MassDevelopment Loans Allow Immunetics to Manufacture & Launch BacTx Test for Bacterial Contamination in Blood Platelet Transfusions
July 21, 2011
MassDevelopment has provided loans of $505,000 to Immunetics, Inc., of Boston to help to finance the manufacture and launch of its BacTxÂ® rapid test for detecting bacterial contamination in platelets.
Immunetics has concluded clinical trials for the BacTxÂ® test and expects to submit an application for approval to the U.S. Food and Drug Administration (FDA) later this summer. With FDA approval, BacTx could be launched later this year and marketed to blood centers and hospitals domestically and internationally.
MassDevelopment's financing consists of two loans — $255,000 under the Manufacturing Growth Initiative and $250,000 through the Southeast Regional Loan Fund — that will finance new equipment and capital improvements needed for the commercialization of the BacTx diagnostic test. A 70 percent guarantee from MassDevelopment's Export Development Fund will support the loans.
â€œThe cutting-edge technology at Immunetics combining life sciences and manufacturing showcases two of the main drivers of the Massachusetts economy,â€ said MassDevelopment President and CEO Marty Jones. â€œThe equipment and facility improvements will help the company expand its production capabilities for vital new blood screening tests in its pipelineâ€
â€œThe financing from MassDevelopment provides a critical link in our ability to bring this important diagnostic product to market — as we grow and expand our manufacturing operations in the Boston Marine Industrial Park,â€ said Dr. Andrew Levin, chief executive officer of Immunetics.
The approval of the MassDevelopment loans follows an announcement in May of a $500,000 Small Business Matching Grant (SBMG) from the Massachusetts Life Sciences Center also supporting the commercialization of the BacTxÂ® rapid test.
Platelets are a vital blood product enabling clotting, and patients suffering from trauma, surgical procedures, cancer, or chemotherapy must receive platelet transfusions to survive. Bacterial contamination of platelets is the leading cause of infection during transfusion, with patients facing the risk of severe or fatal transfusion-associated sepsis from the roughly one in two thousand platelet units that are contaminated.
The rapid detection of bacteria in platelet units presents a major challenge for blood centers and hospitals as some current testing methods are ineffective because of low sensitivity, while others are difficult or time-consuming to perform close to transfusion.
A rapid test with high sensitivity performed close to the time of transfusion would represent a breakthrough in transfusion safety, according to the American Association of Blood Banks.
If approved by the FDA, the BacTx test could meet that need, Levin said.
About five million platelet units are collected annually in the United States along with an equal number in other countries.
Immunetics previously received two Small Business Innovation Research Phase II grants totaling approximately $4 million from the National Heart, Lung, and Blood Institute, an arm of the National Institutes of Health, which supported the research and development of the test. The technology underlying the test is protected by a recently issued U.S. patent, and foreign patents with approved claims are in process of issue.
MassDevelopment, the state's finance and development agency, works with businesses, nonprofits, financial institutions, and communities to stimulate economic growth across the Commonwealth. During FY2010, MassDevelopment financed or managed 238 projects in 104 communities across the state generating investment of nearly $1.4 billion in the Massachusetts economy.
Immunetics Inc. (www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and pathogen detection, and for more than ten years has been a leading innovator of tests for bacterial, viral, and parasitic diseases. The company produces and markets a range of infectious disease assay kits and instruments. Its mission is to deliver better, cost-efficient care through more accurate diagnosis. Immunetics is headquartered in Boston. Follow Immunetics on Twitter at twitter.com/immunetics.