The Natick, Mass.-based cardiac device giant is studying whether Waltham, Mass.-based BG’s diagnostic can identify patients in need of cardiac-resynchronization therapy using patient data from its Madit-CRT clinical trial.
That trial examined 1,820 patients with ischemic or non-ischemic cardiomyopathy over four-and-one-half years to compare implantable cardioverter defibrillator therapy alone with CRT defibrillator treatment.
The galectin-3 test screens for the presence of a protein that is both a predictor and the cause of a certain type of heart failure. CEO Pieter Muntendam told MassDevice that the test can help identify patients whose heart muscles are gradually stiffening by tagging people with high levels of galectin-3. The stiffening that occurs during heart failure can cause the heart’s ventricles to beat out of sync, a condition treatable with CRT.
The BGMD/BSX deal also involves BG’s biomarker discovery tools for identifying other biomarkers that might correlate to patients’ response to CRT treatment, according to BG.
It’s the latest instance of what Muntendam calls an innovative business model for developing and commercializing diagnostics. BG brought its test through clinical trials and the regulatory process (the test won 510(k) clearance from the FDA in November 2010 and landed CE Mark approval in the European Union earlier this year) and onto the market in a simple, “manual” form. Then it negotiated a series of deals with big-name diagnostics firms — including Abbott (NYSE:ABT), Siemens (NYSE:SI), Alere (NYSE:ALR) and BioMérieux (EPA:BIM) — to develop versions for those companies’ high-throughput automated machines.
Here’s a roundup of companies announcing new distribution deals, licensing agreements and other joint ventures.
- Veryan hires Pan Globus for clinical trial consulting
Veryan Medical has appointed healthcare business consultancy Pan Globus to help proctor the European clinical trial of its new BioMimics 3D stent technology.
- Tethys and Duke commence diabetes research
Tethys Bioscience Inc. and Duke Clinical Research Institute (DCRI) have established the PREVAIL patient registry, a multi-center, national initiative that will analyze primary care ambulatory practices for risk factor management of patients at high risk of conversion to type 2 diabetes in the US. The objective of PREVAIL is to improve physician use of evidence-based intervention practices that can be effective in preventing type 2 diabetes and associated cardiovascular events.
- Konica Minolta Opto extends licensing deal with Guided Therapeutics
Guided Therapeutics Inc. OTC:GTHP) announced that Konica Minolta Opto Inc. of Tokyo has extended its licensing agreement to co-develop non-invasive cancer detection products. Under terms of the agreement, Konica will pay Guided a $750,000 fee to extend the agreement for one year. This is in addition to approximately $1.7 million the company expects to receive, over the course of the next year, for the co-development of its first product in conjunction with Konica for the detection and monitoring of esophageal pre-cancer called Barrett’s esophagus.
- Chinese regenerative medicine co. adopts ThermoGenesis stem cell tech
ThermoGenesis Corp. (NSDQ:KOOL) said that regenerative medicine company Nanshan Memorial Medical Institute will be utilizing its AXP AutoXpress (AXP) and BioArchive Systems used to process and store stem cells from cord blood in its two stem cell banks in China.
- SuperNova inks deal with KSB Diagnostics
SuperNova Diagnostics Inc., a privately-held global diagnostics company for human and non-human health applications, announced that it has signed an agreement with Shenzhen Kang Sheng Bao Bio-Technology Co. Ltd. a biotechnology diagnostics company specializing in research, manufacture and distribution of in-vitro diagnostic kits and research reagents in China and affiliated markets for the research, development, manufacture and commercialization of diagnostic products and services for the measurement of Neopterin, its metabolites and derivatives utilizing the SuperNova technology platform of AmpCrystal.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.