BB&T Senior Staff Writer and Staff Reports

It's a scary thought, but according to Chembio Diagnostics (New York) CEO Larry Siebert, there are 1 . 1 million people in the U.S. infected with HIV and roughly 20% to 25% of them have no idea that they are infected. Chembio aims to make HIV testing easier, and faster through the development of its rapid point of care (POC) tests.

Siebert also told BioMedical Business & Technology that in 2006 the Centers for Disease Control (Atlanta) revised its estimate of new HIV cases annually to 65,000, “and that number has not really come down so any way that people can be tested is a good thing.“

Chembio makes rapid POC diagnostic tests for infectious diseases, including rapid HIV/AIDs tests. The tests are single test cartridges, similar to pregnancy tests, that use a small sample of blood and deliver a visual result in about 20 minutes, Siebert said. He also said the technology may someday serve as a viable at-home HIV test.

“Rapid HIV testing works by detecting antibodies against HIV, just like the kits used by healthcare workers for routine HIV testing,“ Siebert said.

Chembio received FDA premarket application approval in late 2006 to market two of its rapid HIV tests in the U.S. – the Clearview Complete HIV I and II, and Clearview HIV I and II stat pack. The company also is developing a new platform called the Dual Path Platform POC technology, Siebert said, which has generated a lot of new product opportunities.

These tests are CLIA-waved, Siebert noted, so “they're very simple to use.“ He said other CLIA-waved tests have made their way into the over-the-counter [OTC] market, but added that there is some controversy surrounding the ramifications of making HIV tests available at home.

If the FDA did decide to allow such tests to be sold over the counter, Siebert says Chembio has a couple of products that would potentially participate in that market. He said getting a product into the OTC market is like going after a second PMA because it needs to be tested in the hands of the intended consumers.

One product that might be a good candidate for the OTC market, Siebert said, is its Clearview Complete HIV I and II test. “It's a blood test, but it's very, very easy to use and it's a unique format,“ he said.

Another potential at-home HIV test candidate from Chembio might be its DPP HIV oral fluid test, Siebert said, but that test is not yet FDA approved. “We first have to get professional market approval for that,“ he noted. The company has already started clinical trials for that product in the U.S. for PMA approval, he added.

Another area Chembio is working on, Siebert said, is developing next generation tests for HIV. Those tests would include products that test not only for antibodies, but also for antigen, he said, which are known as fourth generation tests. Such testing might enable earlier diagnosis, Siebert said, which should lead to better outcomes.

Elsewhere in the products pipeline:

• AirStrip Technologies (San Antonio) received FDA clearance to market the AirStrip Remote Patient Monitoring solution (RPM), including AirStrip RPM Critcal Care and AirStrip RPM Cardiology. The AirStrip RPM solution allows clinicians remote access to critical patient data in virtual real time. Medical professionals will use their smartphones to see vital signs, critical waveform data and other clinical information, which is sent directly from the hospital and can be accessed from virtually anywhere a cell-phone or other wireless connection is available. Initially developed for the Apple iPhone operating system, the AirStrip RPM Critical Care and Cardiology solutions will now be available to medical professionals who use the iPhone 3GS and iPhone 4, iPod touch, and the iPad.

• Boston Scientific (Natick, Massachusetts) reported FDA approval of two spinal cord stimulation (SCS) leads for use with its Precision Plus Spinal Cord Stimulator System, the world's first rechargeable SCS device for the management of chronic pain of the trunk and/or limbs. The Linear 3-4 and Linear 3-6 Percutaneous Leads offer wider contact spacing to expand the lead choices available to physicians. SCS leads are designed to deliver electrical pulses from an implantable pulse generator to the spinal cord to mask pain signals to the brain. The new leads, in combination with the recently launched W4 and D4 lead splitters, provide the broadest range of percutaneous lead configurations in the industry, Boston Scientific said.

• Cardiovascular Systems (St. Paul, Minnesota) has launched the Diamondback Predator 360° PAD System, for the treatment of peripheral arterial disease (PAD). The new device uses the same mechanism of action as the Diamondback 360 PAD System with improvements in the crowns and shaft for enhanced clinical performance and shorter procedure times. The Diamondback Predator 360°, a minimally invasive catheter system, offers physicians a first-line therapy to quickly change lesion compliance, facilitate low-pressure balloon inflation, if desired, and achieve a smooth vessel lumen without placing a stent. With the Diamondback Predator 360°, physicians can now treat PAD more efficiently, achieving shorter procedure times and greater plaque reduction to address complex lesions located anywhere between the hip and toes, the company said. Both CSI PAD systems include a diamond-coated crown and unique orbital mechanism of action to remove hardened plaque to restore blood flow in arteries throughout the leg. The core technology of these systems is designed to avoid damage to blood vessels to possibly delay restenosis and foster better long-term patient outcomes.

• CA Wireless (Coral Springs, Florida) introduced the CellSafe Hospital Cell Phone Repeater Solution, which it says enables hospital staff, patients and visitors to safely use their phones while lowering or eliminating the risk to hospital equipment from electromagnetic interference. CA said data show that the proper application of wireless technology can increase productivity, decrease costs and improve the quality of healthcare within hospitals. Immediate access to patient data, test results and consulting physicians while the doctor is either on- or off-campus, or at the point-of-care, has the potential to save lives. Unlike traditional repeater systems that use coaxial cabling, CA said the CellSafe Hospital solution leverages the existing fiber optic infrastructure of a hospital to amplify the available cellular signal throughout the building. Given the large areas and spread out physical design of hospitals, coaxial cabling is an impractical and expensive solution for repeater systems. CA Wireless claims its technology can repeat a cellular signal up to a few kilometers with fiber with no signal loss, as opposed to only a couple of hundred meters with coaxial cable. By improving signal strength on cell phones, the resulting effect is a reduction in the need for cell phones to “power up“ for the wireless transmission.

• Endologix (Irvine, California) received FDA approval for its new PowerFit Aortic Extensions. The PowerFit extensions are designed to provide physicians with enhanced visibility under fluoroscopy to facilitate precise device placement during completion of the Anatomical Fixation endovascular repair of abdominal aortic aneurysm (AAA). PowerFit's independent stent design and 24 circumferential contact points were shown in anatomical simulation studies to aid in proximal conformability and sealing, the company said. PowerFit is designed for use with Endologix's existing products, including Powerlink main body bifurcated stent grafts and the IntuiTrak Endovascular System. It will be available in a range of sizes indicated to treat aortic necks ranging from 18 to 32 millimeters in diameter. In addition, the PowerFit product line will be available with longer stent lengths of up to 120 millimeters, to expand the treatment options for physicians and their patients.

• Entrada (Nashville, Tennessee) reported the availability of a software application for Apple mobile devices. The new eDictate application extends Entrada's automated clinical documentation process to the iPhone, iPod Touch and iPad, providing physicians with a powerful productivity tool that unlocks the potential of electronic medical records (EMRs). eDictate captures spoken medical reports on Apple handheld devices and securely transmits them to Entrada's web-based data center, where its voice recognition system automatically converts the recordings to text.

• MediPurpose (Norcross, Georgia) reported the launch of its latest safety medical product, the babyLance heel incision device for infants. A complement to the company's line of SurgiLance safety lancets, babyLance is designed to be a safe, easy and effective solution for newborn heel incisions. The babyLance will be available in two models: The babyLance Newborn (BLN), which delivers an incision depth of 1 mm. The babyLance Preemie (BLP), which delivers an incision depth of 0.85 mm.

• Microsulis Medical (Denmead, UK) has launched the Acculis percutaneous microwave tissue ablation system, Accu2i pMTA. Described by the company as a revolutionary new device for destroying tumors, the system is a 1.8 mm diameter closed water-cooled needle, with performance matching the existing Acculis open surgery MTA system. The device brings the benefits of microwave ablation into the realm of the interventional radiologist with applications in liver, lung, bone, kidney and appropriate other sites where local tumour control can be safely secured using volume ablation. The device is a single high power high frequency 2.45GHz microwave needle that can address tumours over 5 cm in size in just 6 minutes, and is therefore between 3 to 10 times faster than other systems, the company claims.

• ReSound (Minneapolis) has launched ReSound Alera, a wireless hearing aid. Operating on the 2.4 GHz frequency, ReSound Alera and the accompanying Unite wireless accessories introduce a new approach to the way a hearing aid receives sound from devices such as TVs, stereos, cell phones and computers. For the first time, the patient can receive sound directly from the device without cables, wires or the need to wear uncomfortable accessories. With Alera, the communication is wireless and direct – no strings attached, the company claims. ReSound goes on to say that because Alera uses 2.4 GHz wireless technology, it can be easily fitted without the use of a bulky device to connect the hearing aid to the fitting software. All that is needed is the AirLink fitting accessory, which is inserted into the USB port of a computer. This technology, though new to hearing aids, has been proven in the gaming industry and in the use of wireless keyboards.

• SeraCare Life Sciences (Milford, Massachusetts) has launched a set of new products in its diagnostic controls and panels portfolio – the SeraCare HIV-1 Seroconversion Panels. Each of the six panels consists of a set of undiluted plasma samples from a single plasma donor collected over a period of time during the development of detectable specific antibodies to HIV in the blood, or seroconversion, and is highly characterized with enhanced product information. SeraCare's HIV seroconversion panels can be used by customers to accelerate development of new test methods, provide a common reference for assay comparison and troubleshoot existing assays. SeraCare HIV-1 Seroconversion Panels are supplied with comprehensive test data vital for assay development and regulatory compliance, including results from twenty U.S. and international test methods for markers of HIV infection such as HIV RNA, 1st to 4th generation screening tests for HIV, confirmatory tests and a rapid discriminatory method.

• WaferGen Biosystems (Fremont, California) said it has launched the WaferGen SmartChip Real-Time PCR System, the next-generation Real-Time PCR system for discovery and validation of biomarkers, or gene expression patterns, on a single platform. “The launch of the full SmartChip System is a key milestone for WaferGen that signals the next step of SmartChip commercialization to expand on the success of our Early-Access Program and collaboration activities,“ said Alnoor Shivji, chairman/CEO. The SmartChip contains 5,184 nano-wells preloaded with target-specific primer pairs optimized for performance with the SmartChip System. MicroRNAs are small non-protein-coding single-stranded RNA molecules of 21-23 nucleotides in length that function as negative regulators of gene expression by targeting specific messenger RNAs.