Medical Device Daily

BioNanomatrix (Philadelphia), a company developing a nanoscale whole genome imaging and analytic platform, reported signing a multi-year Cooperative Research and Development Agreement (CRADA) with the Radiation Biology Branch at the National Cancer Institute of the National Institutes of Health to develop methods to detect, identify and quantify DNA damage caused by ionizing radiation using BioNanomatrix’ whole genome analyzer, the Nanoanalyzer.

The Nanoanalyzer is a technology that has the potential to improve on formerly “laborious and imprecise” methods of DNA damage analysis, the company said.

Michael Boyce-Jacino, president/CEO of BioNanomatrix, told Medical Device Daily that current methods involve determining the level of cell death, or apoptosis and “looking very crudely at how many cells have been killed.”

“One of the interests that clinicians have is a finer ability to understand the damage that’s being caused, both to the tumor and good tissue, in a faster and more quantitiative way, and that’s exactly what’s happening,” Boyce-Jacino told MDD.

The Nanoanalzyer “allows us to look directly at the DNA from those cells and assess the damage done to the DNA caused by the radiation treatment,” he said.

The BioNanomatrix Nanoanalyzer is designed as an integrated system that for the first time, the company said, enables pan-genomic identification and analysis on a molecule-by-molecule basis, delivering single-molecule sensitivity in a highly parallel format. The Nanoanalyzer provides “ultra high” resolution analyses of DNA, RNA and other proteins, the company said.

“Radiation therapy remains a mainstay of cancer treatment, but clinicians are hindered in their efforts to deliver an optimal dose by a lack of information on the extent of damage to the patient from the radiation already administered,” said Han Cao, PhD, chief scientific officer of BioNanomatrix.

Through the use of a nanofluid array, the Nanoanalyzer unwinds DNA from a supercoiled structure into a linear form. Once linearized, the DNA can be evaluated to identify specific DNA aberrations in order to quantify the extent of DNA damage. This single molecule linearization technology can also be used to analyze the DNA damage from genotoxic chemotherapeutic compounds and other therapeutic modalities.

“The intent [of the agreement] is then to work on understanding how to analyze the sample and really to benchmark it against other technologies,” he said.

The CRADA is initially focused on employing the Nanoanalyzer to assess radiation-induced damage to DNA, and the agreement will continue for three years, Boyce-Jacino said. Pending successful results from these initial efforts, studies may also be performed to assess DNA damage and repair resulting from other cancer therapies, including chemotherapy. These studies may also help pave the way for discoveries regarding how cells sense and repair DNA damage, with the overall goal of improving cancer treatments.

In other agreements news:

Alltracel Pharmaceuticals (Dublin, Ireland), focused on the woundcare, oral care and cardiovascular markets, said that Nanopeutics (Liberic, Czech Republic), the company’s subsidiary dedicated to the commercialization of Nanospider technology for the global woundcare market, has signed an exclusive technology and product concept development agreement with HemCon Medical Technologies (Portland, Oregon), focused on hemorrhage control in military markets.

The conclusion to the development work, which has already begun following successful initial product tests, is expected to lead to a license and supply agreement for a range of chitosan based Nanospider woundcare technologies and products for exclusively military market use.

Siemens Medical Solutions (Mountain View, California) and Biosense Webster (Diamond Bar, California) reported an extension of their strategic alliance to now give Biosense Webster exclusive worldwide rights to distribute Siemens’ Acuson AcuNav ultrasound catheters to interventional cardiologists. Earlier this year, Biosense Webster was granted exclusive distribution rights to market the catheter to electrophysiologists.

The Siemens AcuNav ultrasound catheters are designed to provide physicians with high quality diagnostic images and Doppler blood flow information throughout the entire heart during a cardiac catheterization procedure. It was approved for marketing in 1999.

Premier Purchasing Partners (Charlotte, North Carolina), a group purchasing organization, reported new agreements for surgical instruments used in open surgical procedures have been awarded to Aesculap (Center Valley, Pennsylvania), Cardinal Health Medical Products and Services (McGraw Park, Illinois), Jarit Surgical Instruments (Hawthorne, New York), and Teleflex/PillingWeck (Durham, North Carolina).

These 36-month agreements become effective Feb. 1.

Baxa (Englewood, Colorado) said it has signed a co-marketing agreement with Viasys MedSystems, a subsidiary of Viasys Healthcare (Conshohocken, Pennsylvania) to cross-promote their respective enteral feeding products for neonates.

The agreement covers the Baxa Exacta-Med Enteral Syringes and the Viasys Corflo Anti-IV Enteral Feeding System, which combine to form a system intended to reduce the wrong-route administration of non-IV fluids for neonatal and pediatric patients.