By OMAR FORD
Medical Device Daily Staff Writer
It only took one successful assay developed by BD Diagnostics (Circle Sparks, Maryland) and Lab21 (Cambridge, UK), for both firms to realize they had something special when it comes to working together to get new products to market.
The two companies are now focused on developing polymerase chain reaction-based assays to be run off of the BD MAX, a fully automated platform. The first two assays will be designed to detect mutations in the KRAS and BRAF genes. BD will be responsible for manufacturing and commercializing the tests worldwide.
These initial assays were selected because of their current importance in optimizing the management of cancer patients. The agreement also includes the development of novel nucleic acid extraction procedures from formalin-fixed paraffin-embedded tissue.
The collaboration will develop BD's first offering in personalized cancer diagnostics on the BD MAX system.
"When used in conjunction with other laboratory and clinical information, these assays will provide critical input to support oncologists and their patients in making more informed decisions about their care," said Tom Polen, President, BD Diagnostics Diagnostic Systems.
Financial terms of the agreement and information regarding additional assays were not disclosed.
This isn't the first time the two companies have come together. In August of last year, the two firms developed a test to detect Aspergillus Gregory Meehan, VP, BD Diagnostics Diagnostic Systems, Molecular Diagnostics platform told Medical Device Daily.
"It's going very well," Meehan, said of the Aspergillus assay's success. "It's a real important assay in the infectious disease area and it targets Aspergillus in serum. Aspergillus is lethal particularly in transplant patients and patients that have a compromised immune system. This would be the first assay that can be used to monitor at risk patients for lethal Aspergillus infections and theoretically get a jump start on balancing their immune system and their antifungal therapy. We expect that product to be launched in Europe in June of this year."
In other agreements/contracts news:
Iverson Genetic Diagnostics (Bothell, Washington) reported an exclusive licensing agreement with Johns Hopkins University School of Medicine (Baltimore) under which Iverson receives global exclusive commercialization rights for molecular diagnostics that are designed to help physicians to assess cardiovascular risk in men and women and infertility risk in women.
Leroy Hood, MD, PhD, co-founder of the Institute for Systems Biology and a member of Iverson Genetic Diagnostics' Board of Directors, said, "The importance of finding gene variants that affect the metabolism of cholesterol, especially the healthy fraction, and hormones - hence causing disease - is incredibly important for personalized medicine. This agreement between Iverson and Johns Hopkins is a wonderful example of a diagnostic test that could significantly improve the health of many patients throughout the world."
RainDance Technologies (Lexington, Massachusetts) and Integrated DNA Technologies (IDT; Coralville, Iowa) a developer in oligonucleotide synthesis, reported a collaboration focused on consumables specifically tailored to perform the fast-growing application of digital PCR.
The companies will work together on the development of reagents compatible with the RainDrop Digital PCR System. Financial terms of the agreement were not disclosed.
The RainDrop Digital PCR System is a breakthrough research platform that is transforming the performance of molecular assays by enabling digital answers across a number of important applications including low-frequency tumor allele detection, gene expression, copy number variation, and SNP measurement.
Built using RainDance's proven RainStorm picodroplet technology, the RainDrop System generates up to 10 million picoliter-sized droplets per sample. Since each droplet encapsulates no more than a single molecule, researchers can quickly determine the absolute number of droplets containing specific target DNA and compare that to the number of droplets with background, wild-type DNA.
HemoSonics (Charlottesville, Virginia) has chosen technology design and development firm Cambridge Consultants (Cambridge, UK) to finalize the development of its new diagnostic instrument. The device will provide critically needed data to guide the treatment of bleeding and blood clots in surgery, trauma and intensive care.
The Point-of-Care (POC) analyzer is being designed to test the four treatable systems that control clotting: platelets, coagulation factors, fibrinogen and fibrinolytic proteins. Disruption or imbalance of these systems causes life-threatening bleeding and blood clots, which can result in heart attack, stroke, pulmonary embolism and hemorrhage. These conditions are responsible for 30% of deaths in the developed world. The HemoSonics technology is intended to rapidly diagnose these disruptions for physicians to implement life-saving therapy.
"After a highly competitive search, we chose Cambridge Consultants due to its proven expertise and track record in the medical technology and surgical space," said William Walker, president of HemoSonics. "We are excited to work collaboratively through the commercialization process to take this important product to market. Most people don't realize that bleeding and blood clots are the main causes of death in the developed world. This diagnostic instrument is being designed to provide information rapidly to physicians to allow them to reduce complications for the patient, and, in turn, save lives and lower healthcare costs."
The new device is being developed for its first application in open-heart surgery, where up to 25% of patients suffer from excessive bleeding.
Today, doctors have two unattractive treatment options. First, they can send blood to a lab to perform an array of tests and wait for results in the operating room a process that is unacceptably slow and is therefore rarely used. Alternatively, they can make a best guess, without hard data, to guide treatment. This process has been shown to waste blood products, increase costs, and worsen patient outcomes. The HemoSonics POC analyzer is being designed to-be-easy to use, and to rapidly provide straightforward data to physicians.
The Premier (Charlotte) healthcare alliance reported a new agreement for pediatric car seats and transport equipment has been awarded to Care Line (Greenbrier, Tennessee), a veteran-owned business.
Effective October 1, 2012, the agreement is available to acute care and continuum of care members of Premier.
Omar Ford, 404-262-5546;
Published October 16, 2012