Nova Biomedical Obtains CE Mark Certification for Allegro™ Analyzer
New capillary blood analyzer for point-of-care testing in primary care settings

Contact: Douglas Curley
(781) 647-3700 ext. 109

Nova Biomedical Obtains CE Mark Certification for Allegro™ Analyzer
New capillary blood analyzer for point-of-care testing in primary care settings

Waltham, MA –Nova Biomedical is pleased to announce CE mark certification for Allegro, a capillary blood analyzer for point-of-care testing in primary care settings. Allegro and its StatStrip A companion meter provide 14 clinically important tests to monitor glycemic control, assess cardiac risk with a full lipids panel, and assess kidney function. All results are ready during the patient visit, simplifying clinic workflow and producing cost savings for providers, while offering clinical benefits for patients.

All Allegro tests use easy capillary fingerstick sampling and disposable test cartridges or strips. To monitor glycemic control, Allegro provides HbA1c, glucose, and estimated average glucose tests. To assess cardiac risk, Allegro provides total, HDL, non-HDL, and LDL cholesterol tests, cholesterol/HDL ratio, and triglycerides tests. To assess kidney function, Allegro provides urine creatinine, urine albumin, and urine a1bumin/creatinine ratio, and blood creatinine with eGFR tests.

Allegro is the only analyzer that can measure HbAlc, lipids, glucose, and creatinine from a capillary sample. Its innovative design comprises dual measurement bays, which offers the unique ability to measure two cartridges simultaneously, doubling throughput and improving efficiency.

Allegro's companion meter wirelessly transmits results to the analyzer, where they combine with all cartridge test results for one patient report. All results can be transmitted to electronic medical records for providers to review with patients during the visit. Having immediate results during the patient visit reduces clinic follow-up calls, letters, and patient re-visits, and improves patient satisfaction, compliance with care plans, and outcomes.

"We at Nova Biomedical are extremely excited to obtain CE mark certification to launch Allegro in CE regulated countries, and we continue our clinical studies with an eye toward FDA clearance in the coming months. Allegro provides a solution to a clear and fast-growing market need for point-of-care testing to support the management of diabetes and related comorbidities, such as kidney and cardiovascular diseases, in primary care settings," said Douglas Curley, Allegro Product Manager at Nova. "As chronic disease management continues to shift to primary care settings, clinicians need fast, accurate results during the patient visit for earl y detection and ongoing monitoring, and to make therapy changes. We are confident that Allegro will meet this need."

Allegro's HbA1c accuracy is certified by the National Glycohemoglobin Standardization program (NGSP), and total cholesterol and HDL cholesterol are certified by the U .S. Centers for Disease Control Cholesterol Reference Method Laboratory Network.

Allegro is available now for purchase in CE regulated countries.

About Nova Biomedical
Incorporated in 1976 and based in Waltham, MA, Nova Biomedical is a world leader in the development and manufacturing of state-of-the-art, whole blood, point-of-care and critical care analyzers, as well as providing the biotechnology industry with the most advanced instruments for cell culture monitoring. Nova is one of the fastest growing in vitro diagnostic companies in the world. Nova’s biosensor technology is incorporated in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for rapid measurement of over 20 analytes. Nova’s biotechnology-specific BioProfile line has pioneered comprehensive cell culture testing, providing over 20 critical cell culture tests with over 12 unique instrument offerings for broad range of cell culture applications. Nova employs over 1,100 people worldwide and has wholly owned subsidiaries located in Brazil, Canada, France, Germany, Great Britain, Italy, Japan, and Taiwan. Certified by the International Organization for Standardization, Nova has manufacturing operations located in the U.S., Taiwan, and Brazil.