Ventana Medical Systems, Inc. has announced that it has entered into an agreement with Merck KGaA, Darmstadt, Germany, which operates as EMD Serono in the United States and Canada, to collaborate with Merck KGaA's biopharmaceutical division on the development and commercialization of a companion diagnostic (CDx) for an undisclosed target using Ventana's proprietary diagnostic assays.
In alignment with Merck KGaA's strategic approach in personalized medicine, the aim is to develop a patient stratifying diagnostic test that can be used in multiple cancer indications.
Merck KGaA, which is actively investing in innovation in the CDx field through a number of partnerships, will leverage Ventana's global leadership position in cancer diagnostics and vast expertise in CDx to achieve new levels of diagnostic clarity for the investigated target.
As part of the agreement, Ventana will develop and validate the CDx 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. We are very pleased to partner with Merck in Darmstadt, Germany to co-develop a CDx that will play a vital role in improving the quality of care for cancer patients," said Doug Ward, Vice President, Companion Diagnostics, Ventana Medical Systems, Inc. "Ventana is committed to continuing to provide the industry's gold standard in biomarker detection using our proprietary assays as the basis for novel companion diagnostic tests."
This pharma partnership is one of several currently underway where the Ventana Companion Diagnostics team is delivering patient stratifying diagnostic tests that help identify those patients who are most likely to benefit from specific treatments.
In addition to the biopharmaceutical division of Merck KGaA, Ventana has announced partnerships with Bayer, Pfizer, Boehringer Ingelheim, Takeda's Millennium unit, Genmab, Incyte, MedImmune and more.
Since 2002, the company has worked with more than 45 biopharmaceutical partners and is currently engaged in more than 180 collaborative projects to develop and commercialize companion diagnostics globally.
Companion diagnostics (CDx) are tests designed to confirm the presence of a specific biomarker to assist physicians in selecting effective therapies for their patients, based on the individual characteristics of each person.
Incorporating a companion diagnostic strategy into a drug development program may expedite the drug approval process and help generate more effective treatments with improved safety profiles for patients.