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Posts Tagged ‘bacterial’


Wednesday, June 13th, 2012

Immunetics Receives FDA Clearance for BacTx Rapid Test for Bacterial Contamination of Platelets

BOSTON, MA – June 12, 2012 – Immunetics, Inc., has received U.S. Food and Drug Administration (FDA) clearance for its BacTx® rapid test for bacterial contamination in platelet units, Andrew E. Levin, Ph.D., Immunetics Chief Executive Officer and Scientific Director, announced today.

Immunetics’ BacTx rapid test addresses the greatest infectious risk in transfusion today. An estimated 1 in 2,000 platelet units is contaminated with bacteria — and medical studies are increasingly showing that such contamination is a significant cause of illness and death among transfusion recipients.

The FDA clearance allows use of the BacTx test on leukocyte-reduced whole blood-derived platelet units, a type of platelet preparation which exhibits relatively high rates of bacterial contamination due to the pooling of units from multiple donors. In the studies reported to the FDA, the BacTx test detected all of the bacterial strains tested, with sensitivity and specificity meeting or exceeding clinical requirements.

“Existing approaches to the detection of bacterial contamination have fallen short, leaving patients at risk. They rely mainly on the culturing of the platelet units, a decades-old method that takes up to several days to yield a result,” Dr. Levin noted.

“By contrast, the BacTx test can be run in about 45 minutes, making it suitable to test platelet units shortly before they are transfused into a patient,” he said.

With the FDA clearance, the BacTx test is now available for immediate evaluation and sale. Additional trials are underway to expand the range of applications for the test.

“Receiving FDA clearance for the BacTx test is a critical milestone for Immunetics,” Levin said, “culminating years of work in which we’ve taken a novel technology from concept through clinical trials and regulatory approval — and are now ready to address an urgent need in the blood bank and transfusion services market.”

Worldwide, more than 10 million platelet units are collected per year.

The results of clinical trials of the BacTx test were presented by Drs. Andrew Heaton (NSLIJ Health System, New York) and Michael Jacobs (University Hospital – Case Medical Center, Cleveland), the clinical investigators leading the trials, at the American Association of Blood Banks (AABB) meeting in October 2011.

Immunetics has issued patents on the BacTx technology, which was initially developed with support from the National Institutes of Health. The company has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for Babesiosis and Chagas disease — both of which are emerging risks to the blood supply.

For more information about the BacTx® rapid test for bacterial contamination in platelet units, visit the Immunetics website at http://immunetics.com/bactx.html or contact the company at 1-617-896-9100 or toll-free at 1-800-227-4765.

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About Immunetics
Immunetics Inc. (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, 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 http://twitter.com/immunetics.


Tuesday, October 18th, 2011

Immunetics, Inc. to Present Novel, Rapid Test for Bacterial Contamination of Platelets at American Association of Blood Banks (AABB) Annual Meeting

Boston, Mass. — October 18, 2011 — Immunetics, Inc. announced plans to present a novel, rapid test for bacterial contamination of platelets at the American Association of Blood Banks (AABB) Annual Meeting, Oct. 21st-25th, in San Diego.

Bacterial contamination of platelets has been identified as the #1 infectious risk of transfusion, with approximately 1 out of 2,000 platelet units contaminated. Transfusion of bacterially contaminated platelets poses a significant health risk, potentially resulting in serious to fatal illness in the recipient. Traditional methods for detecting bacteria are based on inoculation of platelet samples into culture bottles followed by a 24-72 hour waiting period. In addition to the lengthy incubation period, recent studies have shown these methods to be prone to both false positive and false negative results. Culture testing has been routine for single donor platelets but is not practical for pooled whole blood-derived platelets, which must be used within 4 hours of pooling. About five million platelet units are collected annually in the United States along with an equal number in other countries.

Immunetics’ BacTx® rapid test can detect bacterial contamination by clinically relevant species in less than one hour, at levels below those shown to be harmful to transfusion recipients.

Multi-center clinical trials have been concluded in which the performance of the BacTx test was evaluated on whole blood-derived random-donor platelet units.

The results of these studies, and implications for other studies, will be presented and discussed by two clinical investigators at the AABB Meeting in a breakfast workshop entitled “BacTx – A Novel Method for the Detection of Bacteria in Platelets,” on Monday, Oct. 24, 2011, at 7:00-8:15 a.m., in Room 29 C/D in the San Diego Convention Center. The presenters are: W. Andrew Heaton, M.D., Sr. Director of Transfusion Medicine, NSLIJ Health System and Michael R. Jacobs, M.D., Ph.D., Director, Clinical Microbiology, University Hospitals, Case Medical Center. The BacTx test is currently under pre-market review by the FDA.

For more information, contact Immunetics (http://www.immunetics.com) at 617-896-9100 or 800-227-4765, or visit Immunetics at booth # 643 at the AABB Annual Meeting.

About Immunetics

Immunetics Inc. (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and blood screening, 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 http://twitter.com/immunetics.

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Press contact: Don Goncalves, Tiziani Whitmyre public relations, 781-793-9380, dgoncalves@tizinc.com


Tuesday, May 31st, 2011

Immunetics Receives $500,000 from Massachusetts Life Sciences Center to Commercialize BacTx® Test for Bacterial Contamination in Platelet Transfusions

Immunetics, Inc., today 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.

About Immunetics, Inc.

Immunetics Inc. (http://www.immunetics.com), offers state-of-the-art assay technology for infectious disease diagnosis and pathogen detection, and for over 10 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, Mass. Follow Immunetics on Twitter at http://twitter.com/immunetics.

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Press Contact: Don Goncalves, Tiziani Whitmyre, 781-793-9380, dgoncalves@tizinc.com


Tuesday, May 3rd, 2011

Immunetics Awarded $2.4 Million NIH Grant for Clinical Trials of New Blood Test for Chagas’ Disease

immunetics-release-logoBOSTON – May 3, 2011Immunetics, Inc. today announced it has been awarded a $2.4 million, 3-year Phase II SBIR grant by the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health (NIH), to support clinical trials of the company’s new confirmatory test for Chagas’ disease, a serious and potentially fatal parasitic infection.

Chagas’ disease is endemic in large parts of Latin America, where it affects up to 11 million people, and has emerged in the U.S., where more than 300,000 people are infected, according to the Centers for Disease Control and Prevention. The disease is difficult to diagnose, and is often silent for years before clinical symptoms appear. During this time, carriers can pass on the parasite through blood donations and infect transfusion recipients.

Existing screening tests that detect antibodies to the parasite are frequently inaccurate. A complex method called radioimmunoprecipitation (RIPA) is sometimes used to confirm screening test results, but is beyond the reach of most laboratories. There are no FDA-approved confirmatory test methods.

Immunetics’ test, called an immunoblot, detects antibodies to the parasite and is based on the same technology used in confirmatory tests for HIV and several other bloodborne infections. Data presented by Immunetics at meetings in 2010 of the American Association of Blood Banks and the American Society of Tropical Medicine and Hygiene showed the immunoblot test to be as accurate as RIPA in preliminary studies, said Dr. Andrew Levin, president and scientific director, Immunetics.

“The new NIH grant will enable Immunetics to undertake a full-scale clinical trial to obtain data to submit to the FDA for approval of the immunoblot as a confirmatory test. Immunetics will undertake the studies with collaborators at Blood Systems Research Institute, the American Red Cross, and the Centers for Disease Control and Prevention,” Levin said.

“This grant award gives us the opportunity to take our Chagas’ immunoblot test through the clinical studies needed to establish its validity as a confirmatory test. We are very grateful for NIH support for this project, which will allow us to bring forward a practical solution to one part of the growing public health and blood safety problem that Chagas’ disease presents in the U.S. and Latin America,” he said.

About Immunetics, Inc.

Immunetics Inc., (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and pathogen detection, and for over 10 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 better, cost-efficient care through more accurate diagnosis. Immunetics is headquartered in Boston, Mass. Follow Immunetics on Twitter at http://twitter.com/immunetics.

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Press Contact: Don Goncalves, Tiziani Whitmyre, 781-793-9380, dgoncalves@tizinc.com


Wednesday, March 30th, 2011

Immunetics Featured at Boston Startup America Event

immunectics1BOSTON, MASSACHUSETTS, March 30, 2011 - “Immunetics came to the South Boston Innovation District after recognizing that an attractive business location with talented people, reasonable facility costs, and access to capital would be a great place to achieve their next stage of growth,” Mayor Menino said. “Now, the city’s partnership with Immunetics has generated benefits that exceeded all of our expectations. Together, we’ve created jobs, won millions of dollars in grants and contracts, and most importantly, achieved medical advances that will help millions of people overcome life-threatening diseases.”

Immunetics President and Chief Executive Officer Dr. Andrew Levin said LifeTech Boston, the Mayor’s program that supports the life sciences industry in the city and is administered through the Boston Redevelopment Authority, helped locate a facility that could support the company’s growth objectives, plus secure a loan to finance its build-out.

“Since then, we have almost tripled the size of our workforce, won over $22 million in grants and contracts, and developed better diagnostics for diseases such as HIV, Lyme disease, and other serious infections that threaten our blood supply,” said Dr. Levin. “Our move to the Innovation District has been the key to Immunetics’ growth and success over the past 7 years.”

The Startup America initiative’s goal is to increase opportunities for entrepreneurs by expanding access to capital, developing education and mentorship programs, and improving collaboration between startup and established companies.

About Immunetics
Immunetics (http://www.immunetics.com) offers state-of-the-art assay technology for infectious disease diagnosis and pathogen detection. For over 10 years, the company has been a leading innovator of tests for bacterial, viral, and parasitic diseases. Immunetics produces and markets a range of infectious disease assay kits and instruments. Its mission is better, cost-efficient care through more accurate diagnosis.


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