A Medical Device Daily
Iceland Genomics (IGC; Reykjavik, Iceland) and Roche Diagnostics (Basel, Switzerland) have entered into a cancer biomarker discovery collaboration aimed at developing diagnostic tests to predict recurrence of cancer.
The companies said they would jointly analyze patient samples to validate molecular markers for diagnostic tests to predict recurrence of cancer for selected tumor entities.
IGC said the agreement will give it access to certain gene expression data and support for further biological characterization of the patient samples in the company's BioBank in Iceland.
Financial terms of the agreement were not disclosed.
Dana Hosseini, CEO of the Iceland company, called the agreement "a significant opportunity for IGC. We look forward to working with Roche Diagnostics as a discovery partner to add significant value to our well-established BioBank and to further our knowledge of cancer."
Privately held Iceland Genomics said it uses a "clinical genomics" approach to understand the underlying mechanisms of cancer, isolate and characterize new therapeutic targets for cancer, assess the outcomes of specific therapies in genetically defined subcategories of cancer patients and optimize clinical trials.
The company was incorporated in Delaware in 1998. One of several genomics-based biotech companies operating in Iceland, it is the only one solely focused on cancer biology.
Laser gets nod in Japan
Candela (Wayland, Massachusetts) said it has received approval from the Japanese Ministry of Health and Welfare to sell its GentleYAG laser in that country. The device is used for hair removal, the treatment of vascular lesions including leg veins, and wrinkle reduction for all skin types.
Gerard Puorro, president and CEO, welcomed the approval, saying, "We will now be able to offer the most powerful Nd:YAG laser available to a broader range of potential customers in Japan, which is a significant opportunity given the effectiveness of this laser on darker skin types."
The GentleYAG is cleared for treatment of all skin types – even tanned skin, the company noted – and treats vascular lesions such as leg veins, wrinkles and unwanted hair. Candela said it is the "fastest and most powerful Nd:YAG laser on the market today."
GentleYAG targets the hair follicle to remove unwanted body hair quickly. The laser also reduces wrinkles and tightens skin by creating a thermal injury within the dermis, which "pushes" the wrinkle from the inside out.
Candela markets and services its products in about 65 countries and has an installed base of 8,000 lasers worldwide.
Three Asian distributors for EpiLift
VisiJet (Irvine, California), which does business as Advanced Refractive Technologies (ART), has signed agreements with three distributors to market and sell its EpiLift System in Japan, Thailand, Indonesia, Singapore, Malaysia and Brunei.
The EpiLift System, already approved for sale in Europe and the U.S., recently received approval for sale in Japan.
The system is the cornerstone of Epi-LASIK, a new version of the standard LASIK corrective vision surgery. Unlike LASIK, where a flap is cut in the epithelium, or top layer of the eye, Epi-LASIK creates a clean separation at a natural division point in the eye. The tissue is then lifted away from the cornea so that a laser can be applied to reshape it, and the eye regrows the connections with the epithelium, which the company said results in "a safer procedure with a significantly lower risk of complications such as dry eye or vision impairment."
The EpiLift system is manufactured in Germany by Gebauer Medizintechnik.
To access the Japanese market, VisiJet has entered into an agreement with Japan Focus (Tokyo), a distributor of medical products there since 1978. Supreme Products Co., described by VisiJet as "a prominent distributor of ophthalmic devices in Thailand," will sell the EpiLift System there. The company also has signed Ning Kwong Optical Co. to distribute the system in Singapore, Malaysia, Indonesia and Brunei.
CEO Randy Bailey said, "East Asia and Southeast Asia are important growth markets for a safe corrective vision surgical device. Our recent approval in Japan and our new distributorships give us solid footing as we ramp up our sales program in this region."
In addition to the EpiLift system, VisiJet is developing the HydroKeratome and Pulsatome, which use the company's waterjet technology in two other ophthalmic procedures – refractive and cataract surgery.
CALM system set for large facilities
LMS Medical Systems (Montreal), developer of the CALM (Computer Assisted Labor Management) system, has unveiled its foundation labor and delivery product suite for large-scale healthcare facilities.
The product was showcased at the annual conference of the Healthcare Information and Management Systems Society (Chicago) in Dallas.
LMS said the CALM product suite provides physicians, nurses and risk managers with decision support and risk management software that have been designed to create "a new standard of patient care and reduce risk in obstetrics." CALM 3.0 combines a clinical information system that includes advanced surveillance, archival and maternal-fetal charting with risk management tools that enable personalized labor evaluation, fetal monitoring and retrospective assessment.
Diane Cote, president and CEO of LMS, said, "Obstetrics remains an extremely complex area of medicine. The CALM 3.0 platform is the building block upon which we will be delivering interoperability and efficiencies that benefit both mothers and their babies."
Facility installation at hospitals that have ordered the product will begin in July, the company said.
MSI reports progress in China
Medical Services International (MSI; Edmonton, Alberta) reported that its China project, which has involved marketing the company's VScan HIV 1 & 2 Rapid Test Kit to various regulatory authorities in China, has reached operational status.
For the last two years the company has volunteered its VScan HIV 1 & 2 test kits to repeated government testing and regulatory scrutiny in China, with the end result, it said, being "an overwhelming approval by Chinese officials," which MSI attributed to VScan's "cost-effectiveness and its overall accuracy rating of 99.8%."
It was announced in January that the kits were to be utilized by nine blood bank facilities in China.
Chinese officials have granted MSI a contract to supply 10 provinces with 3.6 million VScan HIV 1 & 2 test kits per year for the next three years. That contract has a total value of $25.5 million, it said.
The company also has been asked by Chinese officials to submit its tuberculosis, Dengue fever, hepatitis B and malaria test kits for regulatory approval. Both the TB and hepatitis B test kits are being evaluated currently, MSI said.
The company said it is seeking approval for its kits in 19 additional countries worldwide.