The partnership between Qiagen and NeoGenomics, will ensure the availability of Day-One patient access to FDA-approved molecular tests paired with newly approved drugs for cancer.
The collaboration with NeoGenomics will allow Qiagen and pharmaceutical partners to streamline the development of launch of targeted drugs, with companion diagnostics guiding the treatment decisions.
Through this partnership, flexible pathways can be introduced, which can lead to the introduction of FDA-approved companion diagnostics simultaneously with the launch of new therapies.
Qiagen CEO Peer Schatz said: “We are excited to collaborate with NeoGenomics to ensure immediate availability of QIAGEN companion diagnostics during clinical trials and upon approval by the FDA, supporting synchronized launches of new oncology drugs, to make a difference for patients.
“Together with our Pharma partners, we are now planning to provide investigational use only (IOU) tests to NeoGenomics and other labs, enabling them to verify, set up and run our companion diagnostics in clinical trials and in anticipation of regulatory approval.”
Qiagen and NeoGenomics will discuss about expediting the access for precision medicine solutions at the American Society of Hematology (ASH) 2018 Annual Meeting and Exposition between 1 and 4 December, this year in San Diego.
NeoGenomics chairman and CEO Douglas M. VanOort said: “As a leading provider of oncology testing for both clinical trials and patient care, NeoGenomics is uniquely positioned to assist pharmaceutical and biotech companies to develop and commercialize companion diagnostic tests. Our collaboration with QIAGEN will ensure that patients have access to the most advanced companion diagnostics to target new cancer medicines, as soon as those medicines are approved.
“We are excited to work with QIAGEN to deploy cutting edge technologies to remain at the forefront of precision medicine.”
NeoGenomics has a footprint across the US, with broad customer reach in cancer-related genetic testing services and comprehensive oncology-focused test menus.
The master service agreement between the two companies includes flexible framework with multiple options for co-development, verification, setup and launch of new companion diagnostics such as sequencing tests, for biomarker profiling paired with new targeted drugs.
Douglas VanOort continued saying: “The companion diagnostic services can be promoted by NeoGenomics through their national commercial teams starting with their FDA approval, facilitating the rapid adoption of innovative targeted therapies which can deliver meaningful benefits to patients. We look forward to discussing this approach further at ASH 2018, and demonstrating our rapidly evolving Sample to Insight solutions to the world’s top hematology and oncology experts.”