Medical Device Link.

100^th Issue

To commemorate the 100^th issue of IVD Technology, the editors have compiled 100 news items from all of the past issues. This article recaps the important developments and major milestones in the IVD industry in various areas such as business, technology, legal, and regulatory. This article demonstrates how much the IVD industry has evolved during the past 12 years, and how much the industry has grown and become more complex. The news items in this article also show how innovative the industry is, and how much IVD manufacturers have been involved in developing cutting-edge technologies. For example, molecular diagnostics were unchartered territory that few manufacturers dared to enter; now, molecular diagnostics are a standard product offering in most companies.

In addition, the article shows how certain issues that IVD manufacturers have been grappling with remain the same, and how far the industry still needs to go. Medicare reimbursement and home-brew tests have always been and remain critical issues that have not been resolved yet and continue to be challenging.

This article provides only a very brief snapshot of these news items.

If any of these items grab your attention and you are interested in getting more information about them, they can be accessed via the IVD Technology Web site at www.ivdtechnology.com.

 

1995

January: Anonymous Test Services, Waldheim Pharmazeutika, and Viral Testing Systems formed a strategic alliance to expedite development of assay systems involving home sample collection for HIV testing. The companies will generate clinical study data, which will support the nonexclusive application of Waldheim confirmation products to home testing.

February Scientist prepares DNA samples for decoding with Superchip technology developed at Argonne National Laboratory.

February: Andrei Mirzabekov has been named to head the human genome research project at the Department of Energy’s Argonne National Laboratory. The project aims to develop a new superefficient biochip to decode the human genome. A number of biotechnology companies have expressed interest in the biochip.

March: NCCLS issued two guidance documents on performance of immunodiagnostic tests. “Specifications for Immunological Testing for Infectious Diseases” includes guidelines to improve predictive values in diagnosis of disease and enhance interlaboratory comparability and performance. “Assessing the Quality of Radioimmunoassay Systems” addresses receptors, radiolabeled analytes, separation reagents, and calibrators.

April: The market for enzymes will be completely transformed by 1998. New developments in enzyme manufacture, immobilization, and protein engineering will fuel growing demand for enzymes. Changes in technology and enzyme formats, particularly in the clinical diagnostics sector, are altering the sales of bulk enzymes for substrate analysis.

May: NASA has licensed an advanced cell culturing technology, the rotating wall bioreactor, from Synthecon. The device produces improved tissue cultures that promise a superior three-dimensional structure. NASA and the National Institutes of Health recently signed an agreement to collaborate on developing this technology.

June: A fingerprick test to determine the presence of H. pylori appears to be heading down the home stretch in terms of development. The test by ChemTrak will be distributed by Astra Merck, which has exclusive rights to sell it in the professional and over-the-counter markets.

July The contrast in antibody recovery between the traditional approach (left) and the microwave method (right).

July: BioGenex Laboratories has taken BioTek Solutions Inc. to court, asserting infringement of a patent that covers “a novel method of utilizing microwave energy to recover immunological information from tissue samples.” BioGenex’s complaint asserts BioTek’s marketing of instrumentation that allegedly used the microwave technique constitutes “acts of infringement.”

September: Clinical trials at two different Washington universities have focused on distinguishing between free prostate-specific antigen (PSA) and bound PSA in the bloodstream, rather than on a total PSA measure. The American Urologic Association declines to endorse any specific method, but it has begun supplying information describing the free-versus-bound approach.

November: Paracelsian Inc. wants to patent p34 as a cancer marker—a move that’s igniting interest in this low-profile protein. But, although p34 may help to expand and redefine the diagnosis of cancer, it’s not likely to replace the much studied old standby, p53, according to industry sources.

 

1996

January/February The market for point-of-care IVDs is completely different from the market for traditional analyzers.

January/February: Most point-of-care devices are coming from small, often single-product companies that skip nimbly between the feet of their slow-moving corporate-giant competitors. To stay on top of the food chain, some of those giants have been scooping up their smaller rivals through acquisitions and licensing agreements that benefit both.

March/April: Several companies say they are close to hatching a simple maternal blood test to determine the genetic health of an unborn baby. But experts warn that the problem of harvesting substantial quantities of fetal cells from the mother’s blood has yet to be solved.

May/June Color-enhanced electron photomicrograph of human papillomavirus type II.

May/June: An FDA-approved assay for a cervical cancer marker has arrived, allowing much more accurate diagnosis. The assay detects infection by certain types of human papillomavirus (HPV) that are associated with increased risk of cervical cancer. Developed by Digene Inc., the HPV DNA test has greater sensitivity for premalignant lesions.

July/August: Gains in diagnostic sensitivity for detecting abnormal levels of thyroid-stimulating hormone (TSH) are paving the way to quick, reliable assessment of thyroid function. The new third-generation TSH assays are so sensitive that they pick up subclinical biochemical changes, which precede any symptoms that would require treatment.

September/October: More than half a dozen companies are developing hepatitis C virus (HCV) tests, all based on a groundbreaking finding at Chiron Corp. Since the patent covers the virus’ RNA sequences and the use of recombinant proteins in HCV immunoassays, any test that uses them requires a Chiron licensing agreement.

November/December: FDA and CDC have undertaken a study to determine whether current IgM-based tests for Toxoplasma gondii are turning up too many mistaken results. The study is being opened in the wake of CDC findings that a high number of results from commercial toxoplasmosis assays were incorrect.

 

1997

January/February HIV-1 test manufacturers are expanding the sensitivity of test kits to include group O HIV-1.

January/February: Manufacturers of HIV-1 tests are working to expand the sensitivity of test kits to include group O HIV-1. Currently marketed assays to detect infection with HIV-1 are optimized for group M viruses. But their track record has been less than stellar for detecting viruses of group O.

March/April: Estimates put the diagnostic market for Alzheimer’s disease at $200 million. But if it were as easy as winner-take-all, Athena Neurosciences would be in the catbird seat. The company’s ADmark assays were the first on the scene and have received headline press coverage usually reserved for breakthrough drug treatments.

May/June Injection-molded plastic lab chips promise low cost and disposability.

May/June: Development of an economically feasible lab-on-a-chip is getting a boost from the efforts of two Northern California companies. The breakthrough is the work of competitors Soane Biosciences and Caliper Technologies Corp., now running neck and neck in the race to develop low-cost, disposable lab chips made with injection-molded plastic.

July/August: FDA has called for an investigation into the morbidity and mortality associated with home use of a new generation of glucose monitors. But the significance of the adverse events reported remains elusive, even to the scientist who chaired the advisory panel, Henry Nipper, PhD.

September: Consolidation in the IVD industry has hit a fevered pitch. Before year’s end, two megamergers will have taken place: Roche Holding with Boehringer Mannheim, and Dade International with the Behring Diagnostics unit of Hoechst Behring. Another merger is also in the works between multinational giant Becton Dickinson and PharMingen.

November/December: European furor over the outbreak of mad cow disease is threatening upheaval in the IVD industry. The EU ordered a ban on all products made from cattle parts that could carry bovine spongiform encephalopathy. The ban will affect blood coagulant, tetanus, and IVDs that use calves’ brains as media.

November/December: A wave of patent litigation has increased the importance of the ongoing wars over intellectual property in the IVD industry. Entrepreneurial companies found that the best protection against takeovers is a well-guarded idea. Industry leaders are discovering that if they don’t protect their patents, imitators will swamp the market.

 

1998

January/February: Biosensors that promise to measure blood glucose easily and painlessly are the holy grail of insulin-dependent diabetics. The worldwide market for glucose monitoring products exceeds $2 billion and is growing annually by double digits. Painless monitors promise to grab an enormous chunk of this market.

March/April: At the Ernest Orlando Lawrence Berkeley National Laboratory, Carolyn Bertozzi and her colleagues have succeeded in altering the surface properties of cells by growing them in media containing customized oligosaccharides. Bertozzi’s research uses the cell’s own biosynthetic machinery to incorporate unnatural functional groups onto the cell surface.

May/June: Although many researchers believe that nucleic acid amplification methods will eventually supplant culture, FDA wants to ensure that the new tests are an improvement and any discrepant results can be handled appropriately. FDA convened a meeting of four medical specialty panels related to clinical diagnostics to discuss these issues.

July/August The TD glucose monitoring system uses disposable patches to capture interstitial fluid.

July/August: While promising to be painless, many of the glucose monitors under development are not completely noninvasive. Using lasers or very small needles, they draw a sample of interstitial fluid to assay for glucose. But this approach is drawing challengers even before a representative product hits the market.

September Components of the virtual DNA sequencer recently patented by Visible Genetics.

September: Recent outbreaks of food-related gastrointestinal and renal disease have suggested a need for better methods and procedures for food testing. Several diagnostic manufacturers have taken up that challenge and are now applying state-of-the-art technology to improve the way food is inspected.

September: The U.S. Patent and Trademark Office recently granted a notice of allowance to Visible Genetics for its patent of a virtual DNA sequencer. The company’s new design combines the power of many sequencers into a large virtual instrument that can yield as many as 50,000 base pairs per hour.

November/December: For the tidy sum of $1.1 billion, Bayer Group is now the proud owner of Chiron’s IVD business. By acquiring Chiron Diagnostic Corp., Bayer Diagnostics will expand its product line and developmental pipeline to encompass technologies in molecular diagnostics, immunodiagnostics, and critical-care blood gas analyzers.

 

1999

January/February: The National Institute of Standards and Technology has announced the list of companies that will receive grants under its annual Advanced Technology Program (ATP) competition. The ATP is intended to further commercial applications of scientific research and provide financial aid to companies that are developing cutting-edge technologies.

March/April: The BTA stat test for recurrent bladder cancer has achieved a unique position as the first tumor marker test to receive FDA approval for home use. Manufactured by Bion Diagnostic Sciences and available by prescription, the BTA stat test allows recovering patients to monitor their risk for cancer recurrence.

May/June: Several large glucose monitor companies recently felt the sting of the French Medicines Agency (FMA) when their products were pulled off the market in France. FMA conducted its own performance tests and decided to suspend the marketing and distribution of 12 models of monitors.

July/August Cepheid’s Microfluidic Integrated DNA Analysis System can identify biowarfare agents in less than 30 minutes.

July/August: A new weapon in the battle against biowarfare and bioterrorism was recently delivered to the U.S. Department of Defense in the form of a rapid DNA analyzer by Cepheid Inc. According to the company, its Microfluidic Integrated DNA Analysis System can identify biowarfare agents in less than 30 minutes.

September ChromaVision Medical System’s Advanced Cellular Imaging System.

September: Automation of pathology testing in clinical laboratories is growing rapidly. With a number of new systems for automated reading and preparation of Pap-smear slides already approved by FDA, automated equipment for diagnosing other diseases or conditions is now in the works.

September: The IVD industry is developing single chips that can integrate numerous chemical manipulations. Some of the world’s largest electronics companies have taken notice and are forming alliances with diagnostic firms. For example, Clinical Micro Sensors and Motorola BioChip Systems entered into a multiyear strategic alliance.

November/December: The transition has been years in the making, but on January 31, 2000, FDA will begin making complexity categorization determinations under the 1988 Clinical Laboratory Improvement Amend-ments (CLIA). The Division of Clinical Laboratory Devices will take over this function from CDC, which has been performing the duty since 1992.

 

2000

January/February: Last November, FDA announced that Abbott Laboratories Inc. had signed a consent decree in which it agreed to pay a fine of $100 million—the largest ever by an FDA-regulated firm—because of its violations of the agency’s quality systems regulation.

March/April: If the recent spate of patent suits affecting IVD product development is any indicator, 2000 may become known as the year of intellectual property disputes. The patent wars affect not only cutting-edge research-laboratory technology but also rather common, low-tech equipment as well.

May/June The continuous glucose monitoring system by MiniMed Inc.

May/June: The development of a noninvasive blood analyte testing device has become a hot corporate race with potentially billions of dollars in revenues at stake. CME Telemetrix Inc. and Motorola announced a nonbinding letter of intent to form a strategic alliance to develop such a monitor.

July/August: To assist IVD manufacturers in meeting the IVD Directive’s traceability requirements for assay controls and calibrators, the National Institute of Standards and Technology has announced that it will sponsor a special workshop on measurement traceability for clinical laboratory testing and IVD test systems.

September Genometrix claims to have a new, faster technique for building DNA microarrays.

September: Genometrix claims to have a new technique for building DNA microarrays that is faster than techniques used by competitors. The technology is covered by the company’s latest patent (“Multiplexed Molecular Analysis Apparatus and Method”), which describes a capillary printing technique that produces one multielement array per second.

November/December: In an era when the Internet is making big news in different areas, it shouldn’t be surprising that IVD manufacturers are seizing on the tool for yet another innovative application. A group calling itself Lateral Flow Inc. launched a Web site devoted to promoting the use of lateral-flow technologies.

November/December: FDA’s Center for Devices and Radiological Health (CDRH) has recently named the members of a new medical advisory committee panel created for genetic diagnostics. The Molecular and Genetic Testing Panel will provide advice to CDRH on the appropriate scientific criteria to use in approving diagnostic tests for human genes.

 

2001

January/February The InstaCheck point-of-care drugs-of-abuse test by Forefront Diagnostics Inc.

January/February: Manufacturers of drugs-of-abuse tests for use at the point-of-care are preparing for a shakeup in the U.S. workplace testing market. Test services in this $450 million market are dominated by 66 laboratories. The largest of these laboratories are LabCorp, Quest Diagnostics, and LabOne Inc.

March: The pace for appointing notified bodies capable of certifying products under the terms of the IVD Directive has been slow. Some companies have begun to express concern over the lack of such appointments, and they wonder whether the majority of industry products will be able to meet the deadline.

April: FDA has issued a draft guidance on its proposed criteria for assigning waived-complexity status to IVDs under the terms of the 1988 Clinical Laboratory Improvement Amendments (CLIA). The draft document (“Guidance for CLIA Criteria for Waiver; Draft Guidance for Industry and FDA”) was formally released for public comment.

May: The market for bovine spongiform encephalopathy tests in Europe is growing tremendously, and seems likely to get even bigger over the next few years. The expansion in demand is due to a European Commission decree ordering that cattle more than 30 months of age be tested for the disease.

June: Legislation introduced in Congress is aimed at ensuring Medicare patients have access to the latest laboratory tests to detect and monitor disease. Proponents say that the “Medicare Patient Access to Preventive and Diagnostic Tests Act of 2001” would improve the current payment policy system for outpatient clinical laboratory tests.

July/August American Academy of Microbiology reported better IVDs must be developed to be prepared for bioterrorism.

July/August: New and better diagnostic tests must be developed in order for the United States to be best prepared for an act of bioterrorism. So says the American Academy of Microbiology in “Bioterrorism Threats to Our Future,” a report published this year.

September: Strong gains in the sales of rapid tests and patient self-testing products helped the European market to post increased revenues in 2000. Sales of laboratory testing products in Europe increased by 4.6% in 2000, nearly a full percentage point more than the growth reported for 1999.

September: Recent announcements by several companies suggest that molecular diagnostics may finally be ready to get its due as a legitimate business trend of the future. Notably, the news comes not from start-up companies, but from established industry players that have formed business units to focus entirely on molecular technologies.

November/December: If all goes according to industry’s wishes, a set of international standardized symbols for use on IVD product labels may be in place some time soon. However, getting FDA to sign off on the use of such symbols is proving to be a significant hurdle.

 

2002

January/February: The bioterrorism scare that has terrified the nation has caused a flurry of activity in the IVD industry. Such activity includes companies coming up with better and faster anthrax tests, and forming partnerships with government agencies to develop systems that could aid in combating bioterrorism.

March: The IVD industry has voiced approval of new policies regarding Medicare coverage for laboratory tests. The rule outlines new national Medicare coverage and administrative policies for 23 clinical laboratory tests. The tests included under the new rule make up about 60% of all Medicare laboratory claims.

April Components of an integrated microchemistry lab from Sandia National Laboratories fit into a pea pod.

April: The worldwide market for microarrays, microfluidics devices, and other biochips is expected to grow at an annual rate of 65% and reach $3.3 billion by 2004. Complete chemical labs-on-a-chip technologies will have the greatest impact on the medical diagnostics and laboratory instrumentation markets.

May: Developing countries offer the most promising growth in the world IVD market; and molecular diagnostics and point-of-care technologies will play pivotal roles in increasing the worldwide IVD technology revenues. In 2000, the world market revenues for diagnostics were $19.9 billion and are projected to reach $29.2 billion by 2007.

June: It’s not exactly the dot-com bonanza that device marketers expected several years ago. But IVD manufacturers are discovering that marketing by means of an interactive, informative Web site can help them to reap the benefits of having a more informed public.

July/August The Cholesterol 1,2,3 test is the first noninvasive cholesterol test approved by FDA.

July/August: In hopes that quick, convenient tests will eventually spur at-home use by consumers, International Medical Innovations Inc. is marketing a test that offer results in 3 minutes. The company recently received FDA clearance for its Cholesterol 1,2,3 test, the first noninvasive cholesterol test to go on the market.

September: Dade Behring Inc. has finalized and implemented a debt restructuring plan through a prepackaged Chapter 11 filing. The company reached a debt-to-equity swap agreement with its banks, bondholders, and owners that will eliminate about half of its debt and provide its creditors with equity in the company.

September: Bayer Diagnostics has acquired Visible Genetics Inc. (VGI), a deal with a total value of $61.4 million. Under the terms of the deal, Bayer will purchase VGI’s outstanding common shares at a cost of $1.50 per share and Series A preferred shares at par plus accrued dividends. November/December: FDA’s Center for Devices and Radiological Health (CDRH) will establish a new office-level organization, the Office for In Vitro Diagnostic Device Evaluation and Safety (OIVD). This office will implement structural and functional changes in regulating IVDs, and consolidate all premarket, compliance, and postmarket IVD regulatory activities into one unit.

 

2003

January/February The OraQuick Rapid HIV-1 Antibody test by OraSure Technologies was approved by FDA.

January/February: OraSure Technologies Inc. received FDA approval to manufacture and market its Ora-Quick Rapid HIV-1 Antibody Test, a point-of-care test designed to detect HIV antibodies in fingerstick whole blood samples within 20 minutes. This test had sensitivity of 99.6% and specificity of 100% in clinical studies performed with blood specimens.

March: Diagnostic laboratories are participating in a surveillance effort designed to alert the United States to a bioterrorism attack. Newly modified air monitors equipped with pathogen filters are scanning the air for bioterrorism agents. The monitoring system, dubbed Bio-Watch, relies upon the work of laboratories within the Laboratory Response Network.

April: Roche has licensed Affymetrix’s GeneChip DNA microarray technology. The agreement has given Roche nonexclusive access to Affymetrix’s array and instrument technologies for up to 18 years. This alliance will be used to develop and commercialize microarrays with diagnostic applications for a wide range of disease areas.

May: A global collaboration among a group of laboratories has succeeded in developing diagnostic tests that could help prevent the spread of severe acute respiratory syndrome (SARS). The World Health Organization established a collaborative multicenter research project devoted to finding and developing diagnostic tests for SARS.

June: Governments around the globe have expressed concern over direct-to-consumer (DTC) advertising of genetic tests and over home-use genetic tests. A report from the Human Genetics Commission (HGC) advocates stricter controls on DTC genetic testing and discourages predictive tests that rely on home testing or home sampling.

July/August: The menu of state-mandated newborn screening IVDs may soon increase as the result of a bill introduced in the U.S. Senate. The Newborn Screening Saves Lives Act of 2003 would provide improved resources for newborn screening initiatives by allowing more healthcare facilities to purchase tandem mass spectrometry technology.

September: Roche has acquired Igen International in a deal estimated to be worth about $1.4 billion. Through this deal, Roche will secure new nonexclusive, fully paid-up worldwide and perpetual rights to Igen’s electrochemiluminescence (ECL) technology. By securing the rights to this technology, Roche will continue to commercialize the ECL technology.

November/December U.S. Senate approved legislation providing protection against discrimination on the basis of one’s genetic information.

November/December: The U.S. Senate approved legislation that would provide protection against discrimination by employers and health insurers on the basis of an individual’s genetic information. Senate passage of the 2003 Genetic Information Nondiscrimination Act may well be viewed as ground gained along the path to public-wide adoption of genetic testing.

November/December: The U.S. government is providing funds for a new research program in which one of the long-term objectives is designing and developing diagnostic approaches for biodefense and emerging diseases. Totaling approximately $350 million, the grants will establish eight Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research.

 

 

 

2004

January/February: FDA has released a draft guidance on the use of symbols on labels for IVDs sold in the United States. In an effort to conserve space and increase clarity, FDA has officially recognized 25 symbols for use on IVD labels.

March: FDA issued a revised draft guidance on data and labeling requirements in premarket notification submissions for drugs of abuse screening tests. This new document supersedes and updates two previous guidances that were published in 2000. The draft guidance covers screening tests for amphetamines, cocaine, methamphetamines, opiates, marijuana, and phencyclidine.

April: The recent outbreaks of avian influenza in Asia have caused considerable concern and brought forth the need for continued vigilance in testing for the virus. U.S. government officials have realized this need and have been working on tests that are more effective in diagnosing avian flu.

May: The approval of a rapid HIV test for use with oral fluids may indicate more openness toward oral diagnostic tests by regulatory officials. With such greater acceptance, more IVD companies may jump into developing oral tests, which could lead to substantial growth in this market area.

June The Handheld Advanced Nucleic Acid Analyzer (HANAA) developed by Lawrence Livermore National Laboratory.

June: President Bush recently approved a directive that provides a framework for the nation’s biodefense program. While the directive does cover various medical and public health issues, it fails to recognize the critical role of diagnostics as a part of biodefense efforts.

July/August: The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) has been working on a pilot program that will enable IVD manufacturers to submit 510(k) applications online. This phase of the program (called the Turbo 510(k) project) will be fully implemented and made available by December 2004.

September: Continued strong gains in the sales of patient self-testing products and rapid tests helped the European IVD market to post growth in 2003. Sales of laboratory testing products in Europe grew by 5.6% in 2003, a slight decrease compared with the 5.9% growth rate reported for 2002.

November/December The GeneChip 3000Dx by Affymetrix received a CE mark for IVD applications.

November/December: Diagnostic Products Corp. received a subpoena from the U.S. Attorney General’s Office to produce to a federal grand jury documents relating to trading in the company’s securities and the exercise of options by employees, officers, and directors in early 2004.

November/December: Affymetrix Inc. launched in Europe its GeneChip System 3000Dx, the world’s first microarray instrument system for clinical diagnostics. In accordance with the IVD Directive, this system received a CE mark for IVD applications and can be used by clinical labs in Europe to analyze microarray diagnostics.

 

 

2005

January/February: Martin D. Madaus, PhD, has left Roche Diagnostics to become the new president and chief executive officer of Millipore Corp. Madaus will assume the role of Millipore’s president and CEO from Francis J. Lunger, who will remain as chairman of the board during a transition period.

March Four of the 25 symbols that FDA has approved for use on IVD labels for professional users.

March: Following a relatively quiet comment period, FDA has released its final guidance on the use of symbols for IVD labeling. The provisions in this document allow IVD manufacturers to choose from among 25 widely recognized symbols when labeling products for professional users.

April: President Bush’s federal budget for fiscal year 2006 does not make any specific proposals to cut reimbursement rates for clinical laboratory services. However, industry analysts believe that it is still too early to tell whether or not the government may impose such cuts later.

May: FDA issued a final guidance titled “Pharmacogenomic Data Submissions.” This guidance clarifies how the agency will evaluate pharmacogenomic data. It also describes what data will be needed during the marketing application review process, the format for submissions, and the data that will be used during regulatory decision making.

June FDA issued a preliminary concept paper on drug-diagnostic codevelopment.

June: FDA has issued a preliminary concept paper on drug-diagnostic codevelopment. FDA appears to be continuing to demonstrate its support for advances in personalized medicine. This concept paper reflects FDA’s preliminary thoughts on how to codevelop prospectively drugs and tests in a scientifically robust and efficient manner.

July/August: Attracted to better position itself as the personalized medicine market takes shape, Beckman Coulter Inc. has acquired Agencourt Bioscience for approximately $100 million. If the company achieves certain revenue and operating income targets, it could receive an additional $40 million in contingent payments through 2007.

September: Patients and physicians rely on IVDs for critical information to make healthcare decisions. However, significant access barriers discourage the use of new IVDs, according to a report prepared by the Lewin Group. The Lewin report concluded that Medicare payment policies for new diagnostics are “archaic, impractical, and severely flawed.”

November/December: CMS is moving forward with its planning of a demonstration project for competitive bidding of clinical laboratory services. While CMS is still working on the design and implementation of the demonstration, industry analysts believe that this competitive bidding project will have a detrimental effect on IVD manufacturers.

November/December: AdvaMed has submitted a revised list of ASR frequently asked questions to FDA. The proposal, which builds on AdvaMed’s existing ASR document, offers a more detailed definition of so-called home brews and explains how they differ from products labeled as research use only or investigational use only.

 

2006

January/February: The Bush administration’s plan to prepare for an avian influenza pandemic includes policies to “develop and deploy rapid diagnostics with greater sensitivity and reproducibility to allow on-site diagnosis of pandemic strains of influenza.” Government agencies and several IVD companies have initiated a number of efforts to address this issue.

March: Novartis AG received regulatory approval from the U.S. Federal Trade Commission for its acquisition of Chiron Corp. Novartis will acquire the remaining 113 million Chiron shares that it does not currently own for $45 per share in cash, or a total of approximately $5.1 billion.

April: Despite the numerous challenges for IVD manufacturers, the IVD market in China remains one of the world’s most promising emerging markets. The IVD market in China has more than doubled during the past 10 years, with the total market reaching over $700 million in 2004.

May: Serologicals Corp. has been actively involved in the acquisitions market lately. During a recent 10-day span, the company announced two separate acquisition agreements: Cytomyx Ltd. and Linco. According to Serologicals officials, these acquisitions will serve two very different purposes in the company’s overall strategic growth plans.

June: Siemens Medical Solutions and Diagnostic Products Corp. (DPC) have entered into a merger agreement under which Siemens will acquire DPC for approximately $1.86 billion. According to the agreement, each DPC shareholder will receive $58.50 per share of DPC stock, and DPC will become a wholly owned subsidiary of Siemens.

July/August: A bill introduced in Congress is designed to reform Medicare reimbursement policies. The 2006 Advanced Laboratory Diagnostics Act proposes improving current processes for obtaining adequate reimbursement for new clinical diagnostic lab tests and affording timely correction of historic payment errors that often lead to inadequate payment.

September Siemens signed an agreement to acquire Bayer Diagnostics for approximately $5.4 billion.

September: Siemens signed an agreement to acquire Bayer Diagnostics for approximately $5.4 billion. The acquisition is expected to close sometime during the first half of 2007. Siemens officials said one of the objectives in acquiring Bayer is that it will enable Siemens to expand its position in molecular diagnostics.

November/December Senator Barack Obama (D–IL) introduced the 2006 Genomics and Personalized Medicine Act.

November/December: Senator Barack Obama (D–IL) introduced the 2006 Genomics and Personalized Medicine Act. The bill proposes to increase funding for research on genomics, expand the genomics workforce, and provide a tax credit for the development of diagnostic tests that can improve the safety or effectiveness of drugs.

November/December: Responding to growing concerns about the lack of oversight of such direct-to-consumer (DTC) genetic tests, Senator Gordon Smith (D-OR), chairman of the Senate Special Committee on Aging, called for a year-long investigation by the Government Accountability Office into companies that are selling such tests.

 

2007

January/February CMS decided not to publish a draft proposed rule on creating a genetic testing subspecialty.

January/February: CMS decided not to publish a draft proposed rule on creating a genetic testing subspecialty. Among the reasons given for this decision included concerns raised by the Department of Health and Human Services, such as ethical, social, and legal issues related to the Clinical Laboratory Improvement Amendments (CLIA).

March GE acquired the primary IVD businesses of Abbott Laboratories and Abbott Point-of-Care for $8.13 billion.

March: General Electric (GE) agreed to acquire the primary IVD businesses of Abbott Laboratories and Abbott Point-of-Care for $8.13 billion in cash. These divisions generated estimated revenues of $2.5 billion in 2006. Through this acquisition, GE would broaden its $16 billion healthcare business and become a full-fledged IVD company.

April: The Bush administration released its fiscal year 2008 budget outlining its spending priorities for the next year. The President’s budget includes a proposal to adopt competitive bidding for laboratory services nationwide without waiting for the completion of the congressionally mandated demonstration project.