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Researchers at Yale School of Medicine have developed a simple urine test to rapidly predict and diagnose preeclampsia, a common, but serious hypertensive complication of pregnancy.

Dubbed the “Congo Red Dot Test” by the research team, the test accurately predicted preeclampsia in a study of 347 pregnant women, allowing health care providers to offer better preventive care to pregnant women. The research was presented February 4 at the Annual Scientific Meeting of the Society for Maternal Fetal Medicine in Chicago.

“There is a critical need in the developing world for low-cost diagnostics for preeclampsia,” said lead researcher Irina Buhimschi, MD, associate professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at Yale School of Medicine. “This test will help identify high-risk patients that should be transported from remote settings to facilities where there is access to specialized care for preeclampsia, such as magnesium sulfate therapy.”

Buhimschi said that despite its effectiveness in preventing eclamptic seizures, magnesium sulfate is underutilized in developing countries. This is due in part to the lack of consistent and low-cost ways to identify preeclampsia patients who are in need of intervention, which the test could provide. She said that the test could also identify women who needed to deliver their babies immediately, in turn reducing the incidence of unnecessary early birth, because delivery is the only effective treatment for preeclampsia.

The team also found that the Congo Red Dot Test could be used as a marker for assessing misfolded proteins. The test is based on a common red dye, originally used to stain textiles, that sticks to misfolded proteins. Previous studies by Buhimschi and her team have found that preeclampsia is a pregnancy-specific protein misfolding disease.

“In this new work, we have seen a link between preeclampsia and other disorders caused by misfolded proteins such as Alzheimer’s or prion disease,” said Buhimschi. “This may provide the foundation for new therapeutic approaches to reduce the burden of this disorder.”

Pfizer Inc. and DxS, a wholly owned subsidiary of Qiagen N.V. have entered into an agreement to develop a companion diagnostic test kit for PF-04948568 (CDX-110), an immunotherapy vaccine in development for the treatment of glioblastoma multiforme (GBM).  Financial terms of the diagnostic agreement have not been disclosed.

On April 16, 2008, Pfizer and Celldex Therapeutics Inc. entered into an agreement to grant Pfizer an exclusive worldwide license to PF-04948568 (CDX-110) which is currently in Phase 2 clinical development for the treatment of newly diagnosed GBM.

Pfizer’s investigational drug PF-04948568 (CDX-110) is a peptide vaccine which targets the tumor-specific Epidermal Growth Factor Receptor variant III (EGFRvIII), a mutated form of the epidermal growth factor receptor that is only present in cancer cells and occurs in 25-40 percent of GBM tumors.  The Qiagen assay is designed to identify those patients whose tumors express the EGFRvIII mutation, allowing for the possibility of more targeted and personalized treatment.

The EGFRvIII companion diagnostic will be developed and manufactured at Qiagen’s Center of Excellence for Companion Diagnostics in Manchester, UK.  The diagnostic will be a real-time PCR assay used to detect EGFRvIII RNA in tumor tissue. The assay is designed to offer a simple workflow, which supports its clinical utility in routine mutation testing.

Commenting on this announcement, Dr. Stephen Little, Vice President Personalized Healthcare, for Qiagen, said, “We are very pleased to have signed this agreement with Pfizer, as it is another important step toward the realization of personalized medicine.  Qiagen is aligned to deliver companion diagnostics to our pharmaceutical partners and this deal is further evidence of our commitment to develop our scientific and operational capabilities to help select the right patient for the right medicine.”

“We look forward to collaborating with Qiagen’s DxS unit in the development of this important diagnostic tool that could potentially help physicians better define the most appropriate treatment for patients who suffer from glioblastoma multiforme,” said Garry Nicholson, president and general manager of Pfizer’s Oncology Business Unit.

Inverness Medical Innovations Inc. has entered into a binding agreement with Kroll Inc., a subsidiary of Marsh and McLennan Companies Inc. purchase its substance abuse testing division, Kroll Laboratory Specialists Inc., its business unit providing forensic quality substance abuse testing products and services across the United States. The purchase price is $110 million cash subject to a customary working capital adjustment.  The acquisition is expected to close in the first quarter of 2010 but remains subject to customary closing conditions.

Headquartered in Gretna, LA, Kroll Laboratory Specialists Inc. operates two laboratories certified by the industry’s benchmark, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), in Gretna, LA and Richmond, VA and had revenues of approximately $40.2 million for the year ended December 31, 2008.  These locations service workplace, occupational health, third party administrator, criminal justice, government institutions, and other markets throughout the United States.  Kroll Laboratory Specialists has more than 30 years of experience in the substance abuse testing industry. 

Commenting on the agreement, Ron Zwanziger, CEO of Inverness said, “We are very pleased to acquire Kroll Laboratory Specialists. The drugs of abuse testing market continues to demonstrate strong global growth potential, and we believe that this acquisition will deepen the range of products and services we offer the government, employers, health plans, and healthcare professionals through our existing channels.”

Home Diagnostics Inc. signed a definitive merger agreement with Nipro Corp. (Osaka, Japan), a global manufacturer and distributor of medical devices, pharmaceutical products, and medical and glass products, under which Nipro will acquire all outstanding shares of Home Diagnostics’ common stock, $.01 par value, for a cash purchase price of $11.50 per share, or aggregate consideration of approximately $215 million. The offer price represents an approximately 90% premium to the closing price of Home Diagnostics’ common stock on February 2, 2010, and an approximately 83% premium to Home Diagnostics’ average closing price for the preceding 90 days.

The two-step acquisition will be effected by means of a first-step, cash tender offer commenced by a wholly-owned subsidiary of Nipro for all of the outstanding shares of Home Diagnostics’ common stock, at $11.50 net per share in cash, followed by a second-step merger in which untendered Home Diagnostics’ shares will be acquired at the same $ 11.50 net cash price per share. All Home Diagnostics’ stock options and stock appreciation rights will receive cash equal to the excess, if any, of $11.50 over their exercise price.

The transaction has been approved by Nipro and the board of directors of Home Diagnostics. The tender offer, which will remain open for a minimum of 20 business days, subject to certain extensions as required by applicable law and the terms of the merger agreement, is subject to certain conditions, including the valid tender and acceptance for payment in the tender offer of a majority of the fully diluted Home Diagnostics common stock, the expiration or early termination of the applicable waiting period under the Hart-Scott-Rodino Act, and other customary conditions. The tender offer is not subject to a financing condition.

Certain stockholders of Home Diagnostics, owning in the aggregate approximately 15% of Home Diagnostics’ outstanding common stock, have committed to tender their shares in the offer. Home Diagnostics has also granted Nipro a top-up option exercisable under certain circumstances to enable Nipro to own 90% of the fully diluted Home Diagnostics common stock and complete the second step of its acquisition of Home Diagnostics by means of a short form merger not requiring approval by Home Diagnostics’ stockholders. Nipro has also reserved the right to commence a subsequent offering period following the expiration of the initial tender offer period if Nipro then owns less than 90% of the fully diluted Home Diagnostics common stock.

The merger agreement permits Home Diagnostics’ board, under certain circumstances prior to the completion of the offer, to enter into discussions and negotiations and furnish information to third parties who submit to Home Diagnostics unsolicited acquisition proposals which Home Diagnostics’ board of directors determines to be reasonably likely to lead to a superior offer and, thereafter, to terminate the transaction with Nipro and enter into a definitive agreement providing for a superior offer, subject to Nipro’s right to match or improve the terms of any such superior offer and further subject to the payment to Nipro of a $6,500,000 termination fee or reimbursement of certain of Nipro’s out of pocket expenses in other circumstances.

The parties expect the tender offer to commence on or about February 10, 2010. The tender offer will remain open for 20 business days from commencement, subject to extension under certain circumstances as required by applicable law and the terms of the merger agreement. Subject to the satisfaction of the conditions to the tender offer, the offer is expected to be consummated prior to the end of the first quarter of 2010.

Thermo Fisher Scientific Inc. has signed a definitive agreement to acquire Finnzymes, a provider of integrated tools for molecular biology analysis, including reagents, instruments, consumables, and kits. Headquartered in Espoo, Finland, Finnzymes has 90 employees and generated revenue of $20 million in 2009.

Finnzymes provides comprehensive solutions for high-performance polymerase chain reaction (PCR), reverse transcription-PCR (RT-PCR), and real-time quantitative PCR (qPCR). The company’s expertise in DNA polymerases has led to significant increases in the performance of these enzymes, making the PCR process faster and more accurate. The ability to quickly and reproducibly amplify and quantify particular DNA sequences benefits a variety of applications, including basic genomic research, genetic testing, forensics, and food testing.

The acquisition of Finnzymes expands Thermo Fisher’s portfolio of reagents and other consumables for the molecular biology research and diagnostics markets through the addition of its proprietary DNA polymerases, Phire, and Phusion, and high-speed miniaturized thermal cyclers and innovative plastic tubes and plates. These products complement the recently launched Thermo Scientific Solaris qPCR gene expression assays and, together, deliver a more complete solution for customers. Combining the gene-specific MGB-based probes from Thermo Scientific with the advanced enzyme performance from Finnzymes will further enhance qPCR assay technology.

Finnzymes will be integrated primarily into Thermo Fisher Scientific’s Analytical Technologies Segment, with some equipment and consumables product lines being added to the laboratory products and services segment. The transaction is expected to close during the first quarter of 2010. The company does not expect this transaction to have a material impact on its 2010 financial results.

Oxford Nanopore Technologies Ltd. has raised £17.4 million ($28 million) in new funding. The round was funded by existing investors including Lansdowne Partners, IP Group, and Invesco Perpetual, new undisclosed U.S. institutions, and the company’s DNA sequencing marketing partner Illumina UK Ltd.  The company has previously raised £32 million since its formation in 2005.

The proceeds will be used for accelerated development of the company’s proprietary platform technology, which uses real-time electronic measurement of current through small holes (nanopores) to identify molecules of interest as they interact with the nanopore. In addition to the development of the core platform technology, funding will be directed to the company’s lead project in DNA sequencing and to start early work in protein analysis. Both projects utilize common elements of this modular platform.

“This new investment recognises our progress in 2009 and highlights the potential impact of our nanopore-based sensing platform. We are delighted to have strong support from our existing shareholders and this important vote of confidence from new ones,” said Dr. Gordon Sanghera, CEO of Oxford Nanopore. “The common elements of our technology platform are now developed enough to merit exploring new applications.  In addition to our lead programme in DNA sequencing we are now initiating a project in nanopore protein analysis.  This exploits the value of a platform technology; we are aiming to add substantial shareholder value with only incremental investment.”

Cepheid reported revenue for the fourth quarter of 2009 of $49.2 million. Net loss was $4.3 million, or $(0.07) per share, which compares to revenue of $37.8 million and a net loss of $6.0 million, or $(0.10) per share, in the fourth quarter of fiscal 2008. Excluding amortization of purchased intangible assets and stock compensation expenses, non-GAAP net income for the fourth quarter of fiscal 2009 was $0.3 million, or $0.01 per share. This compares to a non-GAAP net loss of $2.5 million, or $(0.04) per share, in the fourth quarter of fiscal 2008.

For the full fiscal year ended December 31, 2009, Cepheid reported revenue of $170.6 million. Net loss for the full year was $22.5 million, or $(0.39) per share, which compares to a net loss of $22.4 million, or $(0.39) per share in 2008. Excluding amortization of purchased intangible assets and stock compensation expenses, non-GAAP net loss for the full year was $5.0 million, or $(0.09) per share. This compares to a non-GAAP net loss of $7.1 million, or $(0.13) per share, for the full year 2008.

“Increasing recognition of the accuracy and ease of use of our GeneXpert System, coupled with one of the broadest menus of rapid molecular tests available on the market, resulted in year-over-year growth of 28% in our clinical business,” said John Bishop, Cepheid’s chief executive officer. “During 2010, we expect our clinical business will continue to grow rapidly, as we build on our leadership position in molecular diagnostic testing for healthcare associated infections and further extend our women’s health test menu and our menu for other critical infectious diseases.”

Carilion Labs has entered into an agreement to merge with Greensboro, North Carolina-based Spectrum Laboratory Network to form a major laboratory company offering comprehensive clinical, anatomic pathology and esoteric testing services.

The merger will create a new and stronger regional hospital laboratory company, serving 37 hospitals and 14,000 physicians in eight states, with more than 2,600 employees and annual revenues of more than $300 million.  Carilion Clinic will own 33% of the new company. Carilion’s president and CEO, Edward G. Murphy, MD, and two other Carilion appointees will sit on the board.  Novant Health, a minority owner in Carilion Labs, will remain an equity owner in the new company and will also hold a seat on the board. The company will be jointly headquartered in Roanoke, VA and Greensboro, NC.

The pending merger, which was facilitated by Carilion Labs’ financial advisor Lazard Middle Market LLC, follows the purchase of Spectrum by Welsh, Carlson, Anderson and Stowe (WCAS), a private equity firm with experience in the healthcare and laboratory industry.

“A new company that combines the strengths and shared values of Carilion and Spectrum with a focus on hospital laboratory services will significantly improve services to our customers and their patients, and provides a strong platform for further expansion within the region and across the nation,” said Murphy.

David Weavil, a 30-year veteran of the laboratory industry will serve as the new company’s chief executive officer.

“We are excited to be partnering with the Carilion Clinic and David Weavil, a long time lab industry executive.  We have a proven track record of partnering with not-for-profit health care systems to help them expand their delivery systems and reach within their medical community.  Carilion Labs and Spectrum Laboratories each have an excellent reputation with clinicians for providing excellent clinical and anatomic pathology services and we hope to continue to build on that reputation and bring the approach to other communities,” said WCAS general partner Sean M. Traynor.

Following regulatory approval, the merger is expected to close by the end of February, 2010.

Applied Biosystems LLC (part of Life Technologies Corp.) and Idaho Technology Inc. have signed a cross-licensing agreement that covers a broad range of products including hardware, software, and reagents. The agreement includes patents relating to real-time polymerase chain reaction methods and instrumentation, including the 5’ Nuclease process and the use of SYBR Green I in PCR reactions.

“This agreement demonstrates both companies’ commitments to advancing quality research in the applied and life science fields. It also enables innovation in a more open environment that is good for business and ultimately benefits customers.” says Randy Rasmussen, president of Idaho Technology Inc.

The intellectual property covered by this agreement has been instrumental in expanding applications in molecular biology and has been equally influential in each company’s success as a leading provider of innovative solutions for DNA analysis. The financial terms of the agreement will not be disclosed.

Phadia announced that FDA has cleared the ImmunoCAP Rapid Reader II, a part of the ImmunoCAP Rapid System, used to aid in the diagnosis of allergy in the physician’s office. This clearance now allows Phadia to begin marketing the ImmunoCAP Rapid System to physicians throughout the United States having laboratories that meet CLIA standards for moderately complex testing.  The test requires a simple capillary blood draw, and test results are available to the physician in 20 minutes.

With ImmunoCAP Rapid, physicians who treat asthma and rhinitis patients will have semi-quantitative measurements of IgE levels for ten common inhalant allergens in the United States. With this insight, clinicians can differentiate between atopic and non atopic etiologies contributing to their patient’s symptoms, counsel their patients for allergic trigger avoidance, develop targeted exposure reduction action plans specifically tailored to each patient’s allergic sensitization profile, and prescribe the right medications.

ImmunoCAP Rapid represents an important addition to the ImmunoCAP Specific IgE blood test.  ImmunoCAP Specific IgE was the first allergy test to be cleared by FDA as a truly quantitative test for identifying allergen sensitization. The European version of ImmunoCAP Rapid has been available in selected countries for more than three years.  Phadia US is preparing to market and sell ImmunoCAP Rapid to physician-operated laboratories that meet CLIA standards for moderately complex testing in the United States early this year.