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MDx/CDx Focus: Diaceutics, CAHG Launch Bioceutics; LabCorp Submits IDE for Gencaro CDx


Diaceutics, CAHG Launch Personalized Rx-Focused Marketing, Educational Firm Bioceutics

Healthcare communications firm CAHG and consulting firm Diaceutics have launched a company called Bioceutics, which will help clients develop communications strategies, as well as educational and marketing campaigns around personalized medicine.

According to the partners, Bioceutics will employ different strategies than traditional pharmaceutical marketing. “This new business model integrates fragmented stakeholders by focusing on the ways in which a patient's journey from symptoms through diagnosis to treatment can be significantly altered when new tests are introduced along the way and when stakeholders receive enhanced education and communication,” Diaceutics and CAHG said in a statement.

According to Diaceutics, broader adoption of personalized medicine is hindered by the lack of physician education, by excluding pathologists and labs in educational efforts, and by undervaluing the importance of tests in delivering precision medicine.

"If the first decades of personalized healthcare were about translation of the new science into therapies and tests, the next decade requires a greater focus on how novel therapies and tests will be used to transform the care pathway," said Suri Harris, Bioceutics' Executive VP of strategic planning and new ventures. "Not many have realized that with the arrival of personalized healthcare, the marketing challenge has changed forever."

Diaceutics two years ago launched Labceutics, a laboratory network service focused on the European market. Labceutics aims to help pharma and diagnostics companies gain access to Europe's lab market and figure out how to use this untapped network to deliver tests to physicians and patients seeking to personalize treatments.

LabCorp Submits IDE for Gencaro Companion Test

The Laboratory Corporation of America has submitted an investigational device exemption (IDE) application with the US Food and Drug Administration for a proposed companion diagnostic for ARCA Biopharma's beta blocker Gencaro (bucindolol hydrochloride).

ARCA is developing Gencaro as a molecularly targeted treatment for atrial fibrillation, and the FDA has already accepted an investigational new drug application for the agent. If the FDA grants LabCorp the IDE, then the companion test can be used to pick out best responders to Gencaro in the GENETIC-AF trial.

Researchers from Duke University Medical Center, ARCA, and elsewhere published data in PLOS One last year from a retrospective pharmacogenetic analysis showing that the combination of two polymorphisms -- beta1 AR and alpha2c AR -- can be useful in determining which patients respond especially well, have an average response, or have virtually no response to Gencaro. The companion test developed by LabCorp and ARCA gauge patient genotypes based genetic variations of the beta1 receptor.

GENETIC-AF is a Phase IIb/III randomized, double-blind clinical trial comparing Gencaro to Toprol-XL for prevention of AF. Researcher will only enroll patients that have the beta-1 variant that makes them most likely to respond favorably to Gencaro. The study will enroll approximately 200 patients in the Phase IIb portion of the trial, and potentially more than 400 patients in Phase III.

ARCA is conducting the Phase IIb portion with Medtronic. In this part of the study, participants will have their heart rhythm monitored using a Medtronic device, a cardiac resynchronization or defibrillation device, or a Reveal loop recorder. Researchers will measure patients' actual time in atrial fibrillation regardless of their symptoms. ARCA has said it will move on to Phase III after interim analysis by a Data Safety Monitoring Board.

Patient enrollment is slated for the first quarter of 2014. ARCA is hoping that Gencaro will “be the first genetically-targeted AF prevention treatment.”