Real-Time Assay for Respiratory Viruses
Prodesse, Inc. (Milwaukee, Wis.) has received FDA approval of its ProFlu+ Assay test, which simultaneously detects the common respiratory viruses-influenza A, influenza B, respiratory syncytial virus (RSV) A-in a patient's respiratory secretions. The test provides results in as few as 3 hours.
The test uses a multiplex platform that allows several tests to be processed using the same sample, and uses real-time polymerase chain reaction technology.
The test's rapidity allows medical practitioners to quickly determine whether a respiratory illness is caused by one of these viruses and initiate the appropriate treatment at the most effective times.
In clinical tests, ProFlu+ Assay's overall clinical sensitivity and specificity were 98% and 83%, respectively.
New Test Assesses Breast Cancer Risk
The FDA has approved the topoisomerase 2 alpha (TOP2A) fluorescent in situ hybridization (FISH) pharmDx test to help assess the risk of tumor recurrence and long-term survival for patients with relatively high-risk breast cancer. The test is the first to be approved to test for the TOP2A gene in cancer patients. It uses FISH to detect and confirm gene or chromosome abnormalities.
When used with other clinical information and laboratory tests, the TOP2A FISH test can provide additional insight on the likely clinical course for breast cancer patients as well as valuable information to assist healthcare providers and patients in better understanding the biology of breast cancer disease.
The test is suitable for breast cancer patients who are premenopausal or for whom tumor characteristics suggest a higher likelihood of tumor recurrence or decreased survival.
Drug-Eluting Stent for Narrowed Arteries
The FDA approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries or the blood vessels supplying the heart.
The Endeavor is the first drug-eluting stent approved since 2004 and the first since FDA convened its Circulatory System Devices Panel in 2006 to discuss evidence of the rare risk of blood clots occurring in patients who receive drug-eluting stents.
Manufactured by Medtronic, Inc., (Minneapolis, Minn.), the device is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. It is crimped around a balloon and delivered to the narrowed section of the coronary artery via a long, thin catheter during an angioplasty. Once the stent is positioned, the balloon is inflated, expanding the stent into the vessel wall where it will remain in place after the balloon is deflated and removed. The stent acts as a mechanical scaffold to keep the artery open.
Slow release of zotarolimus over time prevents the artery from re-narrowing when new tissue begins to form. This process, known as restenosis, can eventually require a repeat angioplasty.
Medtronic provided data from seven clinical trials in its marketing application. Studies showed that the Endeavor significantly reduced the number of major coronary events-myocardial infarction, cardiac death, and repeat procedures to reopen the artery-compared to a bare-metal stent (a stent without a drug coating). It also cut the restenosis rate by about half.
Test Detects Warfarin Sensitivity
AutoGenomics, Inc. (Carlsbad, Calif.) has received FDA approval to market its Infiniti 2C9-VKORC1 Multiplex Assay for the determination of individual response to treatment with warfarin. The new test determines variants of CYP 2C9, an enzyme that has a role in the metabolism of warfarin that can influence dosing. It can detect 15 genetic variants to characterize a wide spectrum of ethnicities.
In August 2007, the FDA changed the labeling for warfarin to include information explaining that people with variations of the CYP 2C9 and VKORC1 genes may respond differently to the drug. The test's rapid results allow for same-day dosing. The results of the test can help optimize efficacy and minimize adverse effects of warfarin treatment.
System Approved for Asthma Management
Apieron, Inc. (Menlo Park, Calif.) announced the FDA's approval of its Insight eNO System to measure airway inflammation, which is a way to assist in the management of patients with asthma.
The Insight eNO System measures exhaled nitric oxide (eNO), an established indicator of airway inflammation and asthma control. The system is a highly accurate device, expressly designed for the healthcare provider's office. It is noninvasive, safe, easy to use, and provides results in less than 1 minute. Apieron's unique biosensor detects trace amounts of nitric oxide molecules in a single human breath.
The Insight eNO includes a small desktop monitor with an easy-to-read display, trend analysis capabilities, and a user-friendly interface. Disposable, single-use sensors measure nitric oxide accurately in less than 1 minute. Disposable single-use breath tubes make the process hygienic and convenient for the user to exhale into the device. Patient data can be stored and maintained for trend analysis or downloaded to a printer for insurers' and patients' files.
New Indication for Regenerator Announced
Rhytec, Inc. (Waltham, Mass.) has received FDA approval to market its Portrait Plasma skin regeneration thermal device for the treatment of acne scars. The product is already approved for treatment of facial and nonfacial areas for wrinkles, superficial skin lesions, actinic keratosis, seborrheic keratosis, and viral papillomata.
Portrait Plasma is a noninvasive, inpatient technology clinically proven to treat unhealthy signs of aging often accelerated by sun exposure and acne scars. According to the manufacturer, Portrait Plasma treats 100% of the skin, stimulating a natural response that produces healthier regeneration of the skin. It differs from lasers, which target only specific components of the skin. Furthermore, Portrait Plasma offers less downtime and little to no risk of hypopigmentation, scarring, or discoloration.
Test Detects, Identifies Cystic Fibrosis Mutations
The FDA approved Third Wave Technologies, Inc.'s (Madison, Wis.) InPlex CF for the identification and detection of cystic fibrosis mutations in patient DNA samples.
The test uses a microfluidic card and analyte-specific reagents to simultaneously detect and identify genetic mutations that provide information about the cystic fibrosis carrier status of adults who are of reproductive age. The test may also be used as an aid in newborn screening for cystic fibrosis and for confirmatory diagnostic testing of the disease in newborns and children, according to the company.
The test achieved 100% agreement on cystic fibrosis-positive samples and 99.96% overall agreement when compared with DNA sequencing, the standard for genotype determination.
FDA Clears MRSA Screening Device
The FDA approved Thermo Fisher Scientific, Inc.'s (Waltham, Mass.) Spectra MRSA, a test designed to screen for methicillin-resistant Staphylocccus aureus (MRSA). The test has the highest positive predictive value commercially available for MRSA screening, and provides accurate results within 24 hours. The test is manufactured, distributed, and sold under the Thermo Fisher specialty brand, Remel.
The test is a ready-to-use, cost effective, labor saving device that can be adopted in any healthcare facility to enable continuous testing of patients. The test medium is easy to read, with MRSA appearing as distinctive dark blue colonies.