The formation of the new subsidiary, called Pacific Biomarkers, was hailed as the "next step" in an "aggressive entry" being made by the firm into the biomarker services space.
"We are seeing the continued evolution of clinical drug development towards increased reliance on biomarkers to guide development and improve the safety and efficacy of novel drugs", said Pacific Biometrics CEO, Ron Helm.
"The company is fully committed to becoming a significant player in outsourced clinical biomarker services and we expect to see substantial growth in backlog and revenues associated with these services in the medium and long term… we are observing a strong demand going forward," he said.
The firm's Clinical Biomarker Services division, which was launched six months ago and conducts laboratory validation of ligand-binding assays for immunogenicity testing and novel biomarkers, has been transferred to the new subsidiary.
Helm noted that immunogenicity testing in particular is a specific requirement for biologic drugs and "represents an area of growing demand".
Dr Mario Ehlers, Pacific Biometrics' chief medical officer, will move to serve as the president and CEO of the new venture.
Dr Ehlers said that the formation of Pacific Biomarkers is "exciting", because it positions the company not only to begin providing these specialty contract services for drug development, but also to take a proprietary position in novel biomarkers when the opportunity presents itself.
"The market is moving towards a model where companion diagnostics are an essential component of new therapeutics… as we move forward with testing services on a contract basis, we [will also] search for potential in-licensing and product-development opportunities."
It is anticipated that over the next few years, companion diagnostics will be of increasing importance in healthcare by enabling therapy decisions to be linked with information and guidance provided by specific, personalised diagnostic test results.
Companion diagnostic assays may have a variety of clinical uses, including the assessment of the potential efficacy or toxicity of a drug.
Additionally, the US Food and Drug Administration (FDA) has also been gently encouraging the biopharmaceutical industry to develop companion diagnostics in parallel with some of the more targeted therapies that are now being developed, so as to better select patients and treatment protocols that are most suited for the clinical trials of these selective therapies, and thus minimise the number of unnecessary adverse drug events and more successfully reach the trial end point.
Other preclinical services firms such as US firm Laboratory Corp and UK's NextGen have also been making moves to compete in this emerging services area of late.