Pharmaceutical, biotech, and medical device contract research organization (CRO) ICON, based in Dublin, Ireland announced in its year-end earnings statement that it has acquired molecular diagnostics and research laboratory company MolecularMD. The deal, whose terms were not disclosed, provides ICON with significant reach into the area of precision medicine research and the breadth of drug-diagnostic co-development.
"We are committed to expanding the testing we offer into specialized areas so that we can help customers to maximize the value of laboratory data to accelerate timelines and reduce development costs,” said Steve Cutler, CEO of ICON, in a press release. “MolecularMD enhances our laboratory offering in molecular diagnostic testing, a key area in oncology research, and brings to ICON expanded testing platforms and diagnostic services.”
ICON, founded in 1990, has a global reach, operating central laboratories at its home base in Dublin, with additional labs in Farmingdale, NY; Singapore, and Tianjin, China. It also runs a bioanalytical laboratory in Whitesboro, NY. With the acquisition of Portland, OR-based MolecularMD, ICON expands its capabilities into molecular diagnostics and gains valuable expertise in the areas of next-generation sequencing (NGS) and immunohistochemistry (IHC) testing.
“We remain committed to providing agile clinical trial assay development across technology platforms and extending all the way through regulatory approval and commercialization of companion diagnostics,” said MolecularMD President Dan Snyder. “The integration with ICON’s full spectrum of drug development services across all therapeutic areas and global reach will be recognized as very high value to our pharmaceutical and biotechnology clients.”
According to Cutler, MolecularMD’s expertise in the oncology field and its proven track record of companion diagnostic co-development were attractive additions to its existing contract research services. This is especially true as pharmaceutical companies have invested heavily in immunotherapies for cancer, which require advanced capabilities and understanding of associated biomarkers such as PD-L1, tumor mutation burden (TMB), and microsatellite instability—all significant areas of immuno-oncology research.
For MolecularMD, the acquisition represents an opportunity for the company to bring its model to a much wider market via an established CRO with multiple central labs around the world. “Over the last 12 years, MolecularMD has established itself as a premier diagnostic partner in oncology precision medicine,” Snyder told Clinical OMICs. “In order to fully leverage what we have built, we wanted to work from a global platform and also connect our capabilities in biomarkers and companion diagnostics to the full spectrum of drug development support offering that a company like ICON represents.”
Perhaps the largest success to date for MolecularMD was the approval of its MRDx BCR-ABL companion diagnostic (CDx) for Norvartis’ tyrosine kinase inhibitor (TKI) Tasigna for the treatment of chronic myeloid leukemia (CML). The MRDx BCR-ABL CDx tests patients for major molecular response to the drug which can indicate a patient is in treatment-free remission (TFR) and can safely stop taking the treatment.
In a past interview, Snyder noted that the development of MRDx BCR-ABL CDx to test patients for TFR marked a significant advance in CML treatment and for MolecularMD as well. “The FDA-authorized MRDx BCR-ABL test ensures that physicians have the information needed to identify patients that meet the stringent eligibility criteria to attempt TFR and provides the robust sensitivity and accuracy necessary for monitoring minimal residual disease with confidence,” he said.
Work among common clients will smooth the transition for the two companies. Additionally, executives acknowledge that a similar approach and philosophy in the industry should also benefit the transition.
“We are already executing our on complementary capabilities for our clients. Their core mission is about accelerated and efficient drug development programs,” said Snyder. “That is MolecularMD’s mission as well with respect to leveraging diagnostics in precision medicine. ICON can help MolecularMD get involved earlier on the therapeutic development planning process which will be of mutual benefit to us and our clients.”