Therapy Areas: Respiratory
Qiagen, LabCorp Launch Collaboration to Provide Day-One Access for Patients to Innovative Companion Diagnostics at the Time of Drug Approvals
8 April 2019 - - Dutch diagnostics developer Qiagen N.V. (NYSE: QGEN) has inked a master service agreement with US-based LabCorp (NYSE: LH) to further accelerate the access of cancer patients to Qiagen's companion diagnostic products following regulatory approvals of drugs and their associated tests, the company said.

As a new participant in Qiagen's Day-One Lab Readiness program, LabCorp will be able to provide physicians and patients with faster access to new, genomically targeted drugs that are becoming increasingly important therapies for a growing variety of cancers.

LabCorp is the latest company to join the programme, and its expertise in the commercial use of companion diagnostics will help a broader range of patients gain access to innovative tools for precision medicine.

Building on the US Food and Drug Administration's modernised regulatory approach, Qiagen's Day-One Lab Readiness program enables molecular diagnostic labs to begin implementing the activities necessary to prepare for commercial launch of new drugs and IVD tests once FDA approval is obtained.

LabCorp's participation in Qiagen´s network of laboratory partners will contribute to ensuring testing readiness for a portfolio of new companion diagnostics, including tests based on next generation sequencing and qualitative polymerase chain reaction, being prepared for launches in 2019 and 2020 in several countries around the world.

As more biomarkers and new technologies are used to develop in vitro diagnostics, companion diagnostic testing is becoming increasingly complex. LabCorp's extensive experience in these areas is a strong complement to Qiagen's personalised health collaborations with leading pharmaceutical companies.

Assays for multiple indications, including novel companion diagnostics across a range of cancers including lung, breast, colorectal, bladder and eventually pan-tumor disease areas, are currently in LabCorp's Day-One Lab Readiness pipeline.

Qiagen, a Netherlands-based holding company, is a global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life.

Its sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials.

Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights.

Automation solutions tie these together in seamless and cost-effective workflows.

Qiagen provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research).

As of December 31, 2018, Qiagen employed about 5,000 people in over 35 locations worldwide.

LabCorp (NYSE: LH), an S and P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services.

With a mission to improve health and improve lives, LabCorp delivers world-class diagnostic solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported net revenues of more than USD 11bn for in 2018.
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