|QIAGEN Announces European Launch of Therascreen IDH1/2Test for Gliomas; Results of Pluristem's Phase I/II Muscle Injury Trial to be Announced|
|By Staff and Wire Reports|
|Monday, 06 January 2014 20:02|
QIAGEN N.V. today announced the European launch of its new therascreen® IDH1/2 RGQ Kit, enabling physicians to better diagnose and assess the prognoses of patients with gliomas, or tumors of the brain and spinal cord. The test is based on QIAGEN's proprietary biomarkers for IDH1 and IDH2 gene mutations. The therascreen® IDH1/2 RGQ Kit has received CE marking enabling marketing in Europe and certain other markets. In addition, QIAGEN announced a new collaboration with Mayo Clinic to develop diagnostics for cholangiocarcinoma (CCA), also known as bile duct cancer, using biomarkers for the IDH1 and IDH2 mutations.
The therascreen IDH1/2 RGQ PCR Kit enables detection of 12 mutations in the IDH1 and IDH2 genes in a single test using real-time PCR. Mutations in IDH1/2 are recognized as prognostic markers for gliomas (NCCN 2013, EFNS 2010), and the therascreen IDH1/2 RGQ PCR Kit will aid clinicians in classifying the tumors and prognosticating the course of this serious disease.
"We are pleased to introduce a standardized, reliable IDH1/2 diagnostic test that improves clinical understanding and treatment of gliomas by genetically characterizing each person's disease. QIAGEN's assay for IDH1/2 mutations was designed in close collaboration with leading clinicians to rapidly provide meaningful information about their patients' gliomas," said Vincent Fert, QIAGEN's Personalized Healthcare Program Leader. "This new product strengthens QIAGEN's Personalized Healthcare portfolio, especially the assay offering for neuro-oncology, which also include CE-marked therascreen MGMT and BRAF tests. The IDH1/2 kit also adds to the growing menu of tests that run on our flexible sample-to-result QIAsymphony platform which allows an improved laboratory workflow."
QIAGEN also announced a partnership and licensing options with Mayo Clinic in Rochester, Minnesota, for use of the IDH1 and IDH2 biomarkers to diagnose and guide the treatment of cholangiocarcinoma. CCA is a rare form of cancer, originating in the bile duct that affects approximately 2,000 to 3,000 patients each year in the United States. QIAGEN and Mayo Clinic, which was also involved in the validation study of the new therascreen® IDH1/2 RGQ Kit, will collaborate on development of new IDH1/2 products for CCA.
Pluristem Therapeutics Inc. (NasdaqCM: PSTI; TASE: PLTR), today announced that the results of the company’s Phase I/II clinical trial testing the safety and efficacy of PLacental Expanded (PLX-PAD) cells for the treatment of muscle injury will be presented on January 21, 2014.
The Principal Investigator of the study will join Pluristem’s management to discuss these results as part of Pluristem’s Regenerative Medicine Day to be held on the above date at the Tel Aviv Stock Exchange, Tel Aviv Israel.
This randomized, placebo-controlled, double blinded study was conducted at the Orthopedic Clinic on the campus of the Charité University Medical School under the auspices of the Paul-Ehrlich-Institute (PEI), Germany’s health authority. The injured muscle studied was the gluteal buttock muscle that has been surgically traumatized during total hip replacement surgery.
The study was comprised of 3 treatment groups, two PLX-PAD groups of different doses and one placebo group. The primary endpoints of the study include safety and the maximal contraction force of the gluteal muscle at six months post-surgery. The secondary efficacy endpoints include an analysis of the macrostructure and microstructure of the gluteal muscle using magnetic resonance imaging (MRI) and biopsy.
“We look forward to receiving the results from this important orthopedic study. Data from this clinical trial will give us information regarding other potential surgical orthopedic injuries and non-surgical sports related injuries for which our PLX-PAD cells may be beneficial,” stated Zami Aberman, Chairman and CEO of Pluristem. “This Phase I/II study marked the first time PLX-PAD cells were used to address surgically induced muscle injury.”
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