EDP Biotech, a US-based in vitro diagnostics laboratory, and diagnostic healthcare company New Day Diagnostics have agreed to merge their assets and build a new vertically integrated diagnostic firm.

The combined entity is expected to accelerate the development and commercialisation of diagnostic tests.

It will combine EDP Biotech’s position as a speciality diagnostic developer and contract research organisation (CRO) with New Day Diagnostics’ range of diagnostic tests and commercialisation expertise.

According to EDP Biotech, the merger is intended to empower patients by providing them access to affordable diagnostic tests for earlier intervention.

By combining their complementary skills and resources, both firms aim to develop a business that can enhance patient lives through diagnostics products.

The newly formed entity is anticipated to serve the entire diagnostic process, from biomarker discovery to product launch. It will also develop and implement diagnostic tests by utilising vertical integration and strategic alliances efficiently and effectively.

EDP Biotech CEO Eric Mayer said: “This strategic marriage will allow us to continue delivering innovative and cost-effective diagnostic solutions, making a profound impact on patient care and outcomes including the under-served population and uninsured patients.”

EDP Biotech is developing the ColoPlex test for the early detection of colorectal cancers and polyps. It also offers CRO services to diagnostic companies.

The firm also operates a clinical laboratory improvement amendments (CLIA) laboratory that provides business-to-business and direct-to-consumer testing, multiplex assays, research, and validation services.

New Day Diagnostics, which is based in Florida, has a range of physician point-of-care and physician mediated-direct-to-consumer (DTC) tests. It also provides DTC celiac disease tests along with tests for infectious diseases, prostate cancer, and ovarian cancer.

New Day Diagnostics founder and CEO Navroze Mehta said: “By joining forces with EDP Biotech, we are strengthening our position as a leading provider of fast, accurate, and affordable diagnostic tests.

“Together, we will pioneer advancements in diagnostic testing, improving patient lives through early detection and intervention.”

The merged entity will retain the New Day Diagnostics name. Additionally, the teams from both organisations will come together under a single leadership structure with headquarters in Knoxville, Tennessee.

The closing of the merger is subject to regulatory clearances as well as the customary closing requirements.