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Tag Archives: Roche—

Roche launches IVD pan-TRK IHC assay

Nov. 29, 2018—Roche announced the worldwide launch of the Ventana pan-TRK (EPR17341) Assay, an automated in vitro diagnostic immunohistochemistry assay to detect tropomyosin receptor kinase proteins in cancer. The CE IVD/U.S. class I assay is designed to detect C-terminal protein expression, which allows for the detection of TRK-fusion as well as wild-type protein expression. “As the first test of its kind, ...

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Study: Kadcyla improved invasive disease-free survival

November 2018—Roche announced the phase three KATHERINE study met its primary endpoint, showing Kadcyla (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival) compared with trastuzumab as an adjuvant treatment in people with HER2-positive early breast cancer who have residual disease present following neoadjuvant treatment.

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Roche announces availability of FoundationOne Liquid

Sept. 27, 2018—Roche announced that its FoundationOne Liquid, a blood-based genomic profiling test, is available worldwide. FoundationOne Liquid can identify circulating tumor DNA in the blood of people with cancer and can identify 70 of the most commonly mutated genes in solid tumors, including microsatellite instability.

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MU School of Medicine, Roche team up

September 2018—Roche announced the result of a collaboration with the University of Missouri School of Medicine to implement the company’s Navify tumor board solution, cloud-based clinical workflow and decision-support software to assist with cancer patient case reviews in tumor board and multidisciplinary team meetings.

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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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