A Diagnostics & Imaging Week

Lantheus Medical Imaging (North Billerica, Massachusetts) said it has signed an agreement with NTP Radioisotopes, a subsidiary of the South African Nuclear Energy Corporation (both Pretoria, South Africa), to manufacture and supply Lantheus with an ongoing volume of molybdenum-99 (Mo-99), a key isotope used in medical imaging procedures.

According to the company, global shortfalls of Mo-99 have recently impacted the availability of critical diagnostic imaging procedures, causing concern within the medical imaging industry. Mo-99 is the parent isotope of technetium-99m (Tc99m), the most widely utilized radioisotope in the world for molecular and nuclear diagnostic imaging procedures, Lantheus said. There are only a few major suppliers of nuclear-reactor generated Mo-99 in the world. Mo-99 is primarily imported into the U.S. from aging and increasingly less reliable nuclear reactors. Recent problems within the global reactor structure have created instability in the supply of Mo-99, affecting the availability of the medical isotope to technetium generator manufacturers. Without adequate supply of Mo-99, crucial imaging tests must be canceled or postponed with potentially negative consequences for patients.

Lantheus says this agreement underlines its commitment to investing in a supply chain diversification strategy and providing new solutions to address the "limited and fragile global Mo-99 supply chain," as evidenced by the current NRU reactor shutdown in Canada, the company said.

Lantheus is set to receive a specified supply of Mo-99 at regular intervals from NTP, enhancing the company's ability to meet and/or exceed customer demand, it said. NTP has, in turn, partnered with Belgian radiochemical producer IRE to co-supply the Lantheus requirement and thereby maximize security of ongoing regular supplies of Mo-99 to Lantheus. IRE and NTP have a "long and successful relationship as reliable and consistent suppliers of Mo-99 to key customers," Lantheus noted.

"Partnering with NTP Radioisotopes as a reliable supplier of Mo-99 will provide us with expanded access within a limited supply chain. This partnership will bring our complementary skillsets and commitment to quality and reliability together to ensure patients have uninterrupted, timely access to needed medical imaging procedures that can diagnose life-threatening conditions such as heart disease and cancer," said Don Kiepert, president/CEO of Lantheus. "Diversification of our supply chain and the introduction of new solutions in the marketplace to address the frequent worldwide medical isotope shortages is one of our foremost priorities as a company."

"As one of the top global producers of radioisotopes, NTP is pleased to enter into this mutual alliance with Lantheus Medical Imaging to ensure continued supply of Mo-99 for use in important diagnostic tests," said Don Robertson, managing director of NTP Radioisotopes. "For more than 17 years, NTP has played a significant role in its contribution towards the diagnosis and treatment of illnesses. We hold a world-class record for reliability in terms of delivery and quantity of radioisotopes, and strive to work with our partners to minimize any risks to the routine supply of Mo-99."

In other agreements/contracts news:

• Biotronik (Berlin), a company that makes wireless remote monitoring technology for patients with cardiac devices, has partnered with Belgian biotechnology company Cardio3 BioSciences in its C-Cure stem cell clinical trial. The trial is designed to evaluate the safety and efficacy of Cardio3 BioSciences' second-generation stem cell therapy in patients with heart failure. The first patient was treated in March.

Patients who participate in the trial will receive an implantable cardioverter defibrillator with Home Monitoring. These devices ensure optimal standard of care for patients with severe cardiac conditions, Biotronik said. According to the company, Biotronik Home Monitoring offers the most advanced remote monitoring for cardiac patients employing cellular technology in the third generation. The Home Monitoring system safely reduces the need for conventional in-office visits, while improving follow-up adherence, and enables earlier evaluation of clinically relevant cardiovascular events, the company said.

"This partnership with Cardio3 BioSciences highlights the quality of the Biotronik Home Monitoring system and also provides Biotronik with the opportunity to be directly involved in one of the most innovative areas of medicine. Longer term, what we learn through the trial will allow us to evaluate the potential to combine our innovative device technology with complementary approaches such as stem cell therapy so as to offer outstanding solutions to help to restore and secure the patient's quality of life in a lasting way," said Marlou Janssen, global VP of marketing and sales at Biotronik.

C-Cure is a second generation cell therapy for the treatment of heart failure that involves taking a patient's own stem cells from bone marrow and through a proprietary culturing technology generating differentiated cardiopoietic' cells which can regenerate damaged heart muscle. Unlike previous cell therapies for this indication, C-Cure is designed to produce new autologous heart muscle cells, which behave identically to those lost in infarction without carrying the risk of rejection, according to Cardio3.

In the two-phase, multi-center trial, 240 patients suffering from ischemic cardiomyopathy at 35 sites in eleven countries will be treated with C-Cure. The primary endpoint is a change in left-ventricular ejection fraction at six months post treatment.

• Guided Therapeutics (GT; Norcross) reported an agreement with Konica Minolta Opto (Tokyo) to co-develop non-invasive cancer detection products. The new development agreement follows two years of collaborative preparations to identify large market opportunities that would benefit from GT's technology, the company said.

The new products, for the detection of lung and esophageal cancer, are based on GT's LightTouch non-invasive cervical cancer detection technology, which is currently under FDA review for premarket approval.

GT says it is developing a rapid and painless test for the early detection of disease that leads to cervical cancer. The technology is designed to provide an objective result at the point of care thereby improving the management of cervical disease. Unlike Pap and HPV tests, the device does not require a painful tissue sample and results are known immediately, the company noted.

• RF Surgical Systems (Bellevue, Washington) and Medline Industries (Mundelein, Illinois) reported a new non-exclusive distribution agreement and have amicably resolved their legal dispute.

Medline will continue to distribute the RF Surgical Detection System to hospitals, surgery centers and other health care providers in the United States and Canada. Additionally, Medline and RF Surgical will expand their relationship to include Australia and New Zealand.

The FDA-approved RF Surgical Detection System scans for and signals an alert if any radio frequency-tagged sponges, gauze or towels remain in a patient prior to surgical closing procedures. Since the system was FDA approved over two years ago, all hospitals currently using this technology have eliminated the problem of retained surgical sponges/gauze in patients, according to the company.

• Alpine Biomed (Fountain Valley, California) reported an agreement with Given Imaging (Yoqneam, Israel) to enhance its gastrodiagnostic testing capabilities. The company's GastroTrac gastroenterology software suite will interface with Given Imaging's Bravo pH Monitoring System to provide doctors with a single system for their gastrointestinal testing needs.

Alpine will incorporate the Bravo pH software into a fully integrated version of GastroTrac with a comprehensive range of tests including catheter-based pH monitoring, upper and lower GI motility testing, electrogastrography and biofeedback. To simplify patient records, the Bravo pH software will share the GastroTrac database with the catheter-based pH monitoring studies. Alpine's VersaFlex pH catheters and the Bravo pH capsule are the only pH devices validated for use on the integrated GastroTrac system, the company noted.

• Agilent Technologies (Santa Clara, California) and Anderson Forschung Group (AFG; Washington) reported a collaboration to develop quantitative peptide assays to speed protein biomarker discovery and validation.

The collaboration will combine AFG's stable isotope standards and capture by anti-peptide antibodies (SISCAPA) technology with Agilent's 1200 Series HPLC-Chip and 6400 Series triple quadrupole mass spectrometers (MS), the companies said. The combination will be used to develop methods for measuring the amounts of large numbers of peptides in digests of complex samples such as plasma. The results will benefit both organizations, and financial details were not disclosed.

The SISCAPA method utilizes antibody-coated magnetic beads and a rotary magnetic bead trap device to capture target peptides, which are then measured using a nanoflow LC-MS/MS system. The goal is to accurately measure the quantities of very small amounts of peptides in sample digests, creating a useful research tool with potential uses in advanced diagnostics.

The Agilent 1200 Series HPLC-Chip/MS system is a microfluidic platform that integrates LC columns, connection capillaries, and nanospray emitter in a polymer chip, providing uncompromised chromatographic performance, even with small sample input amounts. The credit card-sized device is inserted into Agilent's HPLC-Chip Cube to interface with the MS. Chip loading, solvent and sample delivery, high pressure switching of flows, and chip positioning in the MS source are all automated.

The Agilent 6400 Series triple quadrupole LC/MS systems can provide femtogram-level sensitivity across a broad mass range. These instruments have earned a reputation for reliably quantitating trace organic compounds in complex matrices, such as drug metabolites, herbicide levels in food and contaminants in ground water.