First Light Diagnostics Welcomes New Vice President of Quality Assurance and Regulatory Affairs
April 10, 2019
CHELMSFORD, Mass. (April 10, 2019) – First Light Diagnostics, a developer of breakthrough automated products for the rapid, sensitive and cost-effective diagnosis of life-threatening, antibiotic-resistant infections, today announced the hiring of Andrew Connerty as its vice president of quality assurance and regulatory affairs.
Andrew Connerty brings more than 25 years of quality systems management expertise at a strategic and tactical level. He has successfully formed effective quality departments and deployed compliant quality systems for a broad range of medical devices, in-vitro diagnostics, biologic, bioabsorbable devices and life science products.
“Andrew brings an impressive pedigree to the First Light senior leadership team,” said David Macdonald, president and CEO of First Light Diagnostics. “His experience driving compliance with quality management systems and with regulatory submissions will be indispensable as we navigate the regulatory process for our commercialization efforts.”
Andrew’s experience includes organizations such as Johnson & Johnson, Confluent Surgical, SeraCare Lifesciences, RainDance Technologies and Bio-Rad Laboratories. Andrew earned his mechanical engineering degree from Wentworth Institute of Technology.
“I am thrilled to be joining First Light Diagnostics at such an exciting time in the company’s development,” said Andrew Connerty. “First Light’s innovative, rapid technology to get patients on the right antibiotic at the onset of infection is a game changer.”
First Light’s MultiPath technology provides pathogen identification in 30 minutes and AST results in four hours directly from the patient sample, thereby enabling treatment decisions one or two days quicker than with traditional AST methods. This shorter time period is significant because it allows for the correct treatment to be administered during the onset of infection.
In preparation for an FDA submission, First Light Diagnostics has begun to install systems at customer clinical study sites. FDA clearance is expected around the end of 2019.
About First Light Diagnostics
First Light Diagnostics is developing and preparing to commercialize innovative diagnostic products for the rapid, sensitive and cost-saving detection of life-threatening infections, and for combating the spread of antibiotic resistance. Don Straus is the company’s founder and primary inventor of the company’s core scientific technology. Based on its proprietary MultiPath detection technology, First Light’s products combine the clinical performance of the most advanced commercial laboratory tests with speed, cost-effectiveness and ease of use. The tests rapidly detect infections, identify infectious agents and determine effective targeted antibiotic therapy. This will improve patient outcomes, reduce health care costs and prevent the inappropriate use of powerful antibiotics. To learn more, please visit www.firstlightdx.com.
Read the full press release here.