erba diagnostics inc (ERB) Key Developments
ERBA Diagnostics, Inc. Attains CE Mark for HB Vario A1c Detection System and Reagents for Management of Diabetes
Jan 21 15
ERBA Diagnostics, Inc. has attained CE Mark clearance for the HB Vario A1c detection system and associated reagents. Monitoring A1c values can help healthcare providers manage complications from diabetes in patients. The CE Mark registration provides marketing authorization in the 28 member states of the European Union and can be used for registration in additional countries who recognize the CE Mark. Following CE Mark clearance in December 2014, ERBA Diagnostics has commenced a limited launch of the HB Vario A1c detection system and associated reagents in Europe through its direct sales team and a limited launch in India through its distributor, and indirect parent company, Transasia Bio-Medicals. The Hb-Vario is capable of processing up to 10 samples at a time with an assay time of just around 4 minutes per sample. The Hb-Vario can sample from a wide number of sample tubes. The touchscreen of the Hb-Vario, the interactive software and user-friendly features makes the unit extremely easy to use. Diabetes continues to be one of the major challenges worldwide to the healthcare industry, a challenge that is pronounced in developing countries and emerging markets. It is currently estimated by the World Health Organization that 347 million people worldwide are afflicted with diabetes.
ERBA Diagnostics, Inc. Presents at 8th Annual OneMedForum 2015, Jan-12-2015 02:40 PM
Dec 19 14
ERBA Diagnostics, Inc. Presents at 8th Annual OneMedForum 2015, Jan-12-2015 02:40 PM. Venue: San Francisco Marriott Marquis, Parc 55 Wyndham, Union Square, San Francisco, California, United States. Speakers: Mohan Gopalkrishnan, Chief Executive Officer.
ERBA Diagnostics, Inc. Presents at LD Micro Conference, Dec-04-2014 07:30 AM
Nov 26 14
ERBA Diagnostics, Inc. Presents at LD Micro Conference, Dec-04-2014 07:30 AM. Venue: Luxe Sunset Boulevard Hotel, 11461 Sunset Boulevard, Los Angeles, California, United States. Speakers: Mohan Gopalkrishnan, Chief Executive Officer.
ERBA Diagnostics, Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014; Provides Revenue Guidance for 2015
Nov 10 14
ERBA Diagnostics, Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. The company recorded quarterly revenue of $6,469,488 and net income of $127,918 for the third quarter of 2014. This compares to revenue of $6,940,713 and net income of $129,229 for the third quarter of 2013. This decrease in revenue is primarily attributed to the affects from sales to Russia and Africa, deferred production related to consolidation of manufacturing and the phasing out of older lower margin products as ERBA Diagnostics shifts toward selling higher margin instruments and consumables. Income from operations was $351,066 for the third quarter of 2014, compared to $78,541 in the third quarter of 2013. Income before provision for income taxes was $157,051 against $156,523 a year ago.
For the nine months, the company reported net revenue of $20,381,257 against $20,538,079 a year ago. Income from operations was $1,154,282 as compared to $229,924 a year ago. Income before provision for income taxes was $832,120 against $49,498 a year ago. Net income was $743,944 or $0.01 per diluted share against net loss of $30,490 a year ago.
Looking ahead to 2015 and beyond, the company expected further revenue growth to come from a combination of new products are developing or may distribute.
ERBA to Feature New Urinalysis and Diabetes Monitoring Systems
Nov 7 14
ERBA Diagnostics, Inc. will be featuring two new fully automated diagnostic testing instruments, the Hb-Vario diabetes monitoring system and the Laura XL urinalysis processer, at MEDICA 2014 in Dusseldorf Germany, November 12-15. ERBA Diagnostics will also showcase its comprehensive range of testing products, including the Elisa systems for autoimmune and infectious disease, chemistry analyzers, hematology analyzers, urine analyzers and coagulation systems. The Hb-Vario is an automated HPLC system that is capable of measuring both Glycated hemoglobin (HbA1c) and HbA2 for the monitoring of diabetes. ERBA Diagnostics anticipates launching the product initially in Europe, following CE Mark clearance, followed by a release in select emerging markets. Diabetes continues to be one of the major challenges worldwide to the healthcare industry. The benefits of monitoring HbA1c values to better manage diabetes is well documented in numerous studies and is a key to reducing co-morbidity complications. HbA1c testing is poised to emerge as a popular technology with outpatient clinics and small hospital-based laboratories according to a industry analyst report, which forecasts that the global market for diabetes diagnostics is estimated to reach $26 billion per year by 2015. The Laura XL is a fully automated urinalysis and sedimentation processor with the capability to automate urine strip reading as well as performing sedimentation cell analysis for abnormal samples. ERBA Diagnostics will be the exclusive distributor for the product in the U.S. and Latin America following receipt of regulatory approvals and clearances. Industry analysts have estimated that the worldwide in vitro diagnostics urinalysis market is approximately $600 million per year.