|Luminex Receives FDA and European Clearance xTAG CYP2C19 Kit; Alexion Presentation Shows Phase 2 Study of Asfotase Alfa|
|By Mary Davila|
|Monday, 23 September 2013 23:22|
Luminex Corporation (NASDAQ: LMNX) announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit. This new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.
"Since cytochrome [CYP450] enzymes are responsible for metabolizing over half of all drugs on the market today, it is important for a physician to have valuable information to determine whether a patient's specific genotype may impact their drug response," said Patrick J. Balthrop, president and chief executive officer of Luminex. "Our growing portfolio of pharmacogenetic assays include both FDA cleared and CE marked xTAG CYP2D6 and CYP2C19 assays demonstrating our commitment to offer testing laboratories regulatory cleared assays that are safe and effective for use as an aid in patient management decisions."
Cytochrome P450 2C19 (CYP2C19) is a clinically important gene that encodes a phase one drug metabolizing enzyme. The CYP2C19 enzyme is responsible for metabolizing a variety of prodrugs and drugs used to treat a number of conditions such as ulcers, seizures, malaria and anxiety. It is also important in metabolizing drugs such as beta-blockers, anti-clotting agents and some antidepressants.
Genetic variations in the CYP2C19 gene can result in distinct drug metabolizing phenotypes leading to sub-optimal drug responses, such as drug toxicity, adverse drug reactions (ADRs), or inadequate therapeutic effect. The FDA Adverse Events Reporting system (FAERS) estimated nearly 800,000 ADRs in the U.S. and Europe combined for the year 2011.1 The incidence of serious and fatal ADRs has been rising with the increase in the number of medications prescribed. An estimated $3.5 billion is spent on additional medical cost associated with ADRs annually and at least 40% of ambulatory ADRs may be preventable.2
Luminex's xTAG CYP2C19 Kit is an IVD assay that analyzes a patient's CYP2C19 genotype from genomic DNA extracted from EDTA or citrate anticoagulated whole blood samples to aid clinicians in determining therapeutic strategy for therapeutics metabolized by the cytochrome P450 2C19 gene product. The assay is run on the versatile Luminex® 100/200™ or MAGPIX® instruments.
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) announced that researchers have presented data from an ongoing multinational Phase 2 study of asfotase alfa in infants and young children with hypophosphatasia (HPP), an inherited, ultra-rare metabolic disorder that in this patient population leads to progressive damage to multiple vital organs, destruction and deformity of bones, and death. The study met its primary endpoint: infants and young children with HPP treated with asfotase alfa had significant improvement in skeletal mineralization from baseline as assessed radiographically after 24 weeks of treatment (p=0.001). This response was observed as early as 12 weeks and improvement continued at 48 weeks. Ninety three percent of the patients survived the first 48 weeks of treatment with 80% of patients.
Astro-Med, Inc. (NASDAQ: ALOT) is announcing the worldwide release of its newest inkjet color label printer, the Kiaro! 200, which will be marketed by its QuickLabel Systems business unit.
ChemoCentryx, Inc. (Nasdaq:CCXI), today announced that Thomas J. Schall, Ph.D., President and Chief Executive Officer, will present at BioCentury's NewsMakers in the Biotech Industry Conference on Friday, September 27, 2013, at 9:00 a.m. Eastern Time at the Millennium Broadway Hotel and Conference Center in New York, NY.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX) announced today the closing of its initial public offering of 4,800,000 shares, resulting in aggregate gross proceeds of $62.4 million, before underwriting discounts, commissions and expenses.
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced the closing of the exercise in full of the underwriters' option to purchase an additional 2,625,000 shares of common stock of Galena.
KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today announced that the company will present at the BioCentury NewsMakers in the Biotech Industry Conference on September 27 at the Millennium Broadway Hotel & Conference Center in New York City.
Luminex Corporation (NASDAQ: LMNX) today announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit.
MEDIFIRST SOLUTIONS, INC. (OTCQB: MFST) is pleased to announce that it is an exhibitor at the IECSC Broward County Florida Conference. IECSC Florida is a valuable educational resource that provides attendees with the perfect venue to learn about new trends, find new product lines, discover new tools, techniques and treatments that will help their careers and businesses grow.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) today announced the closing of its previously announced underwritten public offering of 6,100,000 shares of its common stock, as well as 915,000 additional shares of its common stock pursuant to the full exercise of the over-allotment option granted to the underwriters.