NEW YORK (GenomeWeb) – Qiagen said after the close of the market on Wednesday that Laboratory Corporation of America has joined its "Day-One" lab readiness program designed to expedite patient access to Qiagen companion diagnostic products following regulatory approval of the tests and associated drugs.
Qiagen's Day-One program is intended to enable molecular diagnostic labs to begin preparing for commercial launch of new drugs and in vitro diagnostic tests being developed by Qiagen and its partners once US Food and Drug Administration approval is obtained.
This includes "pre-approval preparation of workflow implementation, training, assay verification, forecasting, medical communication, and reimbursement to ensure immediate test readiness," Thierry Bernard, senior vice president and head of Qiagen's molecular diagnostics business, said in a statement.
These tests include companion diagnostics based on next-generation sequencing and qPCR being prepared for launches in 2019 and 2020 in several countries. An example of such a test would be a Qiagen-developed companion diagnostic to guide the use of a Novartis investigational PI3K inhibitor in certain breast cancer patients.
Qiagen said that companion diagnostics for a wide 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 has struck similar lab readiness deals with Japan's SRL and NeoGenomics.
Financial terms of the agreement were not disclosed.