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Dx Focus: Qiagen Therascreen IDH1/2 RGQ; Roche Cobas HSV 1&2


Qiagen this week announced that it has launched the Therascreen IDH1/2 RGQ kit in Europe and other certain markets after the test received CE marking.

The test is based on Qiagen's proprietary biomarkers for IDH1 and IDH2 gene mutations, and enables detection of 12 such mutations using real-time PCR. It is designed to enable physicians to better diagnose and assess the prognoses of patients with gliomas, or tumors of the brain and spinal cord.

"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," Vincent Fert, Qiagen's personalized healthcare program leader, said in a statement.

The new product strengthens Qiagen's personalized healthcare portfolio, especially its neuro-oncology assay products such as the CE-marked Therascreen MGMT and BRAF tests. The IDH1/2 kit also adds to the growing menu of tests that run on Qiagen's sample-to-result QIAsymphony platform, the company said.

Qiagen also announced a new collaboration and licensing option with Mayo Clinic to develop diagnostics for cholangiocarcinoma (CCA), also known as bile duct cancer, using biomarkers for the IDH1 and IDH2 mutations. Under the agreement, Qiagen and Mayo Clinic, which also helped validate the Therascreen IDH1/2 RGQ Kit, will collaborate to develop new IDH1/2 products for CCA.

Roche this week announced CE IVD marking and commercial launch of the Cobas HSV 1 and 2 test for the direct detection of HSV-1 and HSV-2 DNA in anogenital specimens.

The Cobas HSV 1 and 2 test is performed on the Cobas 4800 system, features dual target detection and automation, and provides laboratories with the capability to report up to 94 results in significantly less time than traditional methods and provides a simplified workflow for sample handling in the laboratory, Roche said.

"Clinical management of patients infected with HSV type 1 or type 2 requires a clear understanding of the virus, and as resistance to antiviral agents continues to evolve, there are increasing concerns about the plasticity of the HSV genome," Raj Patel, consultant genitourinary medicine/HIV physician and senior lecturer at the University of Southampton, UK, said in a statement.

"The innovative dual target approach of the Cobas HSV 1 and 2 test allows the detection of two distinct, conserved regions of the HSV genome, providing accurate detection of the virus and peace of mind when managing patients," Patel added.

The Scan

Review of Approval Process

Stat News reports the Department for Health and Human Services' Office of the Inspector General is to investigate FDA's approval of Biogen's Alzheimer's disease drug.

Not Quite Right

A new analysis has found hundreds of studies with incorrect nucleotide sequences reported in their methods, according to Nature News.

CRISPR and mRNA Together

Time magazine reports on the use of mRNA to deliver CRISPR machinery.

Nature Papers Present Smartphone Platform for DNA Diagnosis of Malaria, Mouse Lines for Epigenomic Editing

In Nature this week: a low-cost tool to detect infectious diseases like malaria, and more.