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Tag Archives: Roche—

FDA approves Cobas HPV Test with SurePath

Aug. 3, 2018—Roche has received FDA approval for the Cobas HPV Test to be used as the first-line screening test for cervical cancer in women 25 and older using specimens collected in SurePath preservative fluid. The Roche test is now the only HPV test approved for use as a primary screening test with both SurePath and ThinPrep PreservCyt Solution. It ...

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Roche buys remainder of Foundation Medicine

June 25, 2018—Roche and Foundation Medicine have entered into a merger agreement for Roche to acquire the outstanding shares of FMI’s common stock not already owned by Roche for $2.4 billion. The companies will focus on using FMI’s comprehensive genomic profile testing to develop treatments for patients with cancer. Foundation Medicine will continue to operate independently. “This is important to ...

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Roche showcases new test options at ASM Microbe

June 8, 2018—Roche will feature at ASM Microbe 2018, in Atlanta, new test options that aim to expand the opportunities for laboratories to automate molecular testing. The company is introducing its CT/NG test for its Cobas 6800 and 8800 systems. The test, which was cleared by the FDA in April, allows laboratories to consolidate STI testing with Roche’s viral load ...

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Roche to acquire Ignyta, 4/18

April 2018—Roche will acquire San Diego–based Ignyta for $27.00 per share in cash, or $1.7 billion. Ignyta, which will continue its operations in San Diego, focuses on precision medicine in oncology aiming to test, identify, and treat patients with cancers harboring specific rare mutations.

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CE-marked Cobas Plasma Separation Card, 4/18

April 2018—Roche launched the Cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing. By requiring only a small amount of a patient’s blood from a fingertip, this card simplifies blood collection and sample transportation, as compared with traditional plasma-based testing.

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Roche, GE to develop digital diagnostics platform, 4/18

April 2018—Roche and GE Healthcare will partner to develop and co-market digital clinical decision support solutions. The companies aim to develop a digital platform using analytics to provide workflow solutions and apps that support clinical decisions. This will allow the integration and analysis of in vivo and in vitro data, patient records, medical best practices, real-time monitoring, and the latest research outcomes.

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FDA approves Roche’s alectinib product

Nov. 27, 2017—Roche announced that the FDA approved the supplemental new drug application for Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test. The approval is based on results from the phase III Alex study, which showed Alecensa significantly reduced the risk of disease worsening or death ...

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Roche to acquire Viewics

Nov. 20, 2017—Roche announced today it will acquire Viewics, a privately held software company focused on laboratory business analytics. This acquisition allows Roche to expand its position in the integrated core lab with business analytics capabilities, enabling laboratories to make faster, data-driven informed decisions on their operations and processes. The cloud-based solution is secure, infrastructure agnostic, interactive, and accessible from ...

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FDA clears Roche panel for colorectal cancer

Nov. 14, 2017—Roche announced today FDA clearance of the Ventana MMR IHC Panel, which provides clinicians with a group of immunohistochemistry tests for patients diagnosed with colorectal cancer. The tests detect certain proteins associated with a DNA repair mechanism called mismatch repair and aid in differentiating between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal cancer. ...

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