BB&T Senior Staff Writer and Staff Reports

Molecular diagnostics company Clarient (Aliso Viejo, California) reported the commercial launch of Insight Dx Mammostrat, a new test designed to help quantify the likelihood of recurrence of breast cancer following surgery and initial treatment.

According to the company, the Mammostrat test employs an optimal set of five biomarkers that are able to be identified visually on a patient's tumor specimen by using a well-established technology called immunohistochemistry. Those biomarkers are then analyzed using a mathematical algorithm to generate an assessment of risk for cancer recurrence, Clarient said.

“It takes information from large-scale gene expression experiments and translates it . . . allows you to make sure that what you are testing is in fact the tumor as opposed to assays where you grind up the tumor,“ Rob Seitz, Senior VP of technology assessment at Clarient and one of the developers of the test said. In those other tests he mentioned, it can be difficult to know for sure if the test sample is the tumor or healthy tissue, he explained.

Seitz said the Mammostrat test also allows local pathologists to be able to view the images as well.

The company was awarded U.S. patent protection for the test earlier this year, just a couple months before GE Healthcare (Chalfont, UK) said it had agreed to acquire Clarient in a deal valued at $580 million That deal is expected to close late this year or early in 2011.

Mammostrat development was targeted to breast tumors which express estrogen receptor, the most commonly seen subtype of breast cancer, representing about 75% of the women diagnosed each year. The standard of care for most of these patients is surgery to remove the tumor, followed by anti-hormonal therapy. Mammostrat testing will help pathologists, oncologists and patients decide whether additional aggressive chemotherapy should be added to a patient's treatment regimen, the company said.

Mammostrat is well-validated, having been clinically studied on more than 3,000 women, as reported in multiple peer-reviewed journals, including Breast Cancer Research (Volume 12, 2010), Clinical Cancer Research (Volume 14, October 2006), and the Journal of Clinical Oncology (Volume 24, July 2008), Clarient noted. Data from Mammostrat trials have also been presented at national conferences, including the American Society of Clinical Oncology (Alexandria, Virginia) meeting in Chicago and the San Antonio Breast Cancer Symposium.

Clarient says that by using the Mammostrat test pathologists, oncologists and patients can gain greater understanding of the aggressiveness of a patient's disease and guide clinical management. Mammostrat provides additional clinical information that cannot be obtained from routinely used prognostic factors. The Mammostrat test can be performed on small biopsy samples, and results are typically delivered in as little as 48-72 hours, thereby allowing more rapid treatment decisions.

“Mammostrat can be an important tool for clinicians assessing the aggressiveness of their patient's breast cancer,“ said Ron Andrews, CEO and vice chairman of Clarient. “Mammostrat results can provide clinicians important information to help select the appropriate therapeutic management for each individual patient. For patients, Mammostrat offers the confidence that the decisions being made to manage their breast cancer are based on the clinical characteristics of their specific disease using the most current validated technology available.“

Clarient says it is in coverage determination discussions with both government and private insurance carriers.

“Mammostrat fits well within the combined Clarient goals of bringing value to both the patient and to the healthcare system,“ Andrews said. “The test provides validated information more rapidly than other tests currently available, which may allow for treatment to begin earlier in the course of the disease.“

Clarient's customers are connected to its Internet-based portal, PATHSiTE, that delivers high resolution images and critical interpretive reports based on our diagnostic testing. Clarient also develops new “companion“ diagnostic markers for therapeutics in breast, prostate, lung, ovarian, and colon cancers, and leukemia/lymphoma.

Elsewhere in the product pipeline:

• Arterial Remodeling Technologies (ART; Paris) disclosed new data related to its bioresorbable stent platform – additional data that it says further validates the company's innovative approach to simultaneously balance biocompatibility, biomechanics and bioresorption within a bioresorbable PLA (polylactic acid) stent. The new data show that the ART stent scaffold can be overinflated by more than 25% without cracking or crazing, and is thus designed to avoid the serious problem of malapposition associated with other bioresorbable stents that was documented at TCT 2010. ART claims its stent is designed to have several competitive benefits over existing bioresorbable stents in development: (1) faster and smoother resorption; (2) a non-crystalline polymer; (3) superior preserved material, without harmful by-products; (4) better, homogeneous stress diffusion; and (5) crack- and crazing-free expansion. In addition, the ART device is designed to be delivered by conventional stenting techniques, is balloon-expandable and meets the market standard of 6-French compatibility.

• AtriCure (West Chester, Ohio) reported initial patient enrollment in its DEEP AF feasibility trial. The trial is designed to evaluate the safety and efficacy of a dual epicardial/endocardial procedure (DEEP), or hybrid procedure, to treat atrial fibrillation patients with persistent and long-standing persistent atrial fibrillation (AF). The hybrid procedure combines the benefits of both minimally invasive surgical ablation and catheter ablation and mapping techniques, leveraging the skills and technologies of both the cardiac surgeon and the electrophysiologist. The DEEP AF trial uses AtriCure's minimally invasive surgical ablation product platform in conjunction with the Biosense Webster Thermocool catheter ablation products.

• BG Medicine (Waltham, Massachusetts) received FDA approval for the Galectin-3 test for use in conjunction with clinical evaluation as an aid to assess the prognosis of patients diagnosed with chronic heart failure. Galectin-3 is a protein that has been shown to play an important role in the development and progression of heart failure in approximately 30% of the patients diagnosed with heart failure. This galectin-3 mediated form of heart failure is associated with progressive fibrosis, or stiffening, in the heart muscle, which impairs the heart's ability to pump. The role of galectin-3 in heart failure was first established in 2004, and the clearance of the company's Galectin-3 blood test now for the first time allows physicians to use this product in the evaluation of patients diagnosed with heart failure. The BGM Galectin-3 test is based on the common ELISA format using the standard microtiter plate presentation.

• Biomagnetics Diagnostics (San Francisco) reported that an updated prototype bench top version of the Integrated Optical Biosensor, originally developed at Los Alamos for research purposes, is now complete. Along with the updated instrument an entirely new software interface to operate it has been successfully coded and integrated. The new instrument is currently being validated for performance using well characterized biological assays. The company says this is a significant milestone in the cooperative research agreement that was signed between Los Alamos National Laboratory and Biomagnetics, representing a major step in the development of a new point-of-care diagnostic system. Biomagnetics Diagnostics makes diagnostic systems and technology for HIV, hepatitis, tuberculosis, cholera and malaria detection.

• Boston Scientific (Natick, Massachusetts) welcomed the publication of an analysis from its ALTITUDE Clinical Science program in the current issue of Circulation that showed patients followed by the Latitude Patient Management system experienced a 50% relative reduction in the risk of death compared to patients followed in-clinic only. The analysis also showed that heart failure patients who transmitted weight and blood pressure data via the Latitude system experienced an additional 10%reduction in the risk of death compared to other CRT-D patients followed by the Latitude system.

• Conmed (Utica, New York) received FDA clearance for the company's thermal energy-based tissue fusion system for use in a wide range of surgical procedures. Over the last several years, surgeons have expanded the use of energy based instruments to reduce surgical times, improve patient outcomes and decrease procedure costs. Based on Conmed's original research in the technology, and with the understanding of surgeon needs, Conmed has developed the Altrus Thermal Tissue Fusion system to advance the performance of energy-based instrumentation. Using thermal energy, the Altrus System is a multi-functional surgical tool that seals, cuts, grasps, and dissects vessels up to 7 mm in size using a closed feedback loop between the energy source and the single-use handpiece to precisely control the desired effect on tissue.

• CSL Behring (King of Prussia, Pennsylvania) reported the availability of the HeliTrax system as part of a specially designed software platform for Apple's iPhone, iPod touch, or iPad devices. This enhanced system is designed to improve therapy management for people with hemophilia A who use CSL Behring's recombinant factor VIII (rFVIII). The HeliTrax software is designed with an interface that ensures compatibility with both Lab Tracker and WebTracker patient management systems used by hemophilia treatment centers throughout the U.S. This software automatically transmits patient information to the hemophilia treatment centers, making disorder management easier for both users and staff, the company said. The HeliTrax system is now available through CSL Behring on an iPhone as well as via download through Apple's App Store.

• DePuy Spine (Raynham, Massachusetts) reported the launch of the Mountaineer Laminoplasty System of implants and instruments for posterior decompression of the cervical spine. The system is intended for se in the lower cervical and upper thoracic spine (C3 to T3). The Mountaineer has a “dove-tail feature“ on the plate that allows for a secure, flush fit attachment to the instruments. Notches on the allograft provide secure attachment points and tabs prevent the holder from migrating into the canal. Another feature is the open ended plate that allows for both a traditional and a “screw-first technique,“ where the lamina screws may be inserted prior to creating the hinge. Finally, the system offers three different plate options including inline, inline side-by-side and hinge. Allograft spacers are designed to fit the anatomy and attach to multiple plate sizes.

• Guided Therapeutics (Norcross, Georgia) received FDA notification that the company's PMA for the LightTouch Cervical Scanner is suitable for filing. The LightTouch, which consists of a base unit and single-patient-use calibration disposable, scans the cervix with light to identify cancer and pre-cancer painlessly and non-invasively. Guided Therapeutics' biophotonic technology is able to distinguish between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require laboratory analysis or a tissue sample, is designed to provide results immediately and eliminate costly unnecessary testing.

• IDEV Technologies (Webster, Texas) reported the first procedure in the U.S. using the Supera Veritas transhepatic biliary system, which was recently cleared to market by the FDA. The Supera wire interwoven nitinol stent is cleared for palliative treatment of biliary strictures produced by malignant neoplasms. Biliary strictures involve a narrowing of the bile duct, the body's transportation system for fluid that is an essential aid to the digestion of food. Stents are commonly used to reopen the bile duct and restore the natural flow of fluids. Full commercial launch of the Supera Veritas Transhepatic Biliary system is planned for 1Q11.

• Lantheus Medical Imaging (N. Billerica, Massachusetts) reported the first commercial production of TechneLite (Technetium Tc99m Generator) generators using molybdenum-99 (Mo-99) produced with low-enriched uranium (LEU) targets, making Lantheus the first company to use Mo-99 sourced from LEU in the U.S. Mo-99 is the parent isotope of technetium-99m (Tc-99m), the most widely used radioisotope in the world for molecular and nuclear diagnostic imaging tests. Tc-99m is a critical component of many medical tests, including scans of the heart, brain, kidneys and some types of tumors. Tc-99m is used in Lantheus Medical Imaging's TechneLite generators, which are distributed to hospitals and radiopharmacies as a source of Tc-99m for diagnostic imaging procedures.

• MedPro Safety Products (Lexington, Kentucky) said that its passive safety winged blood collection set has received FDA clearance. The passive safety winged blood collection set, commonly referred to as a 'butterfly' collection and infusion device, is the first collection set with a passive safety feature that activates through normal occupational use and without an extra procedural step. The needle becomes fully encapsulated as it is removed from the patient, thus reducing the risk of a needlestick injury. It can also be used as a single patient infusion set, allowing for venous access for blood collection in addition to infusion procedures. It features a familiar look and feel for the healthcare worker, the company said.

• Mindray Medical (Mahwah, New Jersey) introduced the Mindray V Series patient monitoring system, a scalable platform that focuses on the clarity and continuity of data at a single point of care. Mindray says the V Series solution is the result of research focused on identifying the unique challenges of critical care and other high acuity environments. The V Series has been conceived, tested and proven in a true environment by the end-users who understand the complexities and workflows. It addresses the need for more effective care without information overload and unnecessary alarms; it simply focuses on the most critical information.

• OrbusNeich's (Hong Kong) Genous Stent shows favorable outcomes compared to bare metal stents (BMS) for the treatment of coronary artery bifurcation lesions, according to data published online in the journal Atherosclerosis. Genous is OrbusNeich's endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that attracts EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis. The company says there is a growing body of evidence from multiple clinical studies that the Genous Stent is effective for patients who are non-responsive to or cannot tolerate long-term dual antiplatelet therapy.

• St. Jude Medical (St. Paul, Minnesota) reported two-year results in a post-market clinical study evaluating neurostimulation (spinal cord stimulation) for the management of chronic low back pain. The study found that 70% of neurostimulation patients reported overall pain relief of 50% or better at their final two-year visit. Additionally, 88% of these patients reported that their quality of life was improved or greatly improved. The study design uses the Eon rechargeable spinal cord stimulator and dual or tripolar arrays of percutaneous leads or surgical leads.

• Systagenix (London) reported the launch of Adaptic Touch Non-Adhering Silicone Dressing: a new primary silicone wound contact layer comprised of a cellulose acetate mesh coated with a soft tack silicone. Paolo Di Vincenzo, Systagenix VP of marketing, said: “This is a contact layer that addresses the needs of both patients and healthcare professionals by protecting the wound, having maximum conformability, staying in place, being easy to remove, and minimizing tissue damage and adherence to the secondary dressing.“

• Wright Medical Group (Arlington, Texas) reported the limited release of the PRO-TOE VO Hammertoe Fixation System. This product introduction is designed for patients requiring fusion of the lesser toes for hammertoe deformities. A hammertoe is a deformity of the tissues surrounding the bony structures of the lesser toes. The patient's toes elevate and cause discomfort while wearing shoes. Designed by foot and ankle surgeons, the PRO-TOE VO Hammertoe system is an efficient surgical solution for fixation of the bones being corrected. Robert Anderson, MD, of OrthoCarolina in Charlotte, North Carolina said, “The PRO-TOE VO Hammertoe system provides a simple and economical solution for my patients with hammertoe deformities. The system offers solid fixation on both sides of the joint and the unique geometry allows for it to be precisely repositioned during surgery to provide the best clinical outcomes for the patient.“

• X-spine (Miamisburg, Ohio) reported FDA clearance of its new Axle interspinous fusion system. The system is designed to provide spinal stability for lumbar fusion procedures, including the treatment of degenerative disk disease, spinal tumors and trauma. The Axle system uses a modular design to allow for implant customization to conform to individual patient anatomy. The implant can be placed through a one inch incision in the back with minimal disruption of tissue. The device works by rigidly attaching to the rearmost portion of adjacent vertebrae, termed the spinous process, of the lower or middle spine.