant Staphylococcus aureus infringes its sample prep patents. In response, Cepheid has filed a counterclaim denying the alleged infringement and asking the court to find that Abaxis' patents are invalid.
"Although the product appears to continue to meet performance claims as outlined in the current product labeling, an ongoing failure investigation has identified the emergence of novel MRSA strain types as one of the causes of false-negative MRSA results."
The new program applies core technologies from across the company to combine one sample-preparation step with one instrument platform for real-time PCR based detection of Mycoplasma, vesivirus 2117, and mouse minute virus.
Around a dozen H1N1 tests have gained EUA approval since the FDA gave its first EUA last April for CDC's PCR-based test. However, only two of these assays have received 510(k) clearance, which allows them to be used beyond the EUA.
The antibody profile could potentially be used to improve stratification of patient cohorts in clinical trials or as a point-of-care test to determine whether a patient needs vaccination, Reinhard Hiller, managing director of CPGR, told ProteoMonitor.
The new funds follow a $3.3 million Series C financing round closed in late 2009. MDI will use the money to further develop its pipeline of qualitative real-time PCR in vitro diagnostic tests for infectious diseases.