BB&Ts

During flu season, catching the flu is about as easy as counting to three, and a new device from 3M (St. Paul, Minnesota) may make detecting the highly contagious viral respiratory infection just as easy.

3M has reported nationwide availability of its 3M Rapid Detection Flu A+B test. According to 3M, it is the first rapid flu test to provide automated results. The automated technology helps reduce user interpretation errors, which can lead to both false negative or false positive results, the company said. The 3M Rapid Detection Flu A+B test will be able to deliver hospital and physician office laboratories "reliable and objective" electronic results in 15 minutes, 3M noted.

"Bringing automation to the interpretation of influenza tests is a key factor for the next generation of rapid flu tests," said Brian Anderson, marketing manager, 3M Health Care. "Automating and storing the objective result of a flu test will help increase laboratory productivity and minimize the potential for human error, which can contribute to improving patient outcomes."

Anderson told Biomedical Business & Technology that the new flu test is a lateral flow immunoassay with the same core technology as other rapid flu tests on the market, except that the new test uses a small instrument – the 3M Rapid Detection Reader – that actually interprets the test results. All other rapid flu tests are visual read tests, like a pregnancy test, he said, with a blue or red line and the laboratory technician interprets the results visually.

With traditional lateral flow tests, the lab technician has to set a timer and go back and read the results, Anderson said. "A lot of times in a busy laboratory that can be a challenge. Technicians are spread thin ... it's not unusual to get sidetracked and be late in reading a test result," he said.

Requiring less than three minutes of prep time, 3M says its flu test is designed to detect positive or negative results, and differentiate influenza A and influenza B with results clearly displayed on the reader.

The technology also is intended to enable labs to export data through laboratory information systems, further reducing the potential for reporting error by eliminating the need for manual recording and transferring of patient results. The test also reads and stores lab results, giving lab technicians more flexibility in time and test management, 3M said.

"In the flu season hospitals are inundated with tests, especially at the peak of flu season, because of needing to time the results and interpret the results, this system really automates and simplifies the running of the assay," Anderson said.

He said influenza diagnostics is estimated to be more than a $100 million market and is "growing very rapidly."

The 3M Rapid Detection Flu A+B test uses the RAMP technology platform from Response Biomedical (Vancouver, British Columbia). In late 2006 the two companies formed a collaboration to sell rapid infectious disease tests worldwide. The Flu A+B test is the first product to come out of that agreement.

Elsewhere in the product pipeline:

• Accelr8 Technology (Denver) said research investigators at the Denver Health Medical Center have presented results of a study using the company's BACcel rapid diagnostic system. The purpose of the study was to estimate the potential impact of rapid diagnosis on reducing the use of suboptimal and inactive therapy caused by delays in obtaining results from standard lab cultures. The investigators analyzed stored isolates using a prototype BACcel system, measuring the test's accuracy and speed in classifying MRSA and susceptible strains in the isolates that caused the original infections. They found the BACcel identification test had 100% sensitivity and 89% specificity in identifying MRSA within four hours of analysis of the isolates.

• AngioDynamics (Queensbury, New York) said it will launch a new varicose vein therapy brand, VenaCure EVLT, at the American College of Phlebology annual congress. The new brand will encompass the best of AngioDynamics' VenaCure product line as well as EVLT, a product line which AngioDynamics recently acquired from Diomed. "As the name conveys, our new brand will be everything you liked about VenaCure and EVLT in one package," said Sean Morris, senior VP/GM of AngioDynamics' peripheral vascular division. "We have now combined the best of Diomed and AngioDynamics into a dream team offering for physicians and their patients. Patients get an effective, outpatient alternative to otherwise painful and invasive surgery. Physicians get continuous support from AngioDynamics to develop their clinical practices and provide patients with the best treatment available."

• Aurora Imaging Technology (North Andover, Massachusetts) said the Aurora 1.5 Tesla dedicated breast MRI system has received FDA clearance for AuroraSpectroscopy, the company's breast magnetic resonance (MR) spectroscopy package. The availability of AuroraSpectroscopy will provide Aurora Breast MRI the capability to perform in vivo breast MR spectroscopy (MRS) and MR spectroscopic imaging (MRSI). AuroraSpectroscopy was developed to supplement Aurora breast MRI by further improving the image specificity of this groundbreaking technology. The Aurora breast MRI remains the only FDA-cleared dedicated breast MRI system specifically designed for the detection, diagnosis and management of breast disease alone.

• Baxa (Englewood, Colorado) reported the laun-ch of an interactive training capability, referred to as the Virtual Compounder, which enhances its existing Web-based training tool for sterile compounding education. The Virtual Compounder is a series of training lessons that allows users not only to read and memorize materials, but to demonstrate a clear understanding and proficiency in the concepts. This new interactive training tool has been incorporated into the CriticalPoint training program. Through the Virtual Compounder, users are required to walk through a hands-on training session on their desktop. Its step-by-step lessons help ensure safe compounding practices, thereby improving patient safety. The addition of this specialized interactive component to the existing CriticalPoint training strengthens user retention and enhances the overall user experience.

• Bovie Medical (Melville, New York) received FDA clearance to market its ICON GP generator to be used in general surgery and in conjunction with Bovie's Polarian vessel-sealing instruments. A 510(k) application has not yet been filed for the Polarian instruments.

• BSD Medical (Salt Lake City) said that an article titled "Neoadjuvant Treatment of Locally Advan-ced Soft Tissue Sarcoma of the Limbs: Which Treatment to Choose?" was published in The Oncologist.The article reviewed different cancer treatment regimens for treating soft-tissue sarcoma, including adding hyperthermia to chemotherapy, a combination that "boosted'" local progression-free survival for sarcoma patients, according to the authors. The study results had demonstrated an approximate doubling of disease-free survival time for patients who received treatments using the BSD-2000 system to deliver hyperthermia in combination with chemotherapy, surgery and radiation, as compared to those patients who received chemotherapy, surgery and radiation alone. The publication of the results from this major study has caused a review of the methods used for preoperative treatment of soft-tissue sarcomas. The aim of preoperative treatment for soft-tissue sarcoma is to "downstage" the sarcoma prior to surgery, resulting in subsequent limb salvage and better local tumor control by making the tumor smaller.

• Cardo Medical (Los Angeles) reported FDA clearance of its Align 360 total knee system. The system is the flagship product within the company's Align 360 platform, which has already received FDA clearance for its Uni-Compartmental and Patello-Femoral systems. All three systems feature a unique modular approach and common instrumentation system with a revolutionary concept designed to deliver simplified, reproducible surgical outcomes. Cardo Medical's Uni-Compartmental System, which was the first product release within the Align 360 platform, has been used in more than 500 surgeries to date.

• Cardiac Science (Bothell, Washington) reported the launch of the fourth generation of Burdick HeartStride exercise stress systems. This new version adds echo and nuclear systems connectivity to the existing connectivity with EMR/other systems. "With the connection to echocardiography and nuclear devices," said René Mitchell, Cardiac Science director of diagnostic marketing, "HeartStride allows the stress and imaging systems to use the same ECG signal. That's significant. Now the systems base their assessments off the same tracing."

• Cepheid (Sunnyvale, California) said the FDA has categorized Cepheid's Xpert MRSA/SA Blood Culture (BC) test as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments (CLIA). The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus in positive patient blood culture bottles. The test runs on Cepheid's GeneXpert system, the leading platform for on-demand detection of Healthcare Acquired Infections. The GeneXpert system is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert combines on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples.

• Cook Medical (Bloomington, Indiana) reported the availability of the Ciaglia Blue Dolphin balloon percutaneous tracheostomy introducer, the first device for percutaneous dilational tracheostomy (PDT) procedures that combines balloon dilation and tracheal tube insertion into one step. PDT is an elective procedure generally performed on patients in the ICU who require long-term ventilation. PDT is accepted as a safe, cost-effective and reliable bedside procedure, but Cook noted that patients still are at risk for intraoperative complications, including tracheal trauma. The balloon minimizes pressure on the anterior tracheal wall and delivers an even and controlled radial dilation. This significantly reduces the downward force needed to create a tracheal stoma compared to traditional PDTs, according to the company. Featuring a nylon construction, the Ciaglia Blue Dolphin balloon measures 5.4 cm long, with an outer diameter of 16 mm when fully inflated. The maximum inflation pressure of the balloon is 11 atmospheres.

• CoolTouch (Roseville, California) has introduced the CoolLipo Trio, which allows physicians to perform laser-assisted lipolysis and skin tightening with CoolLipo, endovenous ablation with CTEV and non-ablative skin rejuvenation with CoolBreeze, all in one laser system. The CoolLipo Trio system is based on CoolTouch's signature 1320 nm wavelength, a wavelength that the company said has a proven track record for fat ablation, dermal collagen regeneration and endovenous ablation of varicose veins. The CoolLipo Trio's first and foremost modality is the CoolLipo procedure for laser-assisted lipolysis and skin tightening, which is used widely to sculpt small areas of the body such as the neck, jowls, chin, and saddlebags, or to tighten a loose belly. CoolLipo can be used in conjunction with larger liposuction cases by using the CoolBlue Duet, the only handpiece on the market that lases and aspirates simultaneously, reducing procedure time and providing tighter skin more efficiently.

• Ellex Medical Lasers (Adelaide, Australia) said it will preview a new, multi-color photocoagulation laser, Integre Pro, at the American Academy of Ophthalmology meeting in Atlanta. The Integre Pro combines two optimal wavelengths and high power not previously available in photocoagulators – 1.5 watts of 561 nm yellow wavelength and 1 watt of 670 nm red – permits the full treatment range of three-wavelength photocoagulators, displacing the need for green wavelengths. Compared to traditional 514/532 nm green wavelengths, the Integre Pro's 561 nm yellow wavelength creates a more gentle retinal burn and results in low scotoma formation. This, in turn, provides for better control over the interaction between laser beam and tissue. The yellow wavelength is not absorbed by xanthophyll, which makes it ideal for treatments in and around the macula. It also produces less scatter, which creates superior transmission through existing opacities, including cataracts. The high power permits iridotomies and laser trabeculoplasties.

• Gambro (Denver) said it is introducing what it calls "the latest innovation in dialyzer technology" – Polyflux Revaclear and Polyflux Revaclear MAX. The Polyflux Revaclear dialyzers feature a membrane technology and an advanced design, which combine to deliver outstanding clinical performance for treatment of dialysis patients. The high-flux dialyzers feature a new membrane that Gambro said is more efficient and more selective while retaining the same proven 3-layer membrane structure as the existing Polyflux dialyzer. The membrane is composed of a unique blend of the polymers PAES (Polyarylethersulfone) and PVP (Polyvinylpyrrolidone).

• Honda Motor Co. (Tokyo) has unveiled its second experimental walking assist device that helps support body weight to reduce the load on an individual's legs while walking, going up and down stairs, and in a semi-crouching position. The device is designed for people who are capable of walking and maneuvering on their own, but who can benefit from additional leg and body support while performing tasks. Honda will begin testing the device in real-world conditions to evaluate its effectiveness. The new walking assist device with the body weight support system reduces the load on leg muscles and joints (in the hip, knees, and ankles) by supporting a portion of the person's body weight. The device has a structure consisting of seat, frame and shoes, and the individual can put it on by simply wearing shoes and lifting the seat into position.

• LifeNet Health (Virginia Beach, Virginia) said it has received FDA clearance for CardioGraft allograft cardiac patch products with MatrACELL decellularization technology. LifeNet Health received clearance for the technology for cardiac products, which safely removes donor cells from cardiovascular tissues while retaining the native biomechanical strength of the tissue.

• Medtronic (Minneapolis) said that new 24-month data from a study published in the scientific journal, Neurosurgery, show that spinal cord stimulation (neurostimulation therapy) provides sustained, significant improvement in otherwise intractable, chronic leg pain, quality of life and functional capacity out to 24 months of therapy. Supported by Medtronic, this neurostimulation study followed patients with chronic neuropathic leg and back pain who received spinal cord stimulation therapy along with conventional medical management to compare the results to patients who received conventional medical management alone. The results showed that positive results are sustained in patients who received Medtronic neurostimulation therapy plus conventional treatments at 24 months. Spinal cord stimulation therapy uses an implantable medical device similar to a pacemaker to deliver electrical pulses to the epidural space in order to interrupt pain signals traveling through the nervous system from reaching the brain.

• Nonin Medical (Minneapolis) demonstrated the first Continua pre-certified pulse oximeter at the 5th annual Connected Health Symposium in Boston. Nonin said it collaborated with other companies in recent months to successfully complete the international connectivity standard for the interoperability of pulse oximeters, ISO/IEEE 11073-10404. "This is a significant step toward eliminating proprietary interfaces, allowing pulse oximetry equipment to communicate freely with other devices," said Kurt Kermes, standards architect at Nonin Medical.

• OraSure Technologies (Bethlehem, Pennsylvania) has submitted a pre-market approval (PMA) application to the FDA for what will be the first rapid test for antibodies to the HCV. If approved, the OraQuick HCV test is expected to be the first rapid HCV test approved for use in the U.S. OraSure is seeking approval for use of its OraQuick HCV test on five specimen types, including oral fluid, fingerstick whole blood, venous whole blood, plasma and serum. The submission reflects the successful completion of clinical studies which include data from over 3,000 subjects. The company also will seek CE-mark approval for commercialization in the European Union within the next few months. OraSure also said it will begin to sell its OraQuick Advance Rapid HIV-1/2 Antibody Test directly into the U.S. hospital market beginning in 2009. In recent years, the U.S. hospital market has received this product through an exclusive distribution arrangement with Abbott (Abbott Park, Illinois). The company says the OraQuick Advance is the only rapid, point-of-care test for the detection of antibodies to both HIV-1 and HIV-2 within 20 minutes that is approved by the FDA for use on oral fluid, finger-stick or venipuncture whole blood, and plasma specimens. The test is CLIA-waived for all specimen types except plasma.

• Osmetech (London) reported the launch of a genetic test for CYP450 2C9 drug metabolism. CYP450 2C9, or CYP2C9, is a member of the Cytochrome P450 family of enzymes responsible for detoxifying potentially hazardous chemicals, such as drugs, that are "foreign" to the body. CYP2C9 polymorphisms result in a decrease or loss of enzyme activity, which can influence the appropriate dosage of the prescribed drug. The CYP2C9 test is important in optimizing the dosage of drugs or the selection of alternative drugs. Moreover, during the development of new drugs metabolized by CYP2C9, genetic tests assist in the appropriate selection of patients for clinical trials and the optimization of dosage for those patients based on their ability to metabolize the drug.

• Revolutions Medical (Mount Pleasant, South Carolina) filed a 510(k) application with FDA for its 3 cc Rev Vac Safety Syringe. The Rev Vac safety syringe uses technology to draw the needle into the syringe chamber after use. This safety syringe should result in a major decrease in accidental needle stick injuries. Another safety feature is that it will disallow the reuse of the syringe. This may decrease the spread of HIV and other blood-borne diseases. This safety syringe is used one-handed, an important feature for medical personnel.

• Roche Molecular Diagnostics (Pleasanton, California) said the FDA has approved the COBAS AmpliPrep/COBAS TaqMan HCV Test for use in the U.S. The test uses Roche's real-time PCR (polymerase chain reaction) technology to quantify the amount of hepatitis C RNA in a patient's blood. Physicians use hepatitis C viral load testing results to establish a baseline level of hepatitis C infection and to serially monitor viral load levels and treatment effectiveness in patients on therapy. The test is designed for use on the first fully automated, FDA-approved, real-time PCR platform, providing sample-in/results-out capability. The system menu includes an FDA-approved HIV viral load test, with continuous loading of samples in addition to parallel processing of HIV and HCV tests.

• Sanarus Medical (Pleasanton, California) said the American College of Surgeons Oncology Group, which just initiated a National Cancer Institute-funded Phase II clinical trial exploring the use of cryoablation therapy in the treatment of invasive breast carcinoma, has selected the Visica 2 treatment system from Sanarus as the exclusive technology to be used in the cryoablation portion of the study. The Sanarus Visica System has predominately been used in the cryoablation of non-cancerous tumors called fibroadenomas since its initial FDA market clearance in March 2002. This office-based procedure, which usually takes less than 20 minutes, involves placing a small needle into the center of the tumor using ultrasound guidance and subsequently freezing and killing the tumor. Sanarus said the safety and efficacy of cryoablation have been well established in more than 2,000 fibroadenomas that have been treated with the system to date.

• Sequenom (San Diego) reported the launch of an independent, prospective, multi-center observational study to document the performance of the company's SEQureDx Trisomy 21 technology for Down syndrome based upon Sequenom's SEQureDx technology. The study's primary goal is to document the performance (clinical sensitivity and false-positive rate) of Sequenom's T21 technology that uses fetal RNA in maternal plasma to identify Down syndrome in early pregnancy. The study has a secondary goal of developing a bank of samples to aid in improving SEQureDx T21 detectability in the identification of other chromosomal abnormalities.

• Siemens Hearing Instruments (Piscataway, New Jersey) has introduced its Motion line of hearing instruments. Motion includes the Siemens feedback reduction algorithm, advanced localization, automatic learning, and speech and noise management system, so even in complex listening environments there is no need to change programs or adjust volume settings. Plus, it is available with optional Tek Bluetooth wireless enhancement with Tek connect remote control that streams music, phone calls, and TV audio to the hearing instruments in full stereo sound. Motion is available with algorithms such as SoundLearning and DataLearning that remember sound quality and volume settings, and eWindScreen that continually analyzes incoming signals to detect wind noise, then automatically adjusts signal processing to reduce it.