Immunetics, Inc. announced it has been awarded a $500,000 Massachusetts Life Sciences Center Small Business Matching Grant (SBMG) to commercialize its BacTx® rapid test for detecting bacterial contamination in platelets.
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 1 in 2,000 platelet units that are contaminated.
"Rapidly detecting bacteria in platelet units presents a major challenge. Some current testing methods are ineffective because of low sensitivity. Others are overly difficult or time-consuming to perform close to transfusion," said Dr. Andrew Levin, president and scientific director, Immunetics. "According to the American Association of Blood Banks (AABB), a rapid test with high sensitivity performed close to the time of transfusion would represent a breakthrough in transfusion safety. The Massachusetts Life Sciences Center grant will help us transition the critical juncture from R&D to manufacturing scale-up and regulatory approval — and commercially launch BacTx," Levin said.
Immunetics has concluded clinical trials for BacTx® and plans to submit an application for approval to the U.S. Food and Drug Administration (FDA) this summer. With FDA approval, BacTx® could be launched as early as this year.
Immunetics was one of four life sciences firms named by the Massachusetts Life Sciences Center’s Board of Directors ("the Center") to share in $2 million in new SBMGs. The four recipients were chosen through a competitive process after extensive review by the Center’s peer review panel, Scientific Advisory Board, and Board of Directors. The grants foster job growth and technology commercialization in the Massachusetts Life Sciences Supercluster.
"Helping our life sciences companies grow is all about creating jobs," said Governor Deval Patrick. "As we continue to strengthen our global leadership in the life sciences, the Center’s Small Business Matching Grant Program is meeting an important need and making Massachusetts an even more attractive place for life sciences companies to locate and grow."
"The SBMG program is another example of the Center’s leveraging strategy," said Dr. Susan Windham-Bannister, President and CEO of the Massachusetts Life Sciences Center. "Federal SBIR/STTR grants provide Massachusetts companies with funds for their research and development; our SBMG program then provides the funds that companies need to bridge to commercialization. These four promising companies will bring cost-effective new treatments to the market and expand employment opportunities in Massachusetts. We are especially pleased that some of our grantees will contribute directly to the creation of biomanufacturing jobs in the Commonwealth."
"As an author of the legislation creating the Life Sciences Center several years ago, I am excited about the wonderful opportunity to grow the Life Sciences industry on the South Boston Waterfront," said State Senator Jack Hart (D-South Boston).
"Immunetics is doing important work to prevent infectious disease and improve public health in our state and around the world," said State Representative Nick Collins (D-South Boston), a member of the Joint Committee on Economic Development and Emerging Technologies. "This award by the Massachusetts Life Sciences Center is an example of the Commonwealth’s commitment to investing in our state’s economic future. It is also another sign of the continued emergence of the South Boston Waterfront as a center for innovation and job creation in the life sciences industry."
"I am extremely grateful for the continuing support by the Commonwealth and the Massachusetts Life Sciences Center of our mission to introduce innovations in the diagnosis of infectious diseases, as we grow our company in South Boston and become a stronger part of — and employer in — the very exciting Massachusetts Life Sciences community," Levin said.
Immunetics received two SBIR Phase II grants totaling approximately $4 million from the National Heart, Lung, and Blood Institute (NHLBI), an agency of the National Institutes of Health (NIH), 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.
With FDA approval, the BacTx® test will be marketed to blood centers and hospitals throughout the U.S. and around the world. In total, about 5 million platelet units are collected annually in the U.S. and an equal number outside the U.S.