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Diagnostics & Imaging Week articles from July 2005

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Diagnostics & Imaging Week archives from July 2005

Task force recommends HIV test for all pregnant women.
July 7, 2005... A task force of the Agency for Healthcare Research and Quality (AHRQ; Rockville, Maryland) has issued a new recommendation suggesting that all pregnant women--not just those identified as at risk for contracting HIV--be screened for the...

BSX acquires Biophan stake; Immunicon raises $19.7 million.(Boston Scientific Corp.)
July 7, 2005... Biophan Technologies (West Henrietta, New York), a developer of next-generation technology in the MRI sector, reported reaching a definitive agreement with Boston Scientific (BSX; Natick, Massachusetts) for an equity investment and technology...

New study highlights link between X-ray and cancer.
July 7, 2005... WASHINGTON -- Low doses of radiation such as X-rays can lead to cancer, according to a new report from the National Academy of Science (Washington). Though the news may come as no surprise, there is a "preponderance of evidence" that shows...

Diagnostics & Imaging book eyes growth opportunities.(Brief Article)(Book Review)
July 7, 2005... Production on the BBI group's latest sourcebook, Advances in Diagnostics & Imaging: Emerging Markets for the 21st Century, has been completed and the 310-page volume is now available. "This is an intriguing area of medical technology," said...

CDRH annual report for FY04 shows dropoff in submissions.(Center for Devices and Radiological Health)
July 7, 2005... WASHINGTON -- Has the FDA medical device user fee program put a damper on the number of product submissions? Whatever the answer, in FY04 the number of device submissions received and reviewed by the agency has fallen off slightly since...

Smiths Medical awarded new contract from Premier GPO.(Grants/contracts)
July 7, 2005... Smiths Medical MD (St. Paul, Minnesota) has been awarded a three-year contract by Premier Purchasing Partners (San Diego) to offer the new Smiths Medical Piccolo Ultrasound System to its nearly 1,500 hospital and healthcare system members in...

Biofield, Bay Point Group in accord on merger/acquisition.(Deals roundup)
July 7, 2005... Biofield (Alpharetta, Georgia), developer of the Biofield Breast Proliferation Detection System (BDS), a noninvasive, radiation-free testing system, said it has agreed to a potential merger or acquisition with Bay Point Group (BPG; Miami),...

Inverness finds errors, restates several of its financial reports.(Brief Article)
July 7, 2005... Inverness Medical Innovations (Waltham, Massachusetts), a manufacturer of rapid diagnostic products, reported finding that its financial statements for FY04, and for the second, third and fourth quarters of 2004 and first quarter of 2005,...

Dr. Curtis Ponton will assume the role of vice president and chief scientist for the NeuroScan business group of sleep diagnostics firm Compumedics (El Paso, Texas).(People in Places)(Brief Article)
July 7, 2005... Dr. Curtis Ponton will assume the role of vice president and chief scientist for the NeuroScan business group of sleep diagnostics firm Compumedics (El Paso, Texas). Prior to joining Compumedics as a senior scientist in 2000,Ponton was a...

PBI Technology.(Mario Ehlers took the lead as PBI Technology's president, chief operating officer)(Brief Article)
July 7, 2005... PBI Technology (Seattle), a wholly owned subsidiary of Pacific Biometrics (PBME),has formed a new leadership team. Dr. Mario Ehlers, chief medical officer of PBME, took the lead as PBI Technology's president, chief operating officer and a...

Robb Young, product manager for the cardiac computed tomography (CT) business unit of Toshiba America Medical Systems (TAMS; Tustin, California), has been promoted to the newly created position of senior manager, market segment cardiology CT.(People in Places)(Brief Article)
July 7, 2005... Robb Young, product manager for the cardiac computed tomography (CT)business unit of Toshiba America Medical Systems (TAMS; Tustin, California), has been promoted to the newly created position of senior manager, market segment cardiology CT....

VirtualScopics.(appointment of Robert Klimasewski )(Brief Article)
July 7, 2005... VirtualScopics (Rochester, New York),a provider of advanced medical image analysis services, reported the resignation of Stuart Shapiro as CEO of the company and the appointment of Robert Klimasewski to fill that post on an interim basis until...

Biosite.(Product Briefs)(Brief Article)
July 7, 2005... Biosite (San Diego) said it is developing a second-generation Triage Cardio ProfilER Panel that will include myeloperoxidase (MPO), a marker of inflammation in the walls of coronary arteries. The company said it believes the addition of MPO can...

Power3 Medical Products.(early detection of breast cancer)(Brief Article)
July 7, 2005... Power3 Medical Products (The Woodlands, Texas), a proteomics company, reported that to date, it has enrolled 137 participants from three participating locations--the Clinical Research Center of Houston, Obstetrical and Gynecological Associates...

Adlyfe developing tests for 'mad cow,' blood screening.
July 14, 2005... While controversy continues to surround how U.S. authorities are responding to a Texas cow found to have "mad cow" disease in June, Adlyfe (Rockville, Maryland) is continuing on a course begun in 2003 to develop tests for testing cattle, blood...

GE Healthcare, Roche combine on Alzheimer's care project.(International report)
July 14, 2005... Roche (Basel, Switzerland) and GE Healthcare (Chalfont St. Giles, UK) have joined in a drug-and-imaging agent collaboration focused on developing personalized care for patients with Alzheimer's disease. Financial terms were not disclosed. ...

Philips to acquire Stentor; Tyco buying Vivant for $66m.
July 14, 2005... Royal Philips Electronics (Best, the Netherlands) reported that it would acquire Stentor (Brisbane, California), a provider of picture archiving and communication systems (PACs), for about $280 million in cash. Philips said that with the...

Three gatherings emphasize growing interest in med-tech.(Report from Israel)
July 14, 2005... ZICHRON YAAKOV, Israel -- A whirlwind of activity, including three major conferences, has highlighted the expanded foreign interest in the Israeli medical technology sector. For the first time, the organizing committee of Bio-Tech Israel...

Women delaying care as costs increase, Kaiser study reports.(Washington roundup)
July 14, 2005... WASHINGTON -- A new survey looking at access to health by women finds that a substantial percentage of women cannot afford to go to the doctor or have their prescriptions filled. According to the report, "Women and Healthcare: A National...

Diagnostic products, thermo in clinical chemistry accord.(Grants/contracts)
July 14, 2005... Diagnostic Products (Los Angeles) and Thermo Electron (Waltham, Massachusetts) reported that they have entered into an agreement for the co-development of a new, high-throughput clinical chemistry platform. That platform will integrate with...

The National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH; both Bethesda, Maryland), said it would provide nearly $18 million for 11 High-End Instrumentation (HEI) grants that will fund the purchase of equipment designed to advance biomedical research.(Grants/contracts)
July 14, 2005... The National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH; both Bethesda, Maryland), said it would provide nearly $18 million for 11 High-End Instrumentation (HEI) grants that will fund the...

Novadaq Technologies (Toronto) and the CarboMedics unit of the Sorin Group (Milan, Italy).(Grants/contracts)(Brief Article)
July 14, 2005... Novadaq Technologies (Toronto) and the CarboMedics unit of the Sorin Group (Milan, Italy), which focuses on medical technologies for cardiac surgery, said they have signed a North American agreement to distribute the SPY Intra-operative Imaging...

Biophan reports additional details of BSX agreement.(Financings roundup)
July 14, 2005... Biophan Technologies (West Henrietta, New York) has reported in an SEC Form 8-K/A filing further details of its technology licensing and equity agreements with Boston Scientific (Natick, Massachusetts), initially reported earlier this month....

Biophan expands intellectual property.(Briefly Noted)(Brief Article)
July 14, 2005... Biophan Technologies (West Henrietta, New York), a developer of next-generation medical technology, reported further expansion of its intellectual property portfolio in recent weeks with 13 new applications filed--resulting in 10% growth--to a...

Texas legislation allows for care of diabetic students.(Briefly Noted)(Brief Article)
July 14, 2005... The American Diabetes Association (ADA; Alexandria, Virginia) applauded the signing of the "Diabetes School Care Act," legislation in the state of Texas that is designed to help ensure that public schools in the state are responsive to the...

Bio-Nano Sensium, Nanotech in beta test program.(Briefly Noted)(Brief Article)
July 14, 2005... Bio-Nano Sensium Technologies (Abingdon, UK), a subsidiary of Advance Nanotech (New York), reported a limited beta test program of its wireless biosensor system. Beta-stage versions of Bio-Nano Sensium (BNS) system will be available to...

Tm Bioscience (Toronto), which focuses on the commercial genetic testing market.(Grants/contracts)(Brief Article)
July 14, 2005... Tm Bioscience (Toronto), which focuses on the commercial genetic testing market, said it has signed a five-year agreement to supply custom Tag-It reagents to InterGenetics (Oklahoma City) for OncoVue. According to InterGenetics, Oncovue has...

Anika Therapeutics.(Kevin Quinlan has been named CFO)(Brief Article)
July 14, 2005... Kevin Quinlan has been named CFO of Anika Therapeutics (Woburn, Massachusetts). Quinlan joins the company from Boston Biomedica, where he most recently served as president of its BBI Diagnostics division. Anika Therapeutics develops hyaluronic...

Combi-Matrix Molecular Diagnostics.(appointments)(Brief Article)
July 14, 2005... Cancer-based molecular diagnostics firm Combi-Matrix Molecular Diagnostics (CMD; Irvine, California), a wholly-owned subsidiary of CombiMatrix, an Acacia Research company, appointed Matthew Moore, PhD, director of research and development;...

E-Z-EM.(Tom McLaughlin has been promoted to the position of vice president-North America )(Brief Article)
July 14, 2005... Tom McLaughlin has been promoted to the position of vice president-North America imaging sales, for E-Z-EM (Lake Success, New York). McLaughlin has served the company in a series of positions since 1989, beginning as a territory sales manager...

Fischer Imaging.(Steven Durnil has been named president and CEO )(Brief Article)
July 14, 2005... Steven Durnil has been named president and CEO of Fischer Imaging (Denver), succeeding Harris Ravine, who resigned from the company as an officer and member of the board of directors effective immediately. Ravine will continue to serve in a...

InSight Health Services Holdings.(Bret Jorgensen has been appointed president and CEO )(Brief Article)
July 14, 2005... Bret Jorgensen has been appointed president and CEO of InSight Health Services Holdings (Lake Forest, California). He also will be elected to the company's board of directors. Michael Cannizzaro, president and CEO of InSight since August 2004,...

Medicsight plc.(Jonah Aburrow-Jones has been named to the newly created position of product and accounts manager )(Brief Article)
July 14, 2005... Jonah Aburrow-Jones has been named to the newly created position of product and accounts manager for Medicsight plc (London). He has more than 12 years of product management and sales experience, most recently serving as senior product line...

PBI Technology.(appointments)(Brief Article)
July 14, 2005... PBI Technology (Seattle), a wholly owned subsidiary of Pacific Biometrics (PBME), has formed a new leadership team. Dr. Mario Ehlers, chief medical officer of PBME, took the lead as PBI Technology's president, chief operating officer and a...

Toshiba America Medical Systems.(Mark Mindell has been appointed vice president)(Brief Article)
July 14, 2005... Mark Mindell has been appointed vice president, human resources, at Toshiba America Medical Systems (Tustin, California). He previously held similar posts with Philips Medical Systems, Invensys and Entex/ Siemens Business Systems. Toshiba...

Agilent Technologies.(Product Briefs)(Brief Article)
July 14, 2005... Agilent Technologies (Palo Alto, California) has introduced what it calls "the industry's most up-to-date microarray" to provide genome-wide coverage of the zebrafish (Danio rerio), and the first commercial whole mouse genome microarray based...

CAS Medical Systems.(Product Briefs)(Brief Article)
July 14, 2005... CAS Medical Systems (Branford, Connecticut) reported acceptance of an abstract demonstrating initial validation of its cerebral oximeter for presentation at the American Society of Anesthesiologists' (ASA) annual meeting in October. The...

Envisioneering Medical Technologies.(TargetScan, a new FDA-approved targeted prostate biopsy and cancer treatment system)(Brief Article)
July 14, 2005... Envisioneering Medical Technologies (St. Louis), a manufacturer of diagnostic and treatment technology, said a recent study confirms that TargetScan, a new FDA-approved targeted prostate biopsy and cancer treatment system, delivers improved...

Instrumentation Laboratory.(Product Briefs)
July 14, 2005... Instrumentation Laboratory (Lexington, Massachusetts), a manufacturer of in vitro diagnostic instruments, related reagents and controls, reported that it has received FDA 510(k) clearance for its HemosIL D-Dimer HS assay. This new-generation...

Meridian Bioscience (Cincinnati) reported that Viral Antigens (VIA; Memphis, Tennessee), its wholly owned subsidiary and supplier of purified virus proteins, received a patent titled "Specificity in the detection of anti-rubella IgM antibodies" from the U.S. Patent and Trademark Office.(Product Briefs)(Brief Article)
July 14, 2005... Meridian Bioscience (Cincinnati) reported that Viral Antigens (VIA; Memphis, Tennessee), its wholly owned subsidiary and supplier of purified virus proteins, received a patent titled "Specificity in the detection of anti-rubella IgM antibodies"...

Roche Diagnostics.(Elecsys PreciControl Tumor Marker control solution)(Brief Article)
July 14, 2005... Roche Diagnostics (Indianapolis) reported that it has received FDA clearance for its Elecsys PreciControl Tumor Marker control solution. The tumor marker provides laboratory professionals with the same control for six different tumor marker...

'Acting' no longer, Crawford is confirmed as chief of FDA.(Lester Crawford)
July 21, 2005... WASHINGTON -- After months of political wrangling, the Senate voted late Monday to confirm Lester Crawford as FDA commissioner. The confirmation passed handily with a vote of 78-16. The 67-year-old Crawford, who has served as acting...

Study says malpractice awards not source of rising health costs.
July 21, 2005... Not surprisingly, a new study shows that people in the U.S. spend much more on healthcare than in other countries--in 2002, 53% more, or $5,265 per capita. But what may come as a surprise is that the study authors do not attribute this to...

FDA panel rejects Alzheimer's test data from Nymox--again.(Panel Discussion)
July 21, 2005... GAITHERSBURG, Maryland -- In a vote of 5-2, an FDA panel on Friday recommended against approval of a test kit from Nymox Pharmaceutical (Maywood, New Jersey), offered by the company as an aid in the diagnosis of Alzheimer's disease (AD). ...

Genomic Health sets $75m IPO: Solexa gathers in $24 million.
July 21, 2005... Genomic Health (GHI; Redwood City, California), a developer of diagnostic tests for cancer, has filed to raise as much as $75 million in an initial public offering (IPO), but did not specify the number of shares to be sold or the targeted share...

AdvaMed designates med-tech veteran Ubl as new president.(Advanced Medical Technology Association appoints Steven Ubl as new president)
July 21, 2005... WASHINGTON -- Rudderless for nearly three-and-a-half months, the Advanced Medical Technology Association (AdvaMed; Washington) tapped Steven Ubl to steer the association as its new president. Ubl is no stranger to the medical device...

Xenomics expanding R&D via joint-venture accord in Italy.(International report)
July 21, 2005... Xenomics (New York), a developer of DNA testing systems, reported that it has finalized an R&D agreement with the Lazzaro Spallanzani Institute (Rome), Italy's National Institute for Infectious Diseases. Previously, Xenomics and...

Calypte in South African distribution pact.(International report)(Brief Article)
July 21, 2005... Calypte Biomedical (Pleasanton, California) reported signing an agreement with Adcock Ingram Scientific (Johannesburg, South Africa) for the marketing of its Aware rapid HIV antibody tests and HIV Incidence test in that country. With the...

MedMira expands in Latin America.(International report)(Brief Article)
July 21, 2005... MedMira (Halifax, Nova Scotia), a provider of rapid flow-through diagnostic tests, said it has expanded its market presence in Latin America with the completion of product registrations in Argentina, Panama and Peru. The company said...

Xenomics closes on $2.77m to support Tr-DNA R&D.(Financings roundup)
July 21, 2005... Xenomics (New York), developer of medical DNA technologies, reported closing a private placement of $2.77 million. The company said that the proceeds will support its efforts to develop diagnostics for a range of diseases and genetic...

Space walks to be measured in heartbeats by GE monitoring.
July 21, 2005... When you get up and walk, your heart rate naturally goes up a bit. And enquiring minds can't help but wonder what a heart does in the chest of an astronaut during a space walk. Then there's the associated excitement of seeing those...

NCI study: high rates of cervical cancer suggest access problem.(National Cancer Institute)
July 21, 2005... A National Cancer Institute (NCI; Bethesda, Maryland) report has found that high rates of cervical cancer are indicators of larger problems in access to healthcare, such as medical care access, cultural issues and health communication and...

New Lead Reported in Tumor Angiogenesis.(NIH Roundup)(Brief Article)
July 21, 2005... Scientists supported by the National Institute of Dental and Craniofacial Research, a unit of NIH, reported that they have added a key new piece to the puzzle of how tumor cells induce new blood vessels to form and fuel their abnormal growth....

Digene to record $7.5m charge to settle with Georgetown U.(Court report)
July 21, 2005... Digene (Gaithersburg, Maryland) reported entering an agreement with Georgetown University (Washington) to settle litigation, currently pending in the U.S. District Court for the District of Columbia. The litigation, initiated in October...

MicroFluidic adds $2m award for airborne agent detection.(Grants/contracts)(Brief Article)
July 21, 2005... MicroFluidic Systems (MFSI; Pleasanton, California) reported receiving a new $2 million dollar contract by the Homeland Security Advanced Research Projects Agency of the Department of Homeland Security to develop an Instantaneous Biological...

SourceOne Healthcare Technologies (Mentor, Ohio), a distributor of medical imaging systems, equipment and radiographic consumable, and iCAD (Nashua, New Hampshire).(Grants/contracts)(Brief Article)
July 21, 2005... SourceOne Healthcare Technologies (Mentor, Ohio), a distributor of medical imaging systems, equipment and radiographic consumable, and iCAD (Nashua, New Hampshire), a provider of computer-aided detection (CAD) solutions for the early...

Clarient (San Juan Capistrano, California), a cancer diagnostics services and technology company, and DakoCytomation (Glostrup, Denmark), a provider of cancer diagnostics and automated equipment, jointly reported a five-year distribution and development agreement.(Grants/contracts)(Brief Article)
July 21, 2005... Clarient (San Juan Capistrano, California), a cancer diagnostics services and technology company, and DakoCytomation (Glostrup, Denmark), a provider of cancer diagnostics and automated equipment, jointly reported a five-year distribution and...

SPO Medical closes reverse acquisition of United Diagnostic.(Brief Article)
July 21, 2005... SPO Medical (Woodland Hills, California), a developer of biosensor and microprocessor technologies for use in portable monitoring devices, reported completing its reverse acquisition of United Diagnostic and is now listed under the symbol...

Abbott.(Abbott Laboratories Inc. (Abbott Park, Illinois) appoints John Taylor III)(Brief Article)
July 21, 2005... John Taylor III has joined Abbott (Abbott Park, Illinois) as divisional vice president, federal government affairs. Previously, Taylor was associate commissioner at the FDA, where he was responsible for managing the Office of Regulatory Affairs...

Calypte Biomedical.(promotes Ronald Mink)(Brief Article)
July 21, 2005... Dr. Ronald Mink has been promoted by Calypte Biomedical (Pleasanton, California) to the position of chief science officer, replacing Dr. Toby Gottfried who retired in June. Gottfried was with Calypte since its inception in the late 1980s. Mink...

CombiMatrix Molecular Diagnostics.(appoints Matthew Moore)(Brief Article)
July 21, 2005... Cancer-based molecular diagnostics firm CombiMatrix Molecular Diagnostics (CMD; Irvine, California), a subsidiary of CombiMatrix, an Acacia Research company, appointed Matthew Moore, PhD, director of research and development; Robert Embree,...

Escalon Medical.(appoints Mark Karsch)(Brief Article)
July 21, 2005... Mark Karsch has been appointed CFO of Escalon Medical (Wayne, Pennsylvania). Karsch previously served as CFO of Multimedia Marketing Training Solutions, and from 1991 to 2003, he served as senior vice president and CFO for both private and...

E-Z-EM.(appoints Tom McLaughlin)(Brief Article)
July 21, 2005... Tom McLaughlin has been promoted to vice president-North America imaging sales for E-Z-EM (Lake Success, New York), a manufacturer of contrast agents for gastrointestinal radiology. He previously served as senior director-North America sales....

Fischer Imaging.(appoints Steven Durnil)(Brief Article)
July 21, 2005... Steven Durnil has been named president and CEO of Fischer Imaging (Denver), succeeding Harris Ravine, who resigned from the company as an officer and member of the board effective immediately. Ravine will continue to serve in a consulting...

Hitachi Medical Systems America.(Donald Broomfield)(Brief Article)
July 21, 2005... Donald Broomfield has been appointed president and CEO of Hitachi Medical Systems America (HMSA; Twinsburg, Ohio). Broomfield replaces Richard Ernst, who is retiring after serving as president and CEO of HMSA since 1989, when the company was...

PrognostiX.(appoints Mark Willig )(Brief Article)
July 21, 2005... PrognostiX (Cleveland), a start-up company established by The Cleveland Clinic, has named Mark Willig as its new CEO. Willig assumes his post July 18. Willig most recently was senior vice president of sales and marketing for Specialty Labs. He...

Radiologix.(appoints Carol Gleber)(Brief Article)
July 21, 2005... Carol Gleber has been named senior vice president and chief operating officer of Radiologix (Dallas), a provider of diagnostic imaging services. Gleber previously was president and chief operating officer of Care Support of America. From 2001...

Xillix Technologies.(appoints Rob Ngungu )(Brief Article)
July 21, 2005... Rob Ngungu has joined Xillix Technologies (Richmond, British Columbia) as vice president, quality, clinical and regulatory affairs. Ngungu has healthcare industry experience with J&J Ultrasound, Mesa Laboratories, Zimmer Arthroscopy, Baxter...

American Bio Medica.(Product Briefs)(Brief Article)
July 21, 2005... * American Bio Medica (ABMC; Kinderhook, New York), a manufacturer of immunoassay diagnostic test kits, said that the FDA has granted the company 510(k) clearance on its Rapid Reader, a personal computer peripheral that interprets, scans,...

Dade Behring.(Product Briefs)(Dimension Vista 1500 integrated system)(Brief Article)
July 21, 2005... Clinical diagnostics company Dade Behring (Deerfield, Illinois) said that its Dimension Vista 1500 integrated system, which will be the company's first integrated chemistry/ immunochemistry system targeted at high volume clinical laboratory...

DOBI Medical International.(Product Briefs)(Brief Article)
July 21, 2005... DOBI Medical International (Mahwah, New Jersey) said that it has entered into contracts with 17 U.S. sites in connection with its clinical trial studying its ComfortScan system. The ComfortScan system has been installed in 16 of those sites,...

Evisioneering Medical Technologies.(Product Briefs)(Brief Article)
July 21, 2005... Envisioneering Medical Technologies (St. Louis), a manufacturer of diagnostic and treatment technology, said a recent study confirms that TargetScan, a new FDA-approved targeted prostate biopsy and cancer treatment system, delivers improved...

Karl Storz Endoscopy-America.(Product Briefs)(Brief Article)
July 21, 2005... Karl Storz Endoscopy-America (Culver City, California) launched its Flex-X2 Uretero-Reno-Fiberscopes during this year's American Urological Association Annual Meeting in San Antonio. The company said the Flex-X2 Uretero-Reno-Fiberscopes offer...

BioImagene on track for diag version of Pathiam software.(Brief Article)
July 21, 2005... BioImagene (San Mateo, California) said it met earlier this month with members of the FDA Office of In Vitro Diagnostic Device Evaluation and Safety to discuss the regulatory pathway for commercialization of its Pathiam software product. ...

North American Scientific.(Product Briefs)(Brief Article)
July 21, 2005... North American Scientific (Chatsworth, California) reported that its Nomos Radiation Oncology division has received FDA 510(k) clearance to market nTRAK, its new stereotactic image guidance system used to position and monitor patients during...

Novadaq Technologies.(Product Briefs)(Brief Article)
July 21, 2005... Novadaq Technologies (Toronto), which is developing medical devices based on its imaging platform for the diagnosis and treatment of vascular and ophthalmic conditions, said that it has been granted a patent by the United States Patent and...

Roche Diagnostics.(Product Briefs)(Brief Article)
July 21, 2005... Roche Diagnostics (Indianapolis) reported that it has received FDA clearance for its Elecsys PreciControl Tumor Marker control solution. The tumor marker provides laboratory professionals with the same control for six different tumor marker...

Growing role for biomarkers in spectrum of cardiac care.
July 28, 2005... ORLANDO -- Introducing his talk on guidelines for assessing acute coronary syndrome and the usefulness of biochemical markers, Elliott Antman, MD, recalled his first patient as an intern. He has kept the notes on her condition upon presenting...

Potential for protein-based tests draws interested crowd.
July 28, 2005... ORLANDO -- Judging by the standing-room-only crowd at a session on new diagnostic frontiers in proteomics and metabolomics during the joint International Federation of Clinical Chemistry (IFCC; Milan, Italy)/American Association for Clinical...

Abbott gets CE mark for real-time PCR HCV test.(International report)
July 28, 2005... Abbott Laboratories (Abbott Park, Illinois) and Celera Diagnostics (Alameda, California) reported that Abbott Molecular has received CE mark certification for a real-time polymerase chain reaction (PCR) test for monitoring hepatitis C (HCV)...

Changes to delay EPIX trial of blood clot imaging agent.(EPIX Medical Inc.)
July 28, 2005... Concerns regarding patient safety have prompted EPIX Pharmaceuticals (Cambridge, Massachusetts) to amend the protocol for its ongoing Phase II study of EP2104R, an imaging agent to detect blood clots, and the trial's completion is expected to...

Senate committee eyes plan to stabilize FDA user fees.
July 28, 2005... WASHINGTON -- Medical device companies soon may be able to breathe a little easier when faced with FDA user fees. On July 20, a Senate committee took a big step forward in addressing the rising costs associated with the Medical Device User...

Misonix to spin off lab/science division to focus on devices.
July 28, 2005... Misonix (Farmingdale, New York) said last week that has set its sights on spinning off its Laboratory and Scientific Division in order to focus entirely on the development of medical devices. In unveiling the spin-off plan, the company said...

Higher outpatient payments due for diagnostics, imaging.(Washington roundup)
July 28, 2005... WASHINGTON -- The Centers for Medicare & Medicaid Services (CMS; Baltimore) has proposed payment rate changes in the Outpatient Prospective Payment System (OPPS) rule for acute-care hospitals that would have an impact on payment rates for...

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