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Agreements

Date: 2015-02-20

Type of information: Opening of new premises

Compound: emPCR portfolio of patents, liquid biopsy RAS biomarker testing center

Company: Roche (Switzerland) Sysmex Inostics (USA-Germany)

Therapeutic area: Cancer - Oncology - Technology - Services

Type agreement: licensing - opening of new premises

Action mechanism:

  • Through emulsion PCR (emPCR), each DNA molecule is individually isolated within its own bubble in a water/oil emulsion, which includes a capture bead and PCR amplification reagents. As a result, even though about a million molecules are prepared simultaneously, each molecule is individually amplified to one single bead, the equivalent of having a million separate PCR reactions. This technique allows for massive parallelization (high throughput) that results in a significant cost advantage over Sanger sequencing.

Disease:

Details:

  • • On February 21, 2014, Roche has announced a licensing agreement with Sysmex Inostics  for its emPCR portfolio of patents. Under the terms of the licensing agreement, Roche grants Sysmex Inostics a worldwide, non-exclusive, royalty-bearing license. Sysmex Inostics GmbH is primarily a clinical service lab providing analysis of free circulating tumor-DNA in plasma for prediction of drug response and for monitoring of cancer by quantifying the amount of tumor DNA to detect relapse and to detect resistance mutations, utilizing emPCR technology.

Financial terms:

Latest news:

  • • On February 20, 2015, Merck Serono announced that the first liquid biopsy RAS biomarker testing center has opened in Vall d’Hebron’s Institute of Oncology, Barcelona, Spain, and will initially test patients as part of its research program. This is an important milestone in making the new liquid biopsy RAS test available to patients with metastatic colorectal cancer (mCRC), and a significant step forward in Merck Serono’s collaboration with Sysmex Inostics GmbH, Hamburg, Germany. The liquid biopsy method, also known as blood-based biomarker testing, is a simplified and rapid approach for determining the RAS (KRAS and NRAS) mutation status of tumors, as it requires a single blood draw, rather than a tissue biopsy or surgical procedure. The liquid biopsy RAS biomarker test will help to advance precision medicine, and also has the potential to provide mutation status results within days, helping to guide treatment decisions. The liquid biopsy RAS biomarker test is expected to receive its European Conformity approval (CE mark) in the coming months, making it accessible to a wider population of mCRC patients. The test will then be implemented in numerous medical centers across the world. The Vall d’Hebron Institute of Oncology will be the first test center of its kind, with further laboratories to be established throughout 2015, including in Australia, France, Germany, Italy and the UK, among others. Vall d’Hebron’s Institute of Oncology will use blood samples from mCRC patients to advance research into RAS biomarkers. The ability to test for these mutations at Vall d’Hebron with a potentially quicker and easier testing method could improve the standard of care for patients.

Is general: Yes