MolecularMD Corporation has announced that it has entered into an agreement with Illumina, Inc. that establishes a framework for potential collaborations with respect to the development and commercialization of sequencing-based companion diagnostics in support of biopharma drug development program(s). The agreement dovetails MolecularMD’s companion diagnostic development and FDA submission experience with Illumina’s NGS technology.
“This agreement is designed to deliver the combined power of Illumina’s NGS technologies with MolecularMD’s ability to tailor a complete clinical development solution including regulatory planning, IDE validations and centralized testing and data management for global patient enrollment and disease monitoring,” stated Dan Snyder, CEO of MolecularMD.
MolecularMD opened its advanced diagnostic laboratory in Cambridge, MA in 2012 with the objective of providing NGS solutions that support clinical trials of oncology drug programs. MolecularMD has since deployed NGS diagnostics over a broad range of drug targets and indications. The ability to support global trials with centralized testing laboratories while simultaneously obtaining necessary regulatory compliance can allow rapid deployment of Illumina based NGS solutions.
“Our goal is to enable our clients with the latest platforms and proven technologies that solve for the challenges that often arise during drug and diagnostic co-development,” stated Snyder. “The ability to collaborate with Illumina on defined projects will greatly aid our clients to mitigate risks and to accelerate their clinical trial programs.”