BB&T Senior Staff Writer and Staff Reports

Wako Diagnostics (Richmond, Virginia) said it has received FDA 510(k) clearance to market its uTASWako i30 instrument with alpha-fetoprotein L3 (AFP-L3) and des-gamma-carboxy prothrombin (DCP) in vitro diagnostic (IVD) tests.

Peter Panfili, PhD, GM at Wako Diagnostics, said that the incidence of liver cancer in the U.S. is increasing in part because of its association with hepatitis B virus, alcohol use, obesity, and fatty liver disease. He added that the disease is typically diagnosed at a late stage when the prognosis is not very good.

“There is an absolute tragic short life expectancy after diagnosis for liver cancer if it's caught late,“ Panfili said. “The hope for physicians is better ways to diagnose the disease earlier. We believe this combination of these two proteins will contribute to this goal of earlier diagnosis and earlier recognition.“

The AFP-L3 and DCP assays are intended for use by healthcare professionals as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC), Wako noted. HCC, primary liver cancer, is currently the fastest growing cause of cancer-related death in the U.S., according to the company.

“Wako is very pleased to receive 510(k) clearance for these assays using microfluidic technology,“ Panfili said. “We expect that the adoption of these biomarkers into HCC surveillance programs will complement the use of imaging technologies to bring about the desired earlier detection and treatment of liver cancer.“

It has been demonstrated that HCC surveillance programs for at-risk patients improves applicability of curative therapies, Wako noted. Incorporating these biomarkers as additional surveillance tools will improve the chance of detecting early stage HCC and improve patient outcomes, the company said.

“There is a controversy in the medical community about surveillance,“ Panfili said. “The general agreement is that surveillance works, but getting compliance is a different matter.“ He noted that surveillance methods can be expensive and inconvenient for patients. Using blood-based biomarkers is a less expensive and much more convenient alternative.

“It's really a horrible disease and making physicians aware of the value of surveillance and that there are more tools . . . to help identify more cases of liver cancer earlier and that is going to save lives,“ Panfili said.

Microfluidics has enabled miniaturization and integration of key analyzer processes for the uTASWako i30: sampling, mixing, separation, and detection on microfluidic chips. The system uses immunochemical and electrophoretic techniques to achieve rapid, accurate, precise and sensitive assay results.

As a bench top automated instrument, the uTASWako i30 is designed for efficiency and ease of use in a clinical chemistry setting. Up to six analytes may be selected per patient sample with the first result reported in nine minutes. With automated calibration and quality control, the uTASWako i30 requires minimal setup time. Reagent usage is tracked using radio frequency identification tags.

Audrey Long, director of marketing for Wako Diagnostics, said the company expects to have the system available around May.

Wako is a division of Wako Chemicals USA (Richmond, Virginia) and a subsidiary of Wako Pure Chemicals (Osaka, Japan).

According to the company, the uTASWako i30 reports AFP-L3%, total AFP, and DCP values using Wako's unique reagents. Wako says it is the only company that offers 510(k)-cleared AFP-L3 and DCP assays for IVD use.

Elsewhere in the product pipeline:

• Affymetrix (Santa Clara, California) launched the GeneChip miRNA 2.0 Array. This enhanced version of its best-in-class microRNA (miRNA) interrogation solution is designed to support the research community's pursuit of personalized medicine by accelerating the identification of biomarkers and gene expression signatures associated with disease. Affymetrix claims this new GeneChip miRNA 2.0 Array offers the broadest coverage of known miRNA, encompassing 131 organisms on a single array, and nearly doubles the content of the previous array by updating the mature miRNA, small cajal body-specific RNA (scaRNA), and small nucleolar RNA (snoRNA). Moreover, it is the only array that contains unique probe sequences designed to independently interrogate human, mouse, and rat precursor RNA (pre-miRNA) and mature miRNA in the same experiment, which increases researchers' ability to get closer to biology by measuring changes in these key regulatory molecules.

• Ascom (Research Triangle Park, North Carolina) has introduced the ClinicalConneX/Cardiomax as its new integration suite powered by Ascom's Unite Professional Messaging and Alarm Application. Cardiomax is a component within the ClinicalConneX integration suite and provides an interface to Patient Monitoring Systems that forward alarm information to Ascom handsets or a wide variety of display devices, including pagers, mobile handsets and LED signs. It provides near real time alarms intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events captured by Patient Monitoring Systems. The display device can provide a combination of visual, audio and vibratory awareness mechanisms upon receipt of the secondary alert notification.

• Astra Tech (Waltham, Massachusetts) has launched an anatomically designed implant for sloped ridges called OsseoSpeed TX Profile. This implant eliminates the common compromise between marginal bone levels and esthetics in sloped alveolar ridge situations. The implant design meets a clinical need: it facilitates implant placement when there is a sloped ridge and optimizes implant position to maintain marginal bone support and esthetics. As with all Astra Tech dental implants, OsseoSpeed TX Profile has all the key features of the Astra Tech BioManagement Complex, inimitable and unique to the Astra Tech Implant System. Astra Tech, a company in the Astra Zeneca group, is a specialist in dental, surgical and urological products, services and support.

• Biotronik (Berlin) reported the European market launch of their new Renamic implantable cardiac device programmer. Renamic is the latest addition to Biotronik's new portfolio of external devices launched within only a few months. According to the company, its new user interface has been optimized with improved use of spacing and an intuitive color coding. The touchscreen can either be used with the stylet – or with any other tool, from fingers to ordinary pens. Besides being the smallest programming device in its class, Renamic features special compartments for accessories such as the power cord, so they can be stored within the device during transportation.

• Derma Sciences (Princeton, New Jersey) reported FDA clearance for the Medihoney Gel Wound and Burn Dressing. This latest Medihoney line extension is dispensed from a tube and is comprised of Active Manuka (Leptospermum) honey blended with natural-based gelling agents. The Medihoney product is a brand of honey-based dressings for the management of wounds and burns. The product has been shown to be effective in a variety of indications, and was the focus of a positive large-scale, randomized controlled trial involving 108 subjects with leg ulcers.

• GE Healthcare (Chalfont, UK) said the University of Colorado Hospital (UCH) has installed the new Carescape Monitor B850, the company's latest advance in bedside patient monitoring, to help enhance clinical decision making in the Neonatal Intensive Care Unit (NICU). The Carescape Monitor B850 enables access to critical patient information from any bedside monitor anywhere in the unit. Additionally, UCH leverages the Carescape Monitor B850 care area-specific monitoring features for more accurate NICU clinical measurements, and to help support its goal of aggressively addressing common premature infant complications.

• MELA Sciences (Irvington, New York) has filed an amendment to the MelaFind pre-market approval application with the FDA, limiting the indication for use to dermatologists. MelaFind is a non-invasive multi-spectral computer vision system designed to aid physicians in the detection of early melanoma from among clinically atypical (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 millimeters, evolving, patient concern, regression, and ugly duckling) cutaneous pigmented lesions that are non-ulcerated, not bleeding, and less than 2.2 centimeters in diameter, when a physician chooses to obtain additional information before making a final decision to biopsy to rule out melanoma. “We have clarified the intended use of MelaFind to dermatologists as a response to public statements made by several dermatologists sitting on the November 18, 2010 MelaFind FDA review panel,“ said Joseph Gulfo, MD, president/CEO. “We look forward to working with theagency to move the MelaFind PMA application forward. On a parallel track, we are seeking to obtain a CE mark for MelaFind from European regulatory authorities and hope to receive it in the second half of this year.“

• Miracor Medical Systems (Vienna, Austria) reported the completion of the pilot study of its PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) System, designed to improve acute coronary syndrome (ACS) revascularization following primary percutaneous coronary intervention (PCI). Timely myocardial reperfusion using primary PCI remains the most effective treatment strategy for limiting infarct size, reducing left ventricular remodeling, and improving clinical outcomes following ST-segment elevation myocardial infarction (STEMI). Miracor says its Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) system offers a new approach to improve microcirculatory flow, reduce myocardial injury and to revitalize ischemic myocardium. Initial clinical results show positive effects on MACE, restenosis rates, and long-term event-free survival. The PICSO system consists of the Miracor PICSO Impulse Console and the disposable, single-use Miracor PICSO Impulse Catheter. The Miracor PICSO Impulse System is CE-marked and can be used during coronary revascularization procedures following myocardial infarction and other types of acute coronary syndromes to intermittently increase the pressure in the coronary venous system.

• Neoprobe (Dublin, Ohio), a maker of oncology surgical and diagnostic products, reported results from a Phase II study of Lymphoseek (Tilmanocept) have been published online in the Annals of Surgical Oncology and demonstrate the tracing agent's ability to identify tumor-draining lymph nodes in breast cancer and melanoma patients. In the study, 78 patients underwent intraoperative lymphatic mapping with Lymphoseek injection to help identify tumor draining lymph nodes. For those who underwent lymphoscintigraphy, a tumor draining lymph node was identified in 94.5% of patients prior to surgery. Intraoperatively, Lymphoseek identified at least one regional lymph node in 96.2% of patients. The tissue specificity of Lymphoseek was 100% and displayed 95.1% mapping sensitivity by localizing in 173 out of 182 nodes removed during surgery. Lymphoseek is a radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure referred to as Intraoperative Lymphatic Mapping (ILM). If approved, Lymphoseek will be the first and only radio-labeled tracing agent specifically noted for ILM.

• OraSure Technologies (Bethlehem, Pennsylvania) and Roche (Basel, Switzerland) said the FDA has granted the companies 510(k) clearance on four homogeneous fully automated oral fluid drugs of abuse assays developed to be used exclusively as part of OraSure's Intercept Oral Fluid Drug Testing System. The cleared oral fluid assays include phencyclidine (PCP), cocaine, opiates and methamphetamine. The oral fluid assays use Roche's KIMS (kinetic interaction of micro-particles in solution) technology and were jointly developed under an agreement previously signed by the parties. These assays are designed to run on various clinical chemistry automated analyzers, which are intended to allow oral fluid samples to be processed with the same efficiency as current fully automated urine-based drug tests.

• PerkinElmer (Waltham, Massachusetts) has launched its new Signature precision panel prenatal diagnostic test for rapid testing of 15 common and severe chromosomal disorders. The Signature precision panel prenatal test is designed for pregnant women undergoing amniocentesis or CVS (chorionic villus sampling), who have been determined by their physicians to require specialized screening due to clinical or parental factors, such as maternal age. The test detects some of the most common and potentially severe chromosomal conditions that affect fetal health, allowing physicians to provide preliminary results to patients within one to two days of the sample receipt at the laboratory, followed by a comprehensive and confirmatory final report direct to physicians.

• Toshiba America Medical Systems (Tustin, California) has introduced the reNEW upgrade program, which provides customers the ability to upgrade throughout the entire suite of Toshiba's advanced Vantage 1.5T MR systems. As a cost-effective alternative to purchasing a new system, the reNEW program provides Toshiba Vantage customers multiple upgrade options, including upgrade paths to a Vantage Atlas or a Vantage Titan. Customers upgrading from the Vantage to the Vantage Atlas can take advantage of the advanced Atlas integrated coil technology and an extended field of view of 55 x 55 x 50 centimeters. The Atlas integrated coil system, which eliminates the need to reposition patients during exams by integrating the coils into the table, helps streamline exams and improve workflow creating a faster and more comfortable exam. For customers who upgrade from a Vantage or a Vantage Atlas to the Vantage Titan, the system's large open bore and 71-cm opening creates a more comfortable exam, which can help reduce claustrophobia in some patients. The Titan's large diameter can accommodate some bariatric patients.

• SynCardia (Tucson, Arizona) reported that Marcela Padilla became the first woman in the U.S. to leave the hospital using the Freedom portable driver to power her SynCardia temporary Total Artificial Heart. Padilla is participating in an FDA-approved IDE clinical study of the Freedom driver, the first U.S. portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital. Currently, the only FDA-approved driver for powering the Total Artificial Heart is the 418-lb “Big Blue“ hospital driver, which confines patients to the hospital until they receive a heart transplant. Padilla was implanted with the Total Artificial Heart on Sept. 24, 2010. Once stable, she was switched from the Big Blue driver to the Freedom portable driver. She and her family completed extensive training on use of the Freedom driver and in January, she was ready to leave the hospital to wait for a matching donor heart at home.

• Teleflex (Limerick, Pennsylvania) said its VasoNova subsidiary has FDA clearance to market the company's VPS peripherally inserted central catheter tip location technology as an alternative to chest X-ray or fluoroscopy in adult patients when the guidance indicator shows a blue bullseye. Currently, after most central venous catheters are placed, the correct location of the implanted catheter needs to be confirmed by chest x-ray, a process that is costly, time consuming, often repeated because of inaccuracy and which exposes the patient to radiation. VasoNova VPS is the first system to use a combination of hemodynamic and other biometric data to calculate precise tip location and to communicate the position to the user via a simple graphical interface. The system provides the clinician with the opportunity to place the catheter correctly the first time, avoiding the need for confirmatory chest x-ray where indicated. This provides benefits to the patient, the care-giver and the health care system as a whole.

• ViewRay (Cleveland) received federal regulatory clearance to begin commercializing its MRI-based technology to deliver radiation therapy to cancer patients. ViewRay says its technology helps doctors see exactly where radiation is being delivered to a cancer patient's body, unlike existing technology, which doesn't account for the movement of internal organs. That movement can cause radiation to be delivered to healthy issue, leading to harmful side effects. The company's technology aims to solve that problem by providing continuous soft-tissue imaging for more accurate delivery of radiation therapy. In August, the company raised a $20 million Series C round of investment.

• Ziehm Imaging (Nuremberg, Germany) has launched a new-generation of the Ziehm Vision RFD mobile C-arm. Offering what the company claims is outstanding imaging and a liquid cooling system which allows it to be used over an almost unlimited period of time, the new version is an attractive choice for hybrid ORs. Thanks to its mobility and significantly lower investment costs, the Ziehm Vision RFD hybrid edition is a reliable alternative to fixed installations in hybrid ORs, especially for hospitals with space and budgetary constraints. The hybrid edition features innovative flat-panel technology and delivers distortion-free images with over 16,000 shades of gray and a resolution of 1.5k x 1.5k pixels.