Luminex Corporation Receives Health Canada Approval for its Comprehensive Genotyping Assay, xTAG® CYP2D6 Kit v3
Jan 28 15
Luminex Corporation announced it has received a Health Canada Class 3 Device License approval for its comprehensive genotyping assay, xTAG® CYP2D6 Kit v3. Identification of patient CYP2D6 genotypes can help clinicians individualize drug treatment by selecting appropriate therapies. Cytochrome P450 2D6 (CYP2D6) is a clinically important gene that encodes a drug-metabolizing enzyme. CYP2D6 metabolizes greater than 25% of the drugs in use present including some cardiovascular and anti-cancer drugs, anti-psychotics, anti-depressants, pain-medications, beta blockers, and antiarrhythmics. Variations in the CYP2D6 gene can result in distinct drug metabolizing profiles leading to potentially sub-optimal drug responses, such as drug toxicity, adverse drug reactions (ADRs), or inadequate therapeutic effect. Approximately 1.6% of patients admitted to acute care hospitals in Canada experience a serious adverse drug reaction. With almost 2.5 million annual hospital admissions in Canada of the type studied, statistics suggest that an estimated 40,000 serious adverse drug reactions occur annually in Canadian acute care hospitals. xTAG CYP2D6 Kit v3 is an in vitro diagnostic assay that analyzes a patient's CYP2D6 genotype from DNA extracted from a blood sample and is used to aid physicians in determining therapeutic strategy for drugs metabolized by the cytochrome P450 2D6 gene product. The assay is run on the flexible Luminex® 100/200 instrument. This new version of the kit optimizes performance on the 17 allele and features an updated software algorithm that detects all 17 genotypes that the assay is cleared for, including deletion and duplication genotypes. Additionally, another pharmacogenetic assay by Luminex, xTAG CYP2C19 Kit v3, received Health Canada approval in 2014. The CYP2C19 enzyme is responsible for metabolizing a variety of drugs used to treat ulcers, seizures, malaria, anxiety, and some antidepressants.
Luminex Corporation Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-15-2015 08:30 AM
Dec 29 14
Luminex Corporation Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-15-2015 08:30 AM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Nachum Shamir, Chief Executive Officer and President.
David S. Reiter Intends to Resign as Senior Vice President, General Counsel and Corporate Secretary from Luminex Corporation
Dec 22 14
On December 19, 2014, David S. Reiter announced Luminex Corporation of his intention to resign as the company's Senior Vice President, General Counsel and Corporate Secretary to pursue other interests. The company anticipates Mr. Reiter's resignation will be effective on or about April 1, 2015. Mr. Reiter's departure is amicable and is not due to any disagreement with the company, the company's new President and Chief Executive Officer or any matters relating to the company's operations, policies or practices. Mr. Reiter will be rejoining his independent legal practice. The company and Mr. Reiter have entered into a consulting agreement to be effective upon his resignation date pursuant to which Mr. Reiter will advise the company's Chief Executive Officer and General Counsel on legal matters and other transitional and consulting services to be reasonably requested and authorized by the company's Chief Executive Officer or General Counsel from time to time. The term of the consulting agreement will be until the end of 2015.
Luminex Corporation Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014; Revises Revenue Guidance for the Full Year of 2014; Provides Capital Expenditures Guidance for the Year 2015
Oct 27 14
Luminex Corporation reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported revenue of $56,684,000 compared to $50,780,000 a year ago. Income from operations was $4,996,000 compared to loss from operations of $4,194,000 a year ago. Income before income taxes was $4,981,000 compared to $2,428,000 a year ago. Net income was $5,550,000 or $0.13 per basic and diluted share compared to $796,000 or $0.02 per basic and diluted share a year ago. Net cash provided by operating activities was $11,527,000 against $11,134,000 a year ago. Purchase of property and equipment was $5,540,000 against $6,914,000 a year ago. Adjusted income from operations was $11,884,000 compared to $3,380,000 a year ago. Adjusted net income was $11,497,000 or $0.27 per diluted share compared to $2,335,000 or $0.06 per basic and diluted share a year ago. Performance during the third quarter was bolstered by the strength of direct sales force, achieving the strongest quarter in assay sales, since going direct at the beginning of the 2013.
For the nine months, the company reported revenue of $168,877,000 compared to $158,267,000 a year ago. Income from operations was $17,952,000 compared to loss from operations of $705,000 a year ago. Income before income taxes was $17,911,000 compared to $5,958,000 a year ago. Net income was $16,241,000 or $0.39 per basic and diluted share compared to $1,980,000 or $0.05 per basic and diluted share a year ago. Net cash provided by operating activities was $33,191,000 against $17,492,000 a year ago. Purchase of property and equipment was $11,795,000 against $15,136,000 a year ago. Adjusted income from operations was $34,220,000 compared to $21,837,000 a year ago. Adjusted net income was $29,866,000 or $0.71 per diluted share compared to $17,324,000 or $0.41 per diluted share a year ago.
The company has revised its 2014 annual revenue guidance to a range of between $225 and $228 million from $225 and $240 million. The company currently expects consolidated R&D expenditures for the full year of 2014 to be in the 20% of revenue range based on current revenue guidance. SG&A costs were also relatively flat, but given the increase in revenue it represented 38% of revenue compared to 42% in the prior year period.
The company expects to increase in aggregate capital expenditures in 2015 related to manufacturing automation initiatives for the ARIES cassettes.