News: Press Releases

MarlboroughMassachusetts: June 15, 2008:  PointCare Technologies, one of America’s leading companies providing diagnostic solutions in the worldwide effort to combat the spread of HIV/AIDS, received approval from the U.S. Food and Drug Administration (FDA) on January 14, 2008 for the PointCare NOW System. The PointCare NOW is the first FDA approved solution that was specifically designed for near-patient use in remote areas that combines a hematology profile, CD4 count and CD4% on one instrument and one report. 

The FDA regulates the intended use and ensures, through regulatory requirements, that approved medical devices manufactured in the United States perform to safety standards. For our customers this approval serves as a third party review of our scientific approach and may be useful as countries outside the United States look for impartial technical verification of a product.

 

The FDA approval further reinforces PointCare’s technical significance, specifically in the areas of equivalence to traditional hematology and CD4 testing technology utilized in many countries. Approval from the FDA opens up opportunities for the PointCare technology to be utilized in clinical settings in the Unites States.

 

The PointCare NOW is currently available on the African continent and the Caribbean Rim, and initiatives are underway to expand availability to India, Indonesia and Papua New Guinea.

 

Created in response to the needs of healthcare workers in under-served rural and urban areas, the PointCare NOW is a self-contained unit that goes anywhere, and runs on alternative methods of power. It provides practitioners with the diagnostic tools they need to deliver appropriate treatment and monitoring to HIV patients.

 

The Company was started by a group of experienced entrepreneurs and medical device experts. Dr. Petra Krauledat, co-founder, CEO of PointCare, is an expert in viral diagnostics and has a long career of creating successful startups and managing the development and manufacture of breakthrough products for international diagnostics companies.

 

Dr. W. Peter Hansen, co-founder and Chief Science Officer of PointCare, is a prolific commercial inventor in the field of biomedical analysis. His inventions are widely incorporated in significant products for flow cytometry, immunoassay and nucleic acid detection.

 

Founded in 2002, PointCare has always been vigilant in providing quality products and services to customers. Dr. Krauledat notes: “We are very pleased to receive FDA approval for the PointCare NOW System. Our first working portable system, the AuRICA, received FDA approval in November 2004 and the PointCare NOW allows us to provide additional diagnostic information to practitioners.”

 

As a regulated company in the United States, PointCare is required to maintain a Quality Management System (QMS). Both the company’s ISO-certified QMS and its manufacturing facility are subject to routine inspection by the FDA and annual inspection by the ISO registrar.

 

PointCare’s focus and diligence to provide essential diagnostic solutions to resource-limited urban and rural regions has resulted in designing a point-of-care solution that has received a Moderate Complexity CLIA (Clinical Laboratory Improvement Amendments) rating from the FDA for all parameters provided including CD4 count and CD4%. The main objectives of the CLIA Regulation are to ensure the accuracy, reliability and timeliness of test results regardless of where the test is performed.

 

Dr. Krauledat adds: “The PointCare NOW is a safe and effective system that brings diagnostics to the people and we’ve learned that simple to use diagnostics can make the difference!”

PointCare Technologies is one of America’s leading companies in the worldwide effort to combat the spread of HIV/AIDS. This privately held, FDA-registered, ISO-certified medical diagnostics company invents, develops, manufactures and markets medical diagnostic products. PointCare brings diagnostic capabilities to resource-limited urban and rural regions, enabling immediate identification and treatment of infectious diseases by healthcare professionals. 

 The company’s mission is to provide better diagnostic care to disadvantaged populations worldwide. PointCare collaborates with clinicians, scientists, engineers and other thought-leaders around the globe, and its strategic partners include some of the world’s most advanced clinical and diagnostics companies. For more information, you are warmly invited to visit www.pointcare.net

 

Media Contacts:

Kim Beer, Director of Marketing
Tel: 508-281-6926 x 26

Bobby Feigler, Vice President Worldwide Sales & Marketing
Tel: 508-281-6926 x 10

PointCare Technologies
181 Cedar Hill Street
Marlborough, MA 01752