Luminex (Austin, Texas) reported that it has received FDA 510(k) clearance for a new cystic fibrosis (CF) test: the xTAG Cystic Fibrosis 39 Kit v2, which is designed to detect the 39 CF-causing gene mutations. It is used to screen potential parents to determine if they are carriers of CF mutations, as an aid in newborn screening and in confirmatory diagnostic testing in newborns and children.
This test is actually a new, improved version for Luminex. The first iteration was cleared by the FDA in 2005.
"Compared to the previous version, this is faster and requires less labor," Jeremy Bridge-Cook, PhD, senior VP, Assay Group at Luminex, told Biomedical Business & Technology. "The previous version took about 6.5 hours and this version takes about 4.5-5 hours depending on the model of thermocycler used. And the labor time goes down from one hour and 20 minutes to 50 minutes. The second difference is that the previous versions of the product recommended which enzymes to use, but didn't provide them. In this version, all of the reagents needed are incorporated in the kit."
There are about 70,000 people worldwide who have the disease with 30,000 in the U.S. There is no cure and the median predicted age of survival is 37.4 years, according to the Cystic Fibrosis Foundation (CFF; Bethesda, Maryland).
CF is inherited from parents who carry the mutated genes but are not sick with the disease. It causes mucus to build up and clog the lungs, making it difficult to breathe. That sticky overproduction of mucus can also cause bacteria to stick to airways, leading to infections and lung damage. But the problems with CF don't stop in the lungs. Mucus can also affect the digestive tract and pancreas, wreaking havoc on the body's ability to digest nutrients.
It is caused by mutations in the CF transmembrane conductance regulator (CFTR) gene. More than 1,500 such mutations have been identified to date.
Carrier screening is recommended for couples planning a pregnancy as it is possible for a person to carry a CF-causing gene mutation and have no symptoms of the disease. CFF reports that more than 10 million Americans are symptomless carriers of a CFTR gene mutation. Early diagnosis of CF in babies allows for earlier treatment intervention and can help improve a child's long-term health and quality of life.
With no cure in sight, the value of a test can be put to question. But Bridge-Cook said that prospective parents should be tested because, "If both parents have a CF mutation, there's a one in four chance that a baby would have CF. The utility of information in that context is that it enables people to make more informed choices from a reproductive standpoint.
"The other intended indication for the tests is as an aid in diagnosis of newborns," he said. "Babies who are diagnosed early do better and live longer than kids who are diagnosed later. One of the other aspects of CF is pancreatic insufficiency. That condition means babies or young children with CF start to have digestive problems. If its diagnosed early, dietary measures can be taken that lead to much better outcomes and longer survival."
The xTAG Cystic Fibrosis 39 Kit v2 screens for the 23 CFTR gene mutations and four variants (polymorphisms) recommended by the American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG), and 16 additional CFTR gene mutations from human blood specimens in a few hours.
The xTAG Cystic Fibrosis 39 Kit v2 offers physicians the ability to select the CFTR gene mutations for which they want to test. Doctors can choose to test a patient for the 23 ACMG/ACOG-recommended gene mutations or the entire panel of 39 CFTR gene mutations.
This newer version of the xTAG Cystic Fibrosis 39 Kit v2 will allow labs to avoid having different platforms for various testing purposes and save time and resources. And like the first generation xTAG CF test, the new xTAG Cystic Fibrosis 39 Kit v2 does not require reflex testing. All results are revealed and available for analysis at each run, if necessary.
Although Bridge-Cook would not discuss the cost of the test, he did say that CPT coding for reimbursement is well established and that the cost of the tests is less than the current reimbursement level, making it "fairly attractive."
Earlier this year Luminex launched the xTAG Cystic Fibrosis 39 Kit v2 and xTAG Cystic Fibrosis 71 Kit v2, as CE-marked in vitro diagnostics under the European Directive on In Vitro Diagnostic Medical Devices. According to the European Cystic Fibrosis Society, as many as one in 30 Europeans are carriers of a CF-causing gene mutation. The xTAG Cystic Fibrosis 71 Kit v2 can screen for all of the genetic mutations in the xTAG Cystic Fibrosis 39 Kit v2 plus an additional 32 mutations including those that are typically found in specific ethnic populations. Bridge-Cook said a version of the xTAG Cystic Fibrosis 71 Kit is on the way for FDA review and U.S. launch.
Elsewhere in the product pipeline:
• American Medical Systems (AMS; Minneapolis), a provider of medical solutions designed for restoring men's and women's pelvic health, said it has expanded its AMS 800 male artificial urinary sphincter product line with the addition of a 3.5 cm occlusive cuff to restore urinary continence to a wider range of male patients. The new smaller size cuff is designed specifically for patients suffering from stress urinary incontinence (SUI) who have a smaller urethra. According to the company, the 3.5 cm device provides physicians with another option beyond the more complex transcorporeal procedure for treating patients who have a urethra smaller than 4.0 cm, currently the smallest diameter cuff available. In addition to its smaller size, the 3.5 cm cuff features a specially designed contoured shell, curved adapter and reinforced fastener to maximize performance and effectiveness, AMS said. The company plans to evaluate the performance of the 3.5 cm cuff with a focused group of urologists starting this month and anticipates full-scale commercialization to take place in 1Q10.
• ATS Medical (Minneapolis) said that the FDA has approved a landmark clinical study in which cardiac surgeons will implant the ATS 3f Aortic Bioprosthesis in a younger aortic valve replacement patient population that has not been previously studied in a controlled and scientific manner. The Company believes that this study will ultimately demonstrate the excellent safety, efficacy and durability of the ATS 3f Aortic Bioprosthesis in this new patient population, while illustrating the performance necessary to maintain the active lifestyle of the younger population. The ATS 3f Aortic Bioprosthesis is an aortic valve designed to function just like a native valve. Its tubular design was inspired by how a native valve forms in utero: as a tube with sides that collapse when external pressure is applied. The primary benefit of the ATS 3f Aortic Bioprosthesis is its tubular design and that it restores physiologic non-turbulent blood flow and native-like stress distribution to the aortic root.
• Berlin Heart (The Woodlands, Texas) reported that it has completed enrollment in Cohort 1 of the Berlin Heart Excor Pediatric IDE Study after having received unconditional approval of the study from the FDA in November 2008. The Excor Pediatric ventricular assist device is a pulsatile, pneumatically driven cardiac support system for critically ill pediatric patients suffering from severe heart failure. It has been used in more than 600 pediatric patients worldwide ranging from newborns with 2.2 kg body weight to teenagers.
• Boston Scientific (Natick, Massachusetts) reported two-year data from its SYNTAX clinical trial comparing percutaneous coronary intervention (PCI) using the Taxus Express Paclitaxel-Eluting Coronary Stent System to coronary artery bypass graft (CABG) surgery. The overall results demonstrated no statistically significant difference between PCI and CABG in the composite safety endpoint (all-cause death, stroke and myocardial infarction [MI]).
• CardioNet (Conshohocken, Pennsylvania) reported clinical and reporting enhancements to the company's existing Mobile Cardiac Outpatient Telemetry service. These enhancements assist physicians to access more in-depth data to better diagnose atrial fibrillation, heart pauses, and ventricular tachycardia (a potentially dangerous fast heartbeat). CardioNet says the new clinical indicators are important for monitoring patients who are suffering from cardiac events, both symptomatic and asymptomatic. These indicators become even more important when used in combination with SomNet, CardioNet's program for identifying a sleep disorder indicator. In the case of SomNet, a more definitive diagnosis can be made as to the relationship of arrhythmias to sleep disorders. With this latest enhancement to the CardioNet MCOT service, doctors can see the frequency, time, and duration of cardiac events within every 24 hours.
• CryoLife (Atlanta) reported the first clinical implant of its BioFoam surgical matrix. BioFoam was used in a liver resection procedure following tumor removal as a supplemental measure to promote hemostasis (a complex process that stops bleeding) by sealing vessels. BioFoam, a protein hydrogel biomaterial, contains an expansion agent which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. It can be used intraoperatively to control internal organ hemorrhage, limit blood loss, and reduce the need for future reoperations in liver resections. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed. BioFoam received CE-mark approval for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.
• Fresenius Medical Care (Waltham, Massachusetts) has launched the KidneyTel system to provide an integrated care solution to assist patients, their families and their providers in managing the full range of health issues that kidney patients face on a daily basis. Fresenius claims the KidneyTel system will provide a key link in the creation of a "medical home" for the kidney patient, and will be an enabling technology for nephrologists and dialysis providers in establishing Accountable Care Organizations (ACO's) for the treatment of kidney patients. The KidneyTel system combines home telehealth monitoring device technology with an integrated care management program specifically tailored to the kidney patient. The system provides interactive daily contact and education with dialysis patients by monitoring health issues through a series of interactive questions on key health risk areas. It also collects daily vital signs of blood pressure, weight, and blood glucose. This information is transmitted each day to the KidneyTel IT system and call center.
• Medtronic (Minneapolis) reported the initiation and first enrollments of patients in COPE-HCV, the company's first-ever clinical study using an external pump infusion system to treat patients with the hepatitis C virus (HCV). The COPE-HCV study uses the Medtronic Paradigm Infusion System, a device currently approved by FDA for delivering insulin in patients with diabetes. It also incorporates the use of Medtronic's CareLink remote data management system to ensure patients enrolled in the study are compliant to study protocol for the trial period. The COPE-HCV study will deliver Intron A, via the Paradigm pump in combination with oral Rebetol. The comparison group in the study will use PegIntron and Rebetol.
• MultiGEN Diagnostics (San Diego) has launched a multi-target DNA sequencing technology (MultiGEN) for a wide range of clinical testing in molecular diagnostics. MultiGEN's technology allows detection and confirmation of multiple targets simultaneously using unmatched DNA sequencing, while still maintaining the highest possible sensitivity and specificity. These tests include panels for common pathogens causing an infectious syndrome (e.g. STDs - sexually transmitted diseases), acquired mutations in cancer that affect the response to drugs (e.g. K-ras, EGFR mutations for colorectal cancer therapy), and genetic predisposition to disease (e.g. Thrombophilia panel with Factor V, Prothrombin, MTHFR for clotting disorders).
• Precision Medical Devices (PMD; Fort Lauderdale, Florida) has recently added to its portfolio a novel approach of mechanically transferring motion through a hermetically sealed implanted control unit to a remote movable member. Part of the key to creating this technology was creating and developing a way of mechanically transferring motion through a hermetically sealed control unit that contains possibly corrosive materials or components. The company accomplished the mechanical transfer of motion via a system of coupling a small super-magnet to a larger one in a male/female coupling assembly, wherein the larger, donut-shaped magnet resides inside the control unit housing and slides on an inverted cylinder controlled by the unit's drive assembly. The smaller, male coupling fits in the orifice of the cylinder, which is external of the sealed compartment. The movable member, which in the case of the company's UI control device is a urethral valve assembly, is linked to the smaller magnet, and can be placed at locations away from the control unit.
• Qiagen (Venlo, the Netherlands) reported both the launch of a new Influenza A/H1N1 test. The new artus Influenza/H1 RG/LC RT-PCR Kit provides highly accurate results in approximately 40 minutes. Qiagen says this is unlike many current molecular solutions and most antigen-based H1N1 tests, which can either take up to several hours to produce results or, in the case of rapid protein-based tests, have been found to have a low sensitivity in detecting the virus. In addition, Qiagen's new kit can also detect infections with other known Influenza A and B strains likely to emerge and disseminate in the population during the upcoming flu season. The rapid turn around time of the company's new test can result in faster reporting of results which plays a key factor in monitoring and controlling outbreaks.
• Rochester Medical (Stewartville, Minnesota) reported the introduction of its Strata brands of Foley catheters. This new Foley product line features comfort layered technology. The company's StrataSI catheter is all-silicone, while the StrataNF version includes a nitrofurazone anti-infective matrix within the silicone. StrataSI catheters are available as standard all-silicone Foleys and as StrataNF a nitrofurazone-matrixed anti-infective all-silicone Foley catheter. The catheters are available in 5/10cc balloon sizes with diameters ranging from 14Fr to 26Fr. The product line also includes pre-connected catheterization trays with a StrataSI or StrataNF Foley catheter connected to a drain bag or urine meter (available in 14-18Fr).
• SynergEyes (Carlsbad, California) recently introduced a new advanced lens design for keratoconus patients. ClearKone is a contact lens designed to optimize and vault the predominant irregularities of the keratoconic cornea, thus effectively restoring vision to a vast majority of irregular cornea patients, without compromising comfort or eye health, even in the most challenging cases. SynergEyes claims its lenses are the only FDA-cleared hybrid contact lenses specifically designed for keratoconus vision correction. Incorporating HyperBond technology and HydrolEyes surface science, the SynergEyes contact lenses with FDA market clearance include: SynergEyes A for naturally occurring ametropia, targeting patients with astigmatism, current gas permeable lens wearers, and patients demanding optimized vision; the SynergEyes Multifocal lens for presbyopia; SynergEyes KC and ClearKone for keratoconus; and the SynergEyes PS for post-surgery and post-trauma refractive errors.
• Varian Medical (Palo Alto, California) said it is introducing the world's first low-energy radiotherapy system with image-guidance and RapidArc treatment capabilities for international cancer clinics. Varian claims the unique radiotherapy system is expected to make advanced care more affordable and more widely available to cancer patients around the world. "It's a comprehensive, cost-effective offering that will provide cancer patients with standard treatments as well as advanced techniques, including intensity modulated radiotherapy (IMRT), image-guided radiotherapy (IGRT), and RapidArc treatments," said Rolf Staehelin, Varian's European marketing director.
• Wright Medical Group (Arlington, Tennessee) reported the launch of the Ortholoc Polyaxial Locked Plating System for surgical treatment of foot and ankle fractures. The system consists of three instrument and plating trays, each designed to help the surgeon stabilize and fixate bone injuries of either the forefoot, calcaneus, or ankle region. The implants, plates and screws are made of titanium, and all incorporate Wright's Ortholoc polyaxial locking technology. "Polyaxial locking" allows the surgeon to tailor the angle of screw placement into the plate for best anatomic fit and then "lock" the screw to the plate.