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During the past month and a half, pharmaceutical giant Merck has been actively forming partnerships with IVD manufacturers to develop companion diagnostics for their drugs. The following is a rundown of these recent alliances.

At the end of May, Dako, an Agilent Technologies company, announced a collaboration with Merck & Co. to develop a companion diagnostics test for the analysis of the potential tumor biomarker PD-L1 to aid in the treatment of cancer. Earlier this year, Dako entered into a master framework agreement with Merck to develop companion diagnostics for oncology drugs currently in Merck’s development pipeline.

“Partnering with other companies that share our commitment to fighting cancer allows us to aid in the selection of patients most likely to respond to specific cancer therapies,” said Jacob Thaysen, vice president and general manager for Agilent’s diagnostics and genomics business.

The companion diagnostic test coming out of this collaboration will be evaluated as part of the clinical development program for Merck’s investigational anti-PD-1 antibody being studied for the treatment of cancer.

“Early findings from Merck’s broad clinical development program have provided evidence for the potential of PD-L1 tumor expression to aid study enrichment and patient selection in some tumor types,” said Eric Rubin, vice president, oncology, Merck Research Laboratories.

This deal was literally followed a couple of days later by another announcement in early June that Sysmex Inostics, a subsidiary of Sysmex Corp., reached a collaboration agreement with Merck, through its biopharmaceutical division Merck Serono, for the development and commercialization of a RAS diagnostic kit for patients with metastatic colorectal cancer.

“Together, with our noninvasive, blood-based diagnostics and Merck’s expertise in personalized medicine, we will open up new possibilities to advance biomarker testing in metastatic colorectal cancer,” said Fernando Andreu, chief executive officer of Sysmex Inostics. “This collaboration is another step in enhancing the clinical value of Sysmex Inostics’ tests and exemplifies Sysmex’s overall strategy to bring sensitive blood-based testing to the oncology field.”

Under the terms of this agreement, Sysmex will develop blood-based RAS diagnostic tests based on its BEAMing technology for patients with metastatic colorectal cancer. Sysmex’s BEAMing tests enable a sensitive analysis of circulating tumor DNA that is shed into the blood stream. These tests provide a noninvasive alternative to traditional biopsies in determining the mutational status of a patient’s tumor. They also allow for the selection of an appropriate therapeutic agent without the need for further surgeries or biopsies.

“We have embraced the principles of personalized medicine and predictive biomarkers,” said Belén Garijo, president and chief executive officer of Merck Serono. “This collaboration reflects our commitment to leveraging our expertise in personalized medicine and predictive biomarkers in order to enhance Erbitux’s value proposition for patients, physicians, and payers.”

And just last week, Ventana Medical Systems Inc. entered into an agreement with Merck KGaA to collaborate with Merck’s biopharmaceutical division on the development and commercialization of a companion diagnostic for an undisclosed target using Ventana’s proprietary diagnostic assays. In alignment with Merck’s strategic approach in personalized medicine, the aim is to develop a patient stratifying IVD test that can be used in multiple cancer indications. As part of the agreement, Ventana will develop and validate the companion diagnostics and ensure its readiness, availability, and adherence to FDA and other health authority standards for future clinical trials.

“Tailoring therapies based on a patient’s specific genes, proteins, or tissue environment is a key expansion area for oncology,” said Doug Ward, vice president, companion diagnostics, Ventana Medical Systems. “Ventana is committed to continuing to provide biomarker detection using our proprietary assays as the basis for companion diagnostic tests.”

I was intrigued by this recent flurry of companion diagnostics development activity at Merck. I contacted Merck to find out more about the company’s business strategies regarding companion diagnostics. The following are Merck’s answers to my questions:

Q: Besides Dako, Sysmex, and Ventana, what other IVD manufacturers is Merck currently working with to develop companion diagnostics?
Merck: Merck is in contact with various global IVD companies to select collaborations in the best interest of the development programs. Besides the aforementioned companion diagnostics collaborations, we have a collaboration with Life Technologies, and we are currently discussing with a number of other IVD companies on further joint diagnostic developments.

Q: What are Merck’s overall views about companion diagnostics?
Merck: Advancements in personalized medicine are revolutionizing both clinical research and the way healthcare is delivered to patients. Companion diagnostics will assist physicians in making treatment decisions based on the understanding of the benefit and risk profile of a treatment for a targeted, molecularly defined patient population.

Q: What other therapeutic products is Merck looking to develop companion diagnostics for? Is Merck actively looking for IVD manufacturers to partner with to develop these companion diagnostics?
Merck: Merck Serono is evaluating the opportunity for patient stratification in every clinical program. To develop companion diagnostics, Merck Serono collaborates with experienced, global IVD companies, leveraging on joint expertise and creating valuable solutions for the benefit of the patient and the public health systems.

Q: Is the development of companion diagnostics an important part of Merck's long-term business strategy?
Merck: Merck Serono was one of the first pharmaceutical companies that provided the benefit of personalized medicine to patients. Companion diagnostics are essential for patient stratification. Therefore, companion diagnostics collaborations with IVD companies will substantially contribute to the success of Merck Serono’s long-term business strategy.

Q: Why did Merck sign a companion diagnostics deal with Sysmex?
Merck: Merck has embraced the principles of personalized medicine and predictive biomarkers. The partnership with Sysmex Inostics is part of our commitment to making these principles a reality for patients, physicians, and payers. We believe that testing for RAS mutations at the time of diagnosis for metastatic disease will help inform the clinicians’ decision on selecting the optimal treatment strategy for their patients and ultimately help improve patients’ outcomes. As blood-based testing is a noninvasive and faster approach for determining the RAS biomarker status of metastatic colorectal cancer tumors, this new testing approach can help guide treatment decision-making, ensuring clinicians can select the right treatment for their patients, right from the start.

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