IVD Technology Blog » 2009

Archive for September, 2009

SeraCare Receives CDC, NIH Contracts

Wednesday, September 30th, 2009

SeraCare Life Sciences Inc. announced that it has been awarded two new contracts from CDC and NIH, and that a third existing contract has been expanded by NIH to support federally-funded HIV research and testing. These contracts represent a combined $10.8 million in new funding if all options are exercised over the life of the contracts.

Under a new contract awarded by CDC as part of the CDC’s HIV-1 Rapid Test Proficiency Program, SeraCare will support efforts to ensure that laboratories performing HIV-1 assays are achieving accurate results. The company will provide well characterized HIV-1 positive and negative plasma, and will test, dispense, and distribute panels to approximately 650 laboratories participating in this performance evaluation program, which is used as a self-assessment tool for facilities performing HIV-1 rapid testing. The five-year contract is valued at over $3.6 million if all options are exercised by CDC.

Under a second new contract awarded by PPD Inc. to support NIH’s Division for HIV Clinical Research Support Services, SeraCare will collect, characterize, assemble, and distribute a comprehensive panel of current worldwide HIV strains. These efforts are designed to establish a standardized set of viral reagents to help monitor and update blood screening and diagnostic assays, activities that play a critical role in ensuring that the world’s blood supply is safe, and to assist in the development of vaccines for HIV. The 15 month contract is valued at $2 million.

Under an expanded, existing contract with NIH to support the National Heart, Lung, and Blood Institute Biologic Specimen Repository, SeraCare will support the growth of the repository and quality control the historic AIDS and AIDS-related studies in the collection in preparation for anticipated broader use. The $5.2 million expansion increases the remaining value of the contract over the next two years to $6.3 million.

Tags: Grants, Infectious Diseases
Posted in Business News, Government Affairs | No Comments »

Sequenom Fires Execs Due to Mishandled Test Data

Tuesday, September 29th, 2009

Sequenom Inc. announced the completion of the independent investigation by a special committee of independent directors related to the test data and results for the company’s noninvasive prenatal test for Down syndrome. The independent counsel engaged by the special committee interviewed over 40 witnesses and reviewed over 300,000 documents and emails.

Based on the special committee’s work and recommendations, the independent members of the company’s board of directors have concluded that as a result of the company’s attempted transition from researching potential molecular diagnostic tests to developing and commercializing those tests, the company failed to put in place adequate protocols and controls for the conduct of studies in the Down syndrome program at the company. Certain of the company’s employees also failed to provide adequate supervision. In the absence of such protocols, controls, and supervision, the test data and results in the company’s Down syndrome program included inadequately substantiated claims, inconsistencies, and errors. Due to deficiencies in the company’s disclosure controls and procedures, in a number of instances, such test data and results were reported to the public in the company’s press releases and other public statements.

The company has terminated the employment of its president and chief executive officer, Harry Stylli, PhD, and its senior vice president of research and development, Elizabeth Dragon, PhD, effective immediately. In connection with the termination of Stylli’s employment, the company’s board of directors has requested that he resign as a director, which he is obligated to do under the terms of his employment agreement. The company has obtained the resignation of its chief financial officer, Paul Hawran, and one other officer. The company also terminated the employment of three other employees. While each of these officers and employees has denied wrongdoing, the special committee’s investigation has raised serious concerns, resulting in a loss of confidence by the independent members of the company’s board of directors in the personnel involved.

Effective today, the company’s board of directors has appointed chairman of the board Harry F. Hixson, Jr., PhD, and director Ronald M. Lindsay, PhD, to serve on an interim basis as chief executive officer and senior vice president of research and development, respectively. The company’s board of directors has also designated controller Justin J. File as principal financial and accounting officer.

Tags: Personnel, Research Results
Posted in Business News | No Comments »

Biomagnetics Diagnostics Lands $1M Funding

Monday, September 28th, 2009

Biomagnetics Diagnostics Corp., a producer of diagnostic systems and technology for malaria, tuberculosis, HIV and hepatitis testing announced it has received a equity-based financing commitment up to $1 million from investors and an anonymous philanthropic source. These funds will be used to further develop the company’s handheld testing platform targeting the areas of malaria and bovine tuberculosis testing.

“We are very excited to be receiving this equity investment as it shows the significant commitment of our investors to furthering our corporate goals,” commented Clayton Hardman, CEO of Biomagnetics Diagnostics. “Our first goal is to finalize our government laboratory partnership, which we believe will be occurring over the coming weeks. We will then use these new funds to quickly move this technology into the field where we believe a significant market exists. We have already landed our first commitment from China’s third largest dairy and we believe many other organizations are eagerly awaiting our market entry.”

Tags: Emerging Markets, Finance, Infectious Diseases, Point-of-care
Posted in Business News | No Comments »

Qiagen Acquires DxS

Wednesday, September 23rd, 2009

Qiagen has acquired DxS Ltd., a privately-held developer and manufacturer of companion diagnostic products headquartered in Manchester, United Kingdom. The transaction is valued at approximately $95 million in cash, subject to customary purchase price adjustments, plus up to an additional $35 million if specified commercial and other milestones are met.

With this acquisition, Qiagen has taken a strong leadership position in the new era of personalized healthcare. The company believes it offers all the required elements to help drive and shape this rapidly emerging trend in healthcare.

In addition, Qiagen unveiled for the first time that the combined company is currently active in over 15 collaborations with pharmaceutical companies to market and/or develop companion diagnostic products. The programs span genetic, expression, epigenetic, and other markers. Qiagen believes that this pipeline is the deepest such portfolio in the pivotal field of molecular diagnostics for personalized healthcare.

The acquisition of DxS brings to Qiagen a portfolio of molecular diagnostic assays and intellectual property, as well as a deep pipeline of active or planned companion diagnostic partnerships in oncology with many of the leading pharmaceutical companies, including seven of the largest drug makers in this field. These assets complement Qiagen’s existing strong portfolio of personalized healthcare diagnostic solutions and are very synergistic with Qiagen’s sample and assay technologies.

Under the terms of the agreement, Qiagen acquired the entire outstanding share capital in DxS. Qiagen expects to incur one-time charges of approximately $ 0.02 in EPS in the third quarter 2009 in connection with this acquisition. These charges primarily relate to consulting and advisory fees incurred in connection with the acquisition and the write-off of certain assets. In addition, based on preliminary analyses and following the streamlining of the portfolio, Qiagen expects this transaction to contribute approximately $6 million in sales in the remainder of 2009 and approximately $30 million in sales in 2010. On an adjusted basis excluding one-time charges, integration and restructuring costs, and amortization of acquisition related intangible assets, the acquisition is expected to be neutral to EPS in the remainder of 2009 and to be dilutive by $ 0.02 in 2010. Beyond 2010, it is expected that the acquisition will be accretive to adjusted EPS.

Tags: Merger & Acquisition
Posted in Business News, Personalized Medicine | No Comments »

Celera, Medco Collaborate on Testing for Compliance with Statin Therapy

Tuesday, September 22nd, 2009

Celera Corp. and Medco Health Solutions Inc. entered into a research collaboration to evaluate whether testing for a gene variant called KIF6 increases patient adherence with statin therapy. As part of this collaboration, the companies will conduct a prospective, randomized, open-label, multi-center study (AKROBATS – Additional KIF6 Risk Offers Better Adherence to Statins) to address the primary question of whether patient adherence with newly prescribed statin therapy is higher in those patients tested for KIF6 status than in those who are not offered the test. Medco expects to test approximately 650 members for their KIF6 status and compare adherence with statin therapy to an equally-sized control group whose KIF6 status is not known. Samples will be collected by using a simple cheek swab. Testing will be performed by Berkeley HeartLab Inc., a Celera subsidiary, using its laboratory developed test. Following review and approval by an Institutional Review Board, the study is expected to begin this fall, and patients’ statin adherence is expected to be monitored by Medco’s current pharmacy benefit methods over the course of 18 months.

All patients included in the study will be under the care of a physician who has already prescribed them a statin. The primary endpoint of this study is change in adherence to statin therapy in patients tested for KIF6 status compared to statin-treated patients who do not undergo KIF6 testing.

Tags: Collaboration
Posted in Business News, Personalized Medicine | No Comments »

Senate Finance Committee Proposes Tax on IVDs

Wednesday, September 16th, 2009

Senator Max Baucus, the chairman of the Senate Finance Committee, released a draft bill, “America’s Healthy Future Act of 2009.” This bill “would impose a fee on any person that manufactures or imports medical devices offered for sale in the United States. The aggregate fee on the sector would be $4 billion payable annually beginning in 2010. Under the Mark, the aggregate fee would be apportioned among the covered entities each year based on each entity‘s relative market share of covered domestic sales for the prior year. The Mark would require that the fee be paid on an annual basis.” To access the bill, click here. (The section on the proposed tax on IVDs is on page 215.)

AdvaMed (Washington, DC) released a statement expressing its opposition to the tax: “The proposed tax on the medical device industry is particularly onerous. Such a tax will sharply cut the resources available for research and development of life-saving medical treatments. For context, consider that the majority of device companies combined spent a total of about $9.6 billion on research and development in 2007. This new tax is nearly half that amount. The tax also exceeds the total amount of venture capital dollars invested in device companies in 2007 ($3.7B) and on an annual basis, is four times what device companies raised in 2007 for IPOs ($1B). Our industry must vigorously oppose the proposed tax on medical devices and diagnostics.”

To find information about contacting Senator Baucus, click here.

Tags: Legislation
Posted in Government Affairs | No Comments »

AdvaMed Voices Opposition to IVD Tax

Tuesday, September 15th, 2009

AdvaMed (Washington, DC) joined the battle by sending a letter to Senators Max Baucas and Charles Grassley “to express our opposition to the proposed tax on medical device and diagnostics products currently being considered by the Senate Finance Committee as part of broader health reform legislation. The proposed medical products tax will ultimately have a negative effect on patients, health care providers, and consumers, as it increases the cost of health care. We ask you to eliminate this proposal from consideration.” To access the entire letter, click here.

Tags: Legislation
Posted in Government Affairs | No Comments »

MassMEDIC Opposes Tax on IVDs

Monday, September 14th, 2009

The Massachusettes Medical Device Industry Council sent a letter to Senator John Kerry (D-MA) “to express strong oppostion to a proposed tax on medical device and diagnostics products currently being considered by the Senate Finance Committee as part of broader health reform legislation. The proposed tax would have a significant and unfair impact on our companies, our employees in Massachusetts, and the research and development we conduct in the state. We urgently ask for your assistance in eliminating this proposal from consideration.” To access the entire letter, click here.

Tags: Legislation
Posted in Government Affairs | No Comments »

Quidel Expects Record Results Due to Flu Tests

Friday, September 11th, 2009

Quidel Corp.announced that it currently anticipates its highest quarterly revenue and operating income in its history, driven by global shipments of its QuickVue Influenza A+B tests in the third quarter of 2009. Demand for its market-leading tests accelerated during the third quarter, consistent with reports of escalating influenza-like illness in the United States. Since the end of April 2009, the company has continued to manufacture flu tests seven days a week at its facility in San Diego and has the capacity to produce millions of additional tests per month to accommodate customer orders.

Quidel attributes the early demand for its rapid flu tests to a number of factors, as widely reported across the country:

CDC’s Week 34 Influenza Surveillance Report (for August 23-29, 2009) documented elevated levels of influenza-like illness in several Southeastern states, with all jurisdictions reporting regional or widespread flu activity.
The American College Health Association (ACHA) reported that 54% of the 189 colleges and universities that are tracking influenza say they have students with the flu. Schools and universities across the country are seeing spikes in the number of students with influenza-like illness as classes begin and students return to dormitories. Washington State University, with approximately 19,000 students, announced it is experiencing the nation’s largest flu outbreak, with 2,000 students impacted just before classes started. The ACHA reported several universities in Georgia combined had the second-highest attack rate or spread of flu-like illness.
According to the CDC’s Week 34 Influenza Report, the percentage of specimens testing positive for influenza by collaborating laboratories remained unusually higher during the week than is typically seen at this time of year. This may be due to a combination of factors including higher than normal circulation of influenza in the summer with the emergence of the 2009 H1N1 virus, changes in testing practices by healthcare providers, triaging of specimens by public health laboratories, and an increase in the number of specimens collected from outbreaks.

Tags: Financial Results, Infectious Diseases
Posted in Business News | No Comments »

IVD-Related News from CDC, OIVD, CMS

Thursday, September 10th, 2009

Several federal government agencies have recently made some announcements that are related to and could have an impact on the IVD industry:

1) CDC awarded a total of $22 million to 26 states and tribal organizations to provide colorectal cancer screening services for low–income people aged 50–64 years, who are underinsured or uninsured. The awards range from $358,283 to $1.1 million. The awardees are expected to begin screening patients for colorectal cancer within six months.

The states receiving five–year awards are: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Iowa, Maine, Maryland, Massachusetts, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, New York, Oregon, Pennsylvania, South Dakota, Utah, and Washington. The tribal organizations receiving awards are: Alaska Native Tribal Health Consortium, Arctic Slope Native Association, South Puget Intertribal Planning Agency, and Southcentral Foundation.

The funding will support screening and diagnostic follow–up care, data collection and tracking, public education and outreach, provider education, and an evaluation to measure the clinical outcomes, costs, and effectiveness of the program. The awardees can choose from among any of the recommended screenings for colorectal cancer – colonoscopy, sigmoidoscopy, and stool testing.

2) FDA issued a draft guidance for industry and FDA staff covering how IVDs for human papillomaviruses should be measured and handled for analytical and clinical performance. To access the draft guidance, click here.

3) The Department of Health and Human Services announced a new proposal that would cover HIV infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries of any age who voluntarily request the service. To access the proposed decision memo, click here.

Tags: CMS, FDA
Posted in Government Affairs, Regulatory Affairs | No Comments »