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Wednesday, December 5th, 2012

“Processing Compounded Sterile Products,” Information Session Set for Dec. 12 in Springfield, Mass.

AGAWAM, MASS. — Dec. 5, 2012 — A free information session focusing on the challenges of meeting U.S. regulations mandating tighter control of sterile preparations in compounding pharmacies, has been scheduled for Dec. 12, 2012, in Springfield, Mass.

The session, “Processing Compounded Sterile Products,” will be presented by Microtest Laboratories, a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries.

Designed for managers of controlled environments in the pharmaceutical industry, experts in the session will offer technical presentations, practical advice, and solutions on issues relating to General Chapter <USP 797>, including:

  • Environment contamination control and testing
  • FDA aseptic guidance
  • USP <797> and <1116>
  • Technician training and qualification requirements
  • Product testing that includes: sterility/endotoxin, potency/ID, beyond use dating
  • Assessing current practices and next steps

“Processing Compounded Sterile Products” is scheduled for Wednesday, December 12, 2012, at the Hilton Garden Inn, 800 Hall of Fame Avenue, Springfield, Mass., from 9:30 to 11:30 a.m. Registration is at 9 a.m. The session is free — complimentary entry, parking, and refreshments will be provided — but space is limited and advance reservations are required. For more information or to reserve admission, visit the Microtest Laboratories website at http://www.microtestlabs.com/pdfs/seminar-registration-form_1212.pdf, call 1-800-631-1680 extension 192, or email jadamski@microtestlabs.com.

Microtest Laboratories is a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest’s environmental sciences group helps its clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Posted in Biosciences, Health/Medical, Life Sciences |


Monday, November 26th, 2012

Immunetics, Inc. Names John Yonkin as CEO

Boston, Mass. — November 26, 2012 — Immunetics, Inc., an innovative developer of state-of-the-art assay technology for infectious disease diagnosis and blood screening, today announced that the company’s Board of Directors has appointed John Yonkin as Chief Executive Officer.

Mr. Yonkin will assume the post of CEO effective December 1, 2012. He will also serve as a member of the Board of Directors.

Mr. Yonkin brings more than 25 years of business experience in the clinical diagnostics field to Immunetics. Previously, he served as Vice President for Strategic Projects at Alere, Inc., and as President of Alere’s predecessor, Inverness Medical Innovations. While at Alere, he was the lead executive responsible for the integration of Biosite, Inc., following its acquisition by Alere in 2007. At Inverness, Mr. Yonkin was President of Nutritionals and Pharmaceuticals from 2005-2007, and Vice President of U.S. Sales and Marketing from 2001-2005. His previous experience includes positions managing sales and marketing and product development at Baxter, Genzyme, and Inverness.

“I am very excited to be joining the very talented scientific team at Immunetics as the company prepares to bring to market the innovative BacTx® rapid test for bacterial contamination of platelets,” Mr. Yonkin said.

The BacTx test addresses a critical, global infectious risk in transfusion, caused by the  estimated 1 in 2,000 platelet units that are contaminated with bacteria. Medical studies are increasingly showing that such contamination is a significant cause of illness and death among transfusion recipients. Worldwide, more than 10 million platelet units are collected per year.

Immunetics received U.S. Food and Drug Administration (FDA) clearance for its BacTx test in June 2012. The company has issued patents on the BacTx technology, which was initially developed with support from the National Institutes of Health.

Mr. Yonkin succeeds Dr. Andrew Levin, the company’s founder. Dr. Levin will remain President at Immunetics and will continue to lead the Research and Development group.

About Immunetics

Immunetics, Inc. 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 produces and markets a range of infectious disease assay kits and instruments. The company has issued patents on its BacTx® test for bacterial contamination of platelets. It 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. Immunetics is headquartered in Boston. The company’s mission is to deliver better, cost-efficient care through more accurate diagnosis. For more information, visit the Immunetics website at http://www.immunetics.com.

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Posted in Biosciences, Life Sciences |


Wednesday, October 24th, 2012

New White Paper Assists Medical Device Manufacturers with Changes to FDA Endotoxin Testing Guidelines

AGAWAM, MASS. —October 24, 2012 — A new white paper is available to assist medical device manufacturers with understanding recent changes to the U.S. Food and Drug Administration’s (FDA) thinking regarding endotoxin testing. The paper is available to download from the Web at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper.

Titled “FDA Updates Medical Device Endotoxin Testing Program (New Guidance),” the new white paper is authored by Steven G. Richter, Ph.D., a former FDA official, and President and Chief Scientific Officer of Microtest Laboratories, Inc., a leading contract testing laboratory.

In the paper, Dr. Richter discusses the FDA’s recently published document, “Guidance of Industry Pyrogen and Endotoxin Testing: Questions and Answers.” The FDA document replaced the agency’s 1987 Endotoxin Guidelines — now considered out of date as a result of changes in the USP and pharmaceutical dosage forms. It presents the agency’s current position regarding pyrogen and bacterial endotoxin testing requirements for pharmaceuticals, biologics, and medical devices. Medical devices that contact circulating blood or cerebrospinal fluid, or are used with intraocular products or in vitro fertilization procedures, are required to be endotoxin-free.

In his new white paper, Dr. Richter reviews the FDA’s updated guidelines on endotoxin testing and explains how they relate to medical devices. Since the majority of pyrogens found on medical devices are bacterial in nature, the paper focuses on those contaminates.

Some medical devices that are required by the FDA to be tested for endotoxin are:

  • Intravenous catheters and tubing
  • Cardiac stents and angioplasty balloons
  • Certain implants such as pacemakers/defibrillators
  • Spinal catheters
  • Transfusion catheters
  • Intraocular lens implants
  • Cranial drills
  • Perfusion tubing
  • Dialysis tubing and filters
  • Vascular grafts
  • In vitro fertilization catheters

Download a copy of the new white paper, “FDA Updates Medical Device Endotoxin Testing Program (New Guidance),” from the Microtest Laboratories website at http://www.microtestlabs.com/medical-device-endotoxin-testing-paper. Or, request a copy by calling 1-413-786-1680 or toll-free 1-800-631-1680.

About Microtest Laboratories

Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com, or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow on Twitter at http://twitter.com/MicrotestLabs.

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Posted in Biosciences, Health/Medical, Manufacturing |


Tuesday, October 2nd, 2012

Leading Physicians to Discuss “Advances in Bacterial Testing of Platelets: BacTx Field Experience” at American Association of Blood Banks (AABB) Annual Meeting

Boston, Mass. — October 2, 2012 — Bacterial contamination of platelets is the greatest infectious risk of blood transfusion today — and preventing it has become a priority for transfusion safety.

Two leading physicians will discuss their experience with Immunetics’ BacTx® rapid test — which addresses that priority and which can detect bacterial contamination by clinically relevant species in less than one hour — at the upcoming AABB Annual Meeting on Oct. 8th in Boston.

BacTx was FDA cleared in June 2012 as a quality control test for up to 6 units of leukocyte-reduced whole blood-derived platelets pooled within 4 hours of transfusion. The clearance was based in part on the results of clinical trials presented by 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 two physicians will discuss their clinical trials at the AABB workshop titled, “Advances in Bacterial Testing of Platelets: BacTx Field Experience,” on Monday, Oct. 8, 2012, from 7 a.m. to 8:15 a.m. in Room 253A of the Boston Convention Center.

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

For more information, about the BacTx rapid test for bacterial contamination in platelet units, visit Immunetics at booth #662 at the AABB Annual Meeting & CTTXPO 2012, Oct. 6 to 9, 2012, in the Boston Convention Center, Boston. Or, visit the Immunetics website at http://immunetics.com/bactx.html, or call 1-617-896-9100 or toll-free 1-800-227-4765.

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.

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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Posted in Biosciences, Health/Medical |


Tuesday, October 2nd, 2012

New Scope of Reusable Medical Device Cleaning Validations is Examined in New White Paper from Microtest Laboratories

AGAWAM, MASS. – October 2, 2012 – The new scope of cleaning validations for the manufacturers of reusable medical devices is examined in a white paper available for download from http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

“Cleaning validation for reusable medical devices is an important step in proving their safety. Available guidance documents now indicate that the traditional method of validating cleanliness, spore log reduction, will no longer be acceptable. Analytical assays capable of providing quantitative results will now be required instead,” writes white paper author Patrick Kenny, Manager of Analytical Services, Microtest Laboratories.

In the new white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” Kenny notes that “although a new requirement for reusable medical devices, these tests are traditional analytical assays that are performed routinely on other types of samples.”

“An effective protocol and report that includes justifications for the test soil and assays chosen, as well as thorough documentation of all parameters used in the validation, will help ensure success for the device’s submission,” Kenny notes.

The paper discusses cleaning validation analytical assays as well as various methods and scenarios related to performing the validation. Recommendations are based on several key documents relating to reusable device cleaning validations that are either in draft or final form. They include AAMI document TIR30:2003, a comprehensive guide to medical device cleaning validations. TIR30 is currently in revision, and an updated version is scheduled for 2011 release.

Download the white paper, “The New Scope of Reusable Medical Device Cleaning Validations,” from the Microtest Laboratories website at http://www.microtestlabs.com/new-scope-cleaning-validation-paper.

Kenny holds a M.S. degree in Chemistry and has spent the past 13 years working in QC, R&D and manufacturing laboratories. At Microtest, Kenny leads the services group performing medical device and pharmaceutical analytical testing for companies worldwide.

About Microtest Laboratories

Microtest Laboratories is a full-service medical device testing laboratory and provider of related services for the medical device, pharmaceutical, and biotechnology industries. Medical device testing is performed in-house by seasoned regulatory microbiologists and chemists under strict GMP/GLP regulations. Microtest is both ISO 9000 and 17025 certified. Testing services include bioburden, sterility, endotoxin, accelerated aging, and toxicity (ISO 10993). In addition, Microtest recently introduced a fast-track test to screen plastics and polymers in medical devices for toxicity using Zebrafish embryos.

Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com, or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow on Twitter at http://twitter.com/MicrotestLabs.

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Posted in Biosciences, Health/Medical, Manufacturing |


Tuesday, September 25th, 2012

Boston Seminar to Assist Medical Device & Pharmaceutical Manufacturers with Environmental Monitoring, Risk-Assessment

Microtest Laboratories will present an environmental monitoring seminar and risk-assessment workshop to assist medical device and pharmaceutical manufacturers with building, validating, and maintaining their clean rooms and sterile manufacturing environments.

Titled “Environmental Monitoring Seminar and Risk-Assessment Workshop,” the event will provide practical information and the latest techniques on cleaning and disinfection programs designed to maintain aseptic conditions and prevent microbial contamination.

The event will be held at the MIT Endicott House in Dedham, Mass. — just outside Boston — on Wednesday, October 24, 2012, from 10 a.m. to 2 p.m.

At the event, attendees will:

  • Participate in a hands-on workshop that focuses on risk assessment in the clean room
  • Discover the best practices for qualifying and maintaining a clean room facility
  • Identify and assess the risks commonly found in a clean room environment
  • Test the information they’ve learned in a mock clean room floor plan exercise

A networking reception, and lunch, is included. For more information, or to RSVP, contact Julie Adamski at Microtest Laboratories by phone at 1-800-631-1680, ext. 192, or by email at jadamski@microtestlabs.com. Registration for the event is $149.

The event is one in a series of technical seminars and workshops for medical device and pharmaceutical manufacturers presented by Microtest Laboratories, a Mass.-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest’s environmental sciences group helps its clients maintain control of theircontrolled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at http://twitter.com/MicrotestLabs.

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Posted in Biosciences, Buildings & Facilities, Manufacturing |


Tuesday, September 18th, 2012

White Paper Helps Research Institutions Implement BSL-2+ Biosafety Programs in Laboratories

Needham, Mass. – September 18, 2012 – A new, free white paper assists research institutions with the challenges of implementing biosafety level (BSL) 2+ practices and procedures in laboratory facilities.

BSL-2+ is the term frequently used to describe laboratories where work with microorganisms is conducted in a BSL-2 laboratory with biosafety practices and procedures typically found at BSL-3. The biosafety level is determined by a risk assessment process. In some cases the risk assessment reveals that safety practices over and above those required at BSL-2 are needed, yet a more complex BSL-3 laboratory facility is not necessary.

The paper titled “A Practical Guide to Implementing a BSL-2+ Biosafety Program in Laboratories” is based on a client survey EH&E conducted of academic, biotechnology and healthcare institutions focused on how institutions are managing implementation of BSL-2+ practices in laboratories. The survey identified three areas that are most challenging:

  • Determining what work or projects require BSL-3 practices
  • Ensuring that the researchers are properly trained in the use of BSL-3 practices in a BSL-2 laboratory
  • Ensuring that a project-specific Standard Operating Procedure (SOP) is developed

“The fact that BSL-2+ is not a recognized containment level in biosafety guidance documents makes it challenging for research institutions to determine when to use this hybrid approach and which biosafety practices to use,” says Betsy Gilman Duane, Associate Director of EH&S Compliance / Biosafety Practice Leader of EH&E. “Unlike biosafety levels-1, 2, 3, and 4, BSL-2+ is not a prescribed containment level. We’ve found that there is limited information available on this topic and developed the paper to serve as an additional resource for research institutions looking to create a BSL-2+ laboratory facility.”

The paper, “A Practical Guide to Implementing a BSL-2+ Biosafety Program in Laboratories”, addresses the challenges identified in the survey and discusses the critical steps to implementing a BSL-2+ laboratory.

Download the white paper “A Practical Guide to Implementing a BSL-2+ Biosafety Program in Laboratories” at http://www.eheinc.com/BSL2plus_guide.htm

Or, for more information contact EH&E directly on the web at: www.eheinc.com or by phone at 800-825-5343.

About EH&E

EH&E (www.eheinc.com) has provided an extensive range of environmental and engineering consulting services for 25 years. The EH&E team consists of more than 60 experts with an outstanding record of providing business-focused solutions for issues that affect the built environment. EH&E has a depth of knowledge and credibility unmatched in the industry.  The firm’s wealth of readily-accessible information is a powerful resource for its clients.

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Posted in Biosciences, Health/Medical |


Monday, September 10th, 2012

Immunetics Receives $3.7 Million NIH Contract for Babesia Blood Screening Test

— Will Carry Out Clinical Trials with Blood Systems Research Institute,
Creative Testing Solutions —

BOSTON — September 10, 2012 — Immunetics, Inc., has received a $3.7 million, two year SBIR contract from the National Heart, Lung and Blood Institute, an agency of the National Institutes of Health (NIH), to support clinical trials of a new blood screening test for Babesia infection.

“Babesia is among the top infectious threats to blood safety and, at present, there is no licensed test available. The NIH contract will allow us to address this gap in blood safety with the first cost-effective test designed for high-throughput screening of the blood supply.  We are honored to have been entrusted by NIH to carry out this public health mission,” said Andrew E. Levin, Ph.D., Immunetics Chief Executive Officer and Scientific Director.

Babesia is a parasite which is transmitted by the same ticks that transmit Lyme disease. While it is often asymptomatic in healthy people, Babesia infection can lead to severe or fatal illness, especially in immunocompromised patients. The parasites can remain viable in blood donations and infect transfusion recipients. In recent years, nine fatal cases of transfusion-transmitted babesiosis have been reported. Surveillance carried out by the Centers for Disease Control and Prevention (CDC) revealed over 1,000 cases of infection nationwide in 2011 — a number that appears to be growing. The US Food & Drug Administration (FDA) sponsored a workshop in 2008 focused on Babesiosis as an emerging threat to the blood supply, and the Blood Products Advisory Committee convened a meeting in 2010 to advise the FDA on approaches to blood screening for Babesia.

The contract award will enable Immunetics to bring its Babesia test, developed under initial NIH support, through clinical trials and regulatory licensure. The trials will be carried out in collaboration with Blood Systems Research Institute of San Francisco, Calif., and Creative Testing Solutions of Tempe, Ariz. Creative Testing Solutions currently tests about 25% of the US blood supply, including regions endemic for the parasitic agent. The Babesia test will initially be made available through Creative Testing Solutions’ laboratories.

“We look forward to partnering with Immunetics and BSRI in the development and FDA approval process of a Babesia assay for use in blood screening,” said Creative Testing Solutions President Sally Caglioti. “It is always our intent to offer innovative services that provide our customers with the best donor testing possible. Active collaboration in the development of diagnostic tests that fit the immediate needs of the blood banking community is the next logical step to support CTS’ mission.”

“When the screening test identifies antibody-reactive donors, we will enroll and conduct rigorous testing of donation-derived and follow-up samples from those donors so that we can more fully understand the natural history of Babesia infection in asymptomatic donors,” said Michael P. Busch, M.D., Ph.D., Blood Systems Research Institute Director and Senior Vice President for Research and Scientific Affairs at Blood Systems. “The information that we derive will help guide the development of policies on how the test can be used most effectively. It will also determine whether and how donors who have had a positive result on the screening test could safely donate in the future.”

For more information, visit the company’s website at http://www.immunetics.com or call 1-617-896-9100 or toll-free 1-800-227-4765.

Immunetics is a leading developer and provider of innovative tests for a variety of bacterial, viral, and parasitic diseases. Recently, the company received FDA clearance for its BacTx® test for bacterial contamination in platelets. The company has developed and markets other FDA-cleared products, including a test for Lyme disease, and is actively working on new tests for HIV and Chagas disease — both of which are known or emerging risks to the blood supply.

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.

About Creative Testing Solutions

Creative Testing Solutions (www.myCTS.org), a joint venture of Blood Systems and Florida-based OneBlood, is the largest independent blood donor testing laboratory in the United States, specializing in high-volume blood donor testing and infectious disease reference work. This non-profit organization, headquartered in Tempe, Arizona, tests nearly 4.5 million samples annually at three national laboratories in Dallas, Phoenix and Tampa that, combined, provide testing for more than 25 percent of the U.S. blood supply.

About Blood Systems

Blood Systems (www.bloodsystems.org) is one of the nation’s oldest and largest non-profit community blood service providers and operates community blood centers serving more than 500 hospitals in 18 states, biological products distribution services, a quality consulting group and a world-renowned transfusion medicine research institute.

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Posted in Biosciences, Health/Medical, Life Sciences |


Tuesday, July 31st, 2012

Six Critical Areas to Ensure Regulatory Compliance in Aseptic Manufacturing are Outlined in New Management Brief

AGAWAM, MASS. — July 31, 2012 — An unscheduled inspection of an aseptic manufacturing process can hit a pharmaceutical company with the fury of a New England nor’easter. But a new management brief explains how a best-practice control and monitoring system can minimize the danger of FDA noncompliance. The brief is available for download from http://www.microtestlabs.com/weathering-the-storm-brief.

In the aseptic manufacturing business, all processes must be best practice to ensure the process will comply with the regulations. If any are poorly designed, not utilized, or deviated from, then the entire aseptic manufacturing system is considered out of compliance. This means that the checks and balances of a quality system must ensure that the sterile environments and surrounding support SOPs truly are working and show no signs of trending towards failure.

The new management brief, “Weathering the Storm of Regulatory Compliance in Aseptic Manufacturing,” outlines six critical areas that should be addressed to avoid the possibility of product contamination:

  • Training and professional development
  • Environmental monitoring (EM) procedures
  • Incorporation of single-use technology (e.g. needle/tubing sets)
  • Facility design and maintenance
  • Process simulation
  • Raw material control, preparation, and sterilization

“The FDA has been very critical of aseptic fill/finish companies whose manufacturing environments are out of trend or outside of specifications,” noted management brief author Alexander (Alex) Mello, M.S., SM (NRCM), the director of Project Management, Manufacturing at Microtest Laboratories, Inc., in Agawam, MA.

“Rigorous production system control and monitoring through data generation and analysis will pave the way for best-practice pharmaceutical manufacturing,” he stated.

The new management brief discusses how. Download a copy of “Weathering the Storm of Regulatory Compliance in Aseptic Manufacturing,” from http://www.microtestlabs.com/weathering-the-storm-brief.

About Microtest Laboratories

Microtest Laboratories is a leader in testing services and contract manufacturing for medical devices, pharmaceuticals, and biotechnology. Founded in 1984, the company’s expertise and flexible processes enhance product safety and security, speed time to market, and minimize supply chain disruption. Microtest’s unique single-source capability to provide testing and manufacturing solutions allows the company to support a full pharmaceutical or medical device product release. Our facilities in Agawam, Massachusetts, include state-of-the-art aseptic manufacturing areas; analytical chemistry, microbiological, and virological laboratories; Class 100 clean rooms; onsite steam and ethylene oxide sterilization, plus depyrogenation capabilities; purified water systems; and voice/data systems. For more information, visit http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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Posted in Biosciences, Life Sciences, Manufacturing |


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.

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Posted in Biosciences, Health/Medical, Life Sciences |

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