InGen BioSciences Group, Exclusive Distributor for Cylex Incorporated in France, Reinforces its Translational Medicine …

By | Jun 14, 2012
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CHILLY-MAZARIN, France, June 14, 2012 /PRNewswire/ —

InGen BioSciences, specialised in the development and commercialisation of mono and multiparametric in vitro diagnostic tests announced a new exclusive partnership with Cylex Incorporated (Columbia, Maryland, US), a global life sciences company focused on in vitro diagnostic products intended to illuminate immunity.

With this exclusive partnership with Cylex, InGen BioSciences will provide to the French medical community the only FDA-cleared, CE marked and IVDD compliant assay that detects changes in global immune function over time in patients undergoing immunosuppressive therapy for organ transplant: ImmuKnow®.

Organ transplantation is an effective therapy for end-stage organ failure and is widely practised around the world. Global Observatory on Donation and Transplantation (GODT) 2010 data (produced by the WHO-ONT collaboration) report 106879 total solid organ transplants per year of which 73179 kidney transplants , 21 602 liver transplants and 5 582 heart transplants(1).

Studies show that long-term use of immunosuppressants is associated with significant morbidity and mortality in transplant recipients and current monitoring systems of immunosuppression in those patients are typically focused on prevention of clinical toxicities of immunosuppressive drugs.  Minimising the risk of infection and rejection in post-transplant patients is therefore crucial and challenging for clinicians.(2-5)  Unfortunately, these strategies are often not tailored to the individual and do not determine the optimal level of immunosuppression for these patients.(3)

ImmuKnow, is an innovative platform, using a small blood sample, to simply and reproducibly assess immune cell function, providing medical professionals with crucial insight for individualised allograft transplant patient management allowing them to better tailor immunosuppressant drug regimens to prevent organ rejection while avoiding infection.

“Cylex is a global life sciences company leading in vitro diagnostic assays that measure cellular immune function and ImmuKnow is an established, accepted technology that is critical to providing better patient care” says Brad L. Stewart, President and CEO of Cylex. “This distribution partnership with InGen BioSciences represents an exciting opportunity for offering the best possible services to French transplant professionals seeking to provide individualised management for their patients.”

 “We are very proud of this exclusive partnership with Cylex which reinforces our innovative offerings in immunology, complements our HLA IVD portfolio and strengthens our positioning in integrated, concrete best-in-class solutions for present and future needs of healthcare professionals in the rapidly evolving field of diagnostics”, comments Isabelle Buckle, CEO of InGen BioSciences.  “With our partners ONE LAMBDA and now CYLEX, we respond to transplant specialists needs of diagnostic tools for assessing donor-recipient matching as well as a personalised monitoring of transplanted patients.”

Since its foundation in 2001, InGen BioSciences has experienced 19 percent compound growth (CAGR) and counts 65 employees (of whom 15% are dedicated to R&D). Its first proprietary product, BJI InoPlex™, a non-invasive and easy to use tool for detection of infections in pre-and post-operative implants for orthopaedic surgeons, infectious diseases specialists and other healthcare professionals, was launched in 2011.

1. 2010 Estimates from the Global Observatory on Donation and Transplantation. http://www.transplant-observatory.org/Pages/Uses-of-Data.aspx last visited  May 30th 2012. 2.FishmanJ A. Infection in solid-organ transplant recipients. N Engl J Med. 2007;357:2601-2614.. 3. Cainelli F., Vento S. Infections and solid organ transplant rejection: a cause-and-effect relationship? The Lancet Infectious Diseases,2002 ;  2: Issue 9, :  539-549 4. Kowalski, R J.; Post, Diane R.; Mannon, Roslyn B. et al. Assessing Relative Risks of Infection and Rejection: A Meta-analysis using an Immune Function Assay. Transplantation 2006 ; 82 – Issue 5: 663-668.  5. Cabrera R, Ararat M, Soldevila-Pico C, et al. Using an immune functional assay to differentiate acute cellular rejection from recurrent hepatitis C in liver transplant patients. Liver Transpl. 2009;15:216- 222.

Notes to Editors

About the InGen BioSciences Group

The ambition of excellence.

The InGen BioSciences Group, a flexible, reactive, client centric company striving for optimum innovation (products and services) to meet the needs of biologists for their patients – develops and markets (proprietary or licensed) advanced in vitro  diagnostic kits and automats for clinical use.

  • The company’s primary focus is on infectious diseases, transplant diagnostics, auto-immunity, quality control products and rapid tests including its proprietary product Tétanos Quick Stick®.
  • Turnover reached 23.3 M€ in 2011.
  • InGen Biosciences supplies with seamless services a large selection of high-performing reagents combined with platform analysis to roughly 750 European customers. Its current customers are hospitals, private laboratories, blood transfusion services and research laboratories.
  • InGen, the distribution part of the Group, has historical footprint in France, Italy, Belgium, Switzerland and strong brand recognition in Europe with 25 longstanding partnerships.
  • The Group’s R&D arm, IBS, specialises in the development of mono and multiparametric tests using proteomics technologies  – IBS brings to market clinically relevant , innovative,  CE marked and IVDD compliant assays that are minimally invasive, fast, cost-effective. Over 15 patent families, 39 patent applications are currently registered.
  • The group is ISO 9001 (2008) and 13485 (2004) certified.
  • Sustainable strategic alliances are keys for InGen BioSciences Group to pursue its mission in delivering innovative solutions to unsolved matters worldwide with IVD companies for product distribution, acquisitions & geographic expansion or with academics, biotech and pharma for companion tests, in-licensing, co-development & in-house development of proprietary technologies.

For more information please visit: http://www.ingenbiosciences.com

About Cylex

Originally founded in 1992, Cylex is a venture-backed global life sciences company based in Columbia, MD USA. Cylex develops, manufactures and commercializes in vitro diagnostic products intended to illuminate immunity. The Company received certification to ISO 13485:2003 and 9001:2000, signifying compliance with internationally recognized standards in design, development and manufacturing of medical products. Cylex experienced exponential growth in recent years and holds a robust portfolio of patents issued in North America, Europe and Asia.

Cylex’s first FDA-cleared product, ImmuKnow, represents patented technology designed to give clinical researchers insight for individualized patient management. Combined with individual patients’ clinical factors and other routine monitoring tests, the ImmuKnow assay results help guide decisions in therapy to avoid over- or under-immunosuppression. ImmuKnow is currently sold in 18 countries.

For more information, visit http://www.cylex.net.

About ImmuKnow®

The Cylex ImmuKnow assay uses only 1 ml blood to provide rapid assessment of global immune function in organ transplant patients.

The ImmuKnow assay defines three immunological response zones: strong, moderate and weak. These zones can guide physicians in patient management.

ImmuKnow detects intracellular ATP synthesis in stimulated CD4+ cells selected from whole blood by monoclonal antibody coated magnetic beads. The amount of ATP produced reflects global T cell function. The measurement of CD4+ activation reflects cellular immunity because the CD4+ lymphocytes orchestrate cell-mediated immunity through immunoregulatory signalling.

The utility of the ImmuKnow assay has been well characterized and validated:

  • Over 650,000 assays run
  • 25 prospective and interventional studies in more than 1000 transplant recipients
  • More than 120 clinical studies

1. Cabrera R, Ararat M, Soldevila-Pico C, et al. Using an immune functional assay to differentiate acute cellular rejection from recurrent hepatitis C in liver transplant patients. Liver Transpl. 2009;15:216- 222.

2. Sánchez-Velasco P, Rodrigo E, Valero R, et al. Intracellular ATP concentrations of CD4 cells in kidney transplant patients with and without infection. Clin Transplant. 2008;22:55-60.

3. Bhorade SM, Janata K, Vigneswaran WT, Alex CG, Garrity ER. Cylex ImmuKnow assay levels are lower in lung transplant recipients with infection. J Heart Lung Transplant. 2008;27:990-994.

4. Husain S, Raza K, Pilewski JM, et al. Experience with immune monitoring in lung transplant recipients: correlation of low immune function with infection. Transplantation. 2009;87:1852-1857.

5. Kiyosaki K, Kobashigawa J, Patel J, et al. The benefit of immune monitoring (Cylex): a review of 864 immune monitoring assays in heart transplantation. Presented at: The International Society for Heart and Lung Transplantation 29th Annual Meeting and Scientific Sessions; April 22-25, 2009; Paris, France; Abstract 511.

6. Humar A, Michaels M. American Society of Transplantation recommendations for screening, monitoring and reporting of infectious complications in immunosuppression trials in recipients of organ transplantation. Am J Transplant. 2006;6:262-274.

7. Augustine NH, Pasi BM, Hill HR. Comparison of ATP production in whole blood and lymphocyte proliferation in response to phytohemagglutinin. J Clin Lab Anal. 2007;21:265-270

Media contacts

For any further information please contact:

Bahar Turkoglu, CCA France, bturkoglu@ccapr.com or +33(0)1-41-43-02-27

Here in new england

By | May 22, 2012
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State considers wind turbine noise regulations

BOSTON State environmental officials are considering new regulations that would require state review to determine if proposed wind turbines would be too noisy in generating power.

The Boston Globe reported Monday that state officials might also conduct sound studies in Fairhaven and Kingston, where residents have complained about noise from existing turbines. Last week, officials in Falmouth shut down a town-owned turbine after the state Department of Environmental Protection found it made too much noise at a nearby residence.

DEP Commissioner Kenneth Kimmell said the Falmouth measurements, plus a previous recommendation in favor of such testing from an independent panel, have the state giving serious consideration to implementing additional procedures to limit noise impacts.

He said the possible new regulations could require manufacturers to report the expected noise levels to turbine operators. The state could then use computer models to predict their noise at various distances, Kimmell said.

Such modeling is standard practice for facilities that generate a lot of noise, such as power plants that use fossil fuels, Kimmell said. But he said the state, to date, has mainly left such testing to local permitting boards.

Portland waters searched for Harvard student
PORTLAND, Maine Divers on Monday recovered some clothing belonging to a Massachusetts man who disappeared after he was asked to leave a pub while celebrating his upcoming graduation from Harvard Business School, police said.

Nathan Bihlmaier, 31, of Cambridge, was celebrating with two classmates when a worker at the waterfront pub asked him to leave at 12:20 a.m. Saturday because he was visibly intoxicated, Police Chief Michael Sauschuck said. Bihlmaier failed to return to his hotel and was reported missing on Sunday.

Divers on Monday found an article of clothing belonging to Bihlmaier and planned to return to harbor waters on Tuesday. A sonar device was brought in for the search.

But Sauschuck said Monday that investigators continue to look at all scenarios not just the possibility that Bihlmaier fell into the water late Saturday.

Bihlmaier, whose wife is pregnant with their first child, is due to graduate with his classmates on Thursday.

After being asked to leave the Ri Ra Irish Pub near the Maine State Pier, Bihlmaier called his friends several times from his cell phone up until 1 a.m., when the calls stopped. He appeared to be lost and was naming landmarks in hopes that he could rendezvous with his friends, the chief said.

Medical society opposes medical marijuana
BOSTON The states largest doctors organization is taking a stand against a proposed ballot question that would allow marijuana use for medical reasons.

The Massachusetts Medical Society approved a resolution at its annual meeting this past weekend opposing legalization of medicinal marijuana without scientific studies proving it would be safe and effective.

The organizations House of Delegates also backed a second resolution opposing any legislation that would involve doctors prescribing marijuana to patients except for scientific studies or clinical trials.

The group representing about 24,000 doctors did call on the U.S. Drug Enforcement Administration to reclassify marijuana to permit more studies on its possible medical benefits.

The question proposed for the November state ballot would allow patients with debilitating medical conditions to get permission from their doctors to use marijuana.

Dental chain chief surrenders licence in NH
CONCORD, N.H. The president of a bankrupt dental chain that abruptly closed offices in 13 states last year has surrendered his license to practice dentistry in New Hampshire.

New Hampshire authorities received more than 140 complaints from patients, after Allcare Dental shut down its two offices in New Hampshire and dozens more in other states, including Massachusetts. Many had had their teeth extracted and were waiting for permanent dentures they never received.

Though he never worked in New Hampshire, Allcare president Robert Bates faced a disciplinary hearing in the state. Instead, he agreed to surrender his license and acknowledged that neither he nor Allcare informed patients about the closing or helped them afterward.

App allows MBTA riders to report suspicions
BOSTON A new smartphone app allows MBTA riders to instantly alert transit police to any suspicious activity they witness.

The free, downloadable iPhone app, unveiled Monday, provides two options for contacting authorities. A button called Report a Problem on the apps home screen allows riders to send text messages or photos to MBTA police.

A separate, Call Transit Police button allows users to speak directly to police.

The app is part of the Ts See Something, Say Something program that encourages riders to report suspicious packages or any activity that seems out of line.

Customers can also sign up to receive notifications from the T about service delays or disruptions.

Ex-officer faces trial in death of teen bicyclist
HARTFORD Jury selection has begun in the manslaughter trial of a former Windsor Locks police officer charged in an off-duty accident that killed a teenager on a bicycle.

The prosecution and defense in the case of Michael Koistinen, 26, began choosing jurors Monday in Hartford Superior Court after a lawyer for Koistinen entered a not guilty plea.

Police say Koistinen struck Henry Dang, 15, in Windsor Locks on the night of Oct. 30, 2010. Authorities say Koistinen had been drinking and was speeding when he hit the Windsor Locks High School sophomore.

Koistinen was later fired. His father, former Windsor Locks police Sgt. Robert Koistinen, also was fired and awaits trial on a charge of hindering the investigation.

From Associated Press reports

Allcare Dental owner surrenders his NH license

By | May 22, 2012
Comment

Published

May 22, 2012

at 3:00 am (Updated May 21, 2012)

CONCORD — The man who headed Allcare Dental, which shut down offices in 13 states without notice Jan. 1, 2011, has surrendered his license to practice dentistry in New Hampshire. Allcare’s New Hampshire offices were in Manchester and Nashua.

Attorney General Michael Delaney said Robert Bates, who incorporated Allcare in New Hampshire in 2006, shortly after obtaining a New Hampshire dental license, surrendered his license as part of a consent decree signed May 9.

Bates was president of Allcare Dental Management LLC and Allcare Dental and Dentures of NH PC. His license surrender, approved by the New Hampshire Board of Dental Examiners. resolves allegations of professional misconduct that were scheduled for a disciplinary hearing before the board.

Patients learned of the closures when they arrived for appointments and found a note on the door that the offices were closed.

Allcare, which was based in the Buffalo, N.Y., area, filed for chapter 7 bankruptcy protection (liquidation) in U.S. Bankruptcy Court in Buffalo in November 2011.

After Allcare closed, the New Hampshire Department of Justice and the Board of Dental Examiners received more than 143 complaints from patients who had incomplete dental treatment discontinued.

At the time of the closing, many of the patients had had their teeth extracted and were waiting for permanent dentures they never received. Many of them had prepaid for dental care they did not receive, with one patient telling the New Hampshire Union Leader that if patients did not have the money available, Allcare arranged loans for them.

Under New Hampshire law, Dr. Bates was “practicing dentistry” even though he did not treat patients in the state and was therefore responsible for his and Allcare’s failures to fulfill various legal and ethical duties arising when a dental practice closes.

Under the consent decree, Bates acknowleged that he and Allcare failed to inform patients prior to the closure, that neither he nor Allcare provided any further treatement to Allcare patients after the closure, and that he and Allcare failed to be available to provide emergency care to patients following the closure.

Bates has also been the subject of actions taken by the dental licensing boards of Massachusetts, West Virginia and North Dakota. In 2010, the company paid $135,000 to Pennsylvania to settle a lawsuit the state filed against it.

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