Polysciences Offers New Service
Polysciences Inc has begun a new custom-formulation service to formulate and supply fixatives needed for specific applications by histologists, histotechnicians, biologists, pharmaceutical scientists, forensic pathologists, and researchers.

Purchasing the fixatives premixed, prebuffered, and pH-balanced for immediate laboratory use is meant to save time. Polysciences will collaborate with histologists to formulate and supply the fixatives needed for their specific application, even in small quantities. A full in-house histology lab and staff of chemists, and collaborative partnerships with universities and hospitals, enable Polysciences to develop these solutions at a faster rate.

“Until now, technicians needing specialty fixatives had no choice but to mix their own because the big lab supply companies didn’t want to be bothered developing low-volume, custom batches,” says Dana Dittus, histology business development manager of Polysciences Inc. “This new service offering from Polysciences lets histologists spend their valuable time executing histology procedures instead of looking for ‘recipes’ and mixing batches of fixatives. The bottom line is increased, high-quality lab output.”

Contact: Polysciences Inc (800) 523-2575; www.polysciences.com

CRP Latex Assay Receives FDA Clearance
 The US Food and Drug Administration (FDA) recently approved Olympus’ C-reactive protein (CRP) latex assay as an independent cardiac risk marker. The assay is expected to be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or acute coronary syndrome, when used in conjunction with traditional clinical laboratory evaluations.

The Olympus CRP latex assay offers three applications covering a variety of measuring ranges to quantify CRP in human serum. The ranges include normal (5 – 170 mg/L), sensitive (cardiac) (0.5 – 20 mg/L), and highly sensitive (neonatal) (0.05 – 2.00 mg/L). C-reactive protein is one of the most sensitive acute-phase reactants. Measurement of CRP can have a role in the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated disease.

The Olympus CRP latex assay is designed for use with Olympus’ full line of chemistry-immuno analyzers.

Contact: Olympus Diagnostic Systems Group (800) 223-0125; www.olympusamerica.com

Nanogen Invests in Jurilab
Nanogen Inc has acquired certain rights from Jurilab Ltd to develop diagnostic products based on genes and gene-metabolic diseases, including diabetes.

 Additionally, Nanogen will become a distributor of Jurilab’s pharmacogenomic products and services. Nanogen will now have the rights and access to the collection of DNA samples and phenotypic data from the East Finland founder population.

Jurilab’s Blockmap™ genetic-discovery platform could potentially support programs in more than 30 disease indications. The partnership will provide Nanogen with proprietary diagnostic markers for identifying predisposition to disease and pharmacogenetic testing for drug responses.

“This investment in Jurilab is an important part of our strategic operating plan to secure access to important molecular targets for advancing the use of diagnostics and personalizing health care,” says Howard C. Birndorf, Nanogen chairman and chief executive officer. “Jurilab’s programs in cardiovascular diseases, diabetes, and related pharmacogenomics match our own commercial product programs. Working together, we can accelerate development of products for the growing molecular-diagnostic market.”

Founder populations, such as the one used in Jurilab’s DNA studies, are excellent resources for genetic studies because their high degree of homogeneity makes them ideal for the discovery of disease-linked gene mutations. The data Jurilab has collected addresses underlying causes of common diseases and those factors that contribute to disease progression or disease complications.

The partnership will provide Nanogen with a source of proprietary diagnostic markers for use in identifying the predisposition to disease and pharmacogenetic testing for related drug responses.

Contact: Nanogen Inc (877) NANOGEN; www.nanogen.com

Glasgow Health Board Chooses Abbott Diagnostics as Supplier
Abbott has been named supplier for the Greater Glasgow Health Board (GGHB). The 7-year deal allows Abbott to provide its ARCHITECT® and Accelerator™ instruments, tests, lab automation, and other laboratory services to the board’s hospitals.

 “Abbott will provide services covering all disciplines of the laboratory, including biochemistry, osmometry, blood grouping, coagulation, allergy, and other testing supplied through partnerships established by Abbott. This is the first contract of this nature and volume in the United Kingdom,” says Tom Divers, CEO of GGHB. “Additionally, Abbott’s ability to supply a wide selection of diagnostic instrument configurations to best meet our adult and pediatric hospital testing needs was a key part of this agreement and will allow us to standardize processes and compare results across our seven hospitals.”

This agreement cements the largest ARCHITECT® placement to date in Europe. Abbott offers a broad range of instrument systems and tests to many segments of the diagnostics market, including hospitals, reference labs, blood banks, physician’s offices, clinics, and consumers.

Contact: Abbott Diagnostics (847) 937-6100; www.abbott.com

Millipore and Gen-Probe Join to Develop Molecular Tests
Millipore Corp and Gen-Probe have formed a collaboration to develop, manufacture, and commercialize nucleic acid testing (NAT) products on an exclusive basis for quick microbiological and virus monitoring in the biotech and pharmaceutical industries.

Millipore’s sample-preparation technology isolates microorganisms from large volumes of fluid while Gen-Probe’s NAT technology amplifies and detects miniscule quantities of microorganism-specific RNA in hours or less. The companies believe the combination of both technologies will make for rapid molecular-based microbiological testing in biotech and pharmaceutical manufacturing. Microbiological monitoring of manufacturing processes is critical for ensuring patient safety and meeting regulatory requirements.

“Our biotech and pharmaceutical customers are looking for more rapid and sensitive microbiological testing methods,” says Martin Madaus, chairman, CEO, and president of Millipore. “These new products will enable our customers to reduce the time-to-result of biological testing from days or weeks to hours, and thus greatly improve production efficiency.”

The terms of the agreement state that Gen-Probe will be primarily responsible for assay development and manufacturing, while Millipore will manage worldwide commercialization. The companies expect a launch date in 2007 for the first in a series of new rapid biological testing products.

Contact: Gen-Probe (800) 523-5001; www.gen-probe.com and Millipore Corp (800) MILLIPORE; www.millipore.com

Trestle Holdings Expands Remote Microscopy to Mexico
The American British Bowdray (ABC) Medical Center in Mexico City has installed Trestle Holdings Inc’s Internet-microscopy solution.

 The Web-based slide-viewing system facilitates viewing of high-quality digital images of patients’ specimens by medical personnel via a standard PC. Physicians in different locations can view a patient’s slide simultaneously and collaborate in real time.

“The Trestle MedMicro system will provide immediate interactive consultation regarding surgical-pathology specimens,” says Carlos Ortiz, MD, director of pathology at the ABC hospital. “This will result in more efficient collaboration between the hospitals and improved health care for patients.”

The hospital purchased Trestle’s MedMicro through Ad Astra International Inc (AAII). Trestle maintains a nonexclusive sales-agent relationship with AAII, which operates throughout Mexico and Central America.

Contact: Trestle Corp (800) 823-3203; www.trestlecorp.com

CeMines Files FDA Application for CellCorrect LAb Detection Test Kit
CeMines Inc announced it has filed a 510(k) application with the US Food and Drug Administration (FDA), seeking clearance for clinical use of the company’s minimally invasive cancer-detection kit, the CeMines CellCorrect™ LAb Detection Test Kit.

 The new test detects altered autoimmunity and associated patterns of disease-related autoantibodies in the bloodstream. Clinical studies conducted by the company have demonstrated specific and consistent patterns of antibodies proving their utility as composite biomarkers to characterize cancer, therefore making them useable as diagnostic tests for the disease.

CeMines uses a proprietary bioinformatics-based statistical-pattern-recognition application, CeMines Molecular FingerPrinting™, which evaluates patterns of certain antibodies and the profiles of cancer patients.

“We believe our approach to diagnostic testing is the only practical approach to achieving an accurate determination of clinical prognosis, as well as a precise measurement of a patient’s response to treatment,” says Roger Attick, CEO of CeMines. “The team at CeMines is dedicated to achieving advancements in research and technology that we hope will forever change cancer’s sad legacy, so that the victims of this disease will never again have to say, ‘If only we’d caught it sooner.’ ”

Contact: CeMines Inc (303) 526-3700; www.cemines.com

Precision Dynamics and Novation Sign Labor and Delivery Contract
Precision Dynamics Corp (PDC) and Novation have signed a dual-source contract to provide members access to PDC labor and delivery products, including amniotic membrane perforators, umbilical cord clamps, and baby footprinters. The contract, which took effect March 1, will continue through February 28, 2008.

PDC and Novation have a separate agreement for PDC’s automatic wristband-identification product.

Contact: Precision Dynamics Corp (818) 897-1111; www.pdc-healthcare.com

Elecsys CA 19-9 Tumor Marker Gets FDA Clearance
The US Food and Drug Administration (FDA) recently cleared Roche Diagnostics’ test for the management of pancreatic cancer, the Elecsys CA 19-9. The test helps physicians monitor patients who receive treatment for cancers of the exocrine pancreas. The new test provides a wide measuring range that gives physicians more confidence in patients’ results.

The measuring range of the Elecsys CA 19-9 test, combined with its high precision, helps to provide more reliable information to physicians and could be used to monitor the therapeutic responses.

“The approval of CA 19-9 adds to an already extensive menu of tumor markers, providing Roche Diagnostics’ customers with a thorough menu of tumor markers for their laboratories,” says Andy Thomson, senior vice president of Centralized Diagnostics at Roche.

Contact: Roche Diagnostics (800) 428-5030; www.roche.com

Axis-Shield Grants Abbott Exclusive Distribution Rights for AFINION System
Abbott Laboratories and Axis-Shield plc announced their partnership plans for the AFINION™ system, an immunoassay instrument designed for use in physician’s office labs and hospital point-of-care settings that offers tests for a variety of medical conditions. The system received clearance from the US Food and Drug Administration in July.

The agreement names Abbott as the exclusive distributor of the AFINION instrument and test cartridges in the United States. Additionally, Abbott will supply certain AxSYM® and IMx® reagents to Axis-Shield to accelerate expansion of the AFINION line.

“As demand grows for increased access to immediate test results, the role of physician’s office laboratories will continue to expand in the United States,” says Michael J Collins, vice president of Abbott’s US Commercial Operations. “This agreement allows us to add a point-of-care instrument with a test for diabetes that should be appealing for physician’s offices, clinics, and other point-of-care settings.”

Contact: Abbott Laboratories (800) 323-9100; www.abbott.com

CeMines and CHBI Enter Product-Distribution Agreement
 CeMines Inc and Colorado Heart & Body Imaging (CHBI) LLC have joined together in a product-distribution agreement for CeMines’ CellCorrect™ LAb Detection Test Kits. The new alliance allows CHBI to use the kits in upcoming clinical studies that relate patient-serum biomarkers and imaging in diverse and healthy population groups, and detect altered autoimmunity and associated patterns of lung cancer-related autoantibodies present in the bloodstream.

“Our relationship with Colorado Heart and Body Imaging leverages complementary technologies that, when combined, provide a powerful multimodality diagnostic tool,” says Roger Attick, CEO of CeMines. “This initiative holds great potential for earlier detection of lung cancer.”

CeMines conducted international clinical studies that have demonstrated that specific and unique patterns of certain human antibodies regularly prove their utility as composite biomarkers to characterize lung cancer—and can therefore be used as a tool, complementing other technologies like imaging, for use in lung-cancer diagnosis. CeMines uses a proprietary (patent-pending) bioinformatics-based pattern-recognition platform, CeMines Molecular FingerPrinting™. The company’s cancer-biomarker libraries are used to evaluate the presence of autoantibody biomarkers as well as specific antibodies that are useful in profiling cancers.

“As the nation’s most technologically advanced and versatile screening center, we are proud to add the CellCorrect LAb test to our impressive arsenal of ‘best of breed’ early-detection technologies,” says James Ehrlich, MD, medical director and founder of CHBI. “I am confident that early detection efforts, combining electron beam tomographic imaging with CellCorrect LAb specific serum biomarkers, should favorably change the prognosis for thousands.”

Contact: CeMines Inc (858) 964-2200; www.cemines.com

ASCP Given $1.5 Million to Help With AIDS Relief
The US Department of Health and Human Services Centers for Disease Control and Prevention (HHS/CDC) gave the American Society for Clinical Pathology (ASCP) approximately $1.5 million to assist the AIDS relief effort in Africa.

The ASCP deal is part of the larger total package of the President’s Emergency Plan for AIDS Relief, the largest commitment by a nation toward an international health initiative for a single disease in history—a 5-year, $15 billion, multifaceted approach to combating the disease in more than 100 countries around the world.

The deal was announced at a media news briefing September 14 at the Fitzpatrick Chicago Hotel by ASCP President LoAnn C. Peterson, MD, FASCP, and ASCP Institute for Research Acting Director Theresa M. Somrak, JD, CT.

Contact: The American Society for Clinical Pathology (312)738-1336; www.ascp.org

Gen-Probe Receives FDA Clearance for STD Testing Using Cytyc System
The US Food and Drug Administration (FDA) has granted marketing clearance to use Gen-Probe’s APTIMA Combo 2® assay to test for Chlamydia trachomatis and Neisseria gonorrhoeae from liquid Pap specimens collected and processed with Cytyc’s Thin Prep® 2000 System.

“This new indication for the APTIMA Combo 2 assay adds to the comprehensive solution that Gen-Probe offers customers for STD testing,” says Steve Kondor, vice president of sales and marketing for Gen-Probe. “In addition, it provides physicians the convenience of intercepting Chlamydia infections and gonorrhea in conjunction with the ThinPrep Pap Test, thereby preventing potentially serious medical complications and avoiding unnecessary health care costs.”

“This FDA approval again reinforces the unique advantages of the ThinPrep Pap Test collection vial as a platform for improved patient management,” says Daniel J. Levangie, Cytyc’s executive vice president. “Gen-Probe is the industry leader for Chlamydia and gonorrhea testing, and we believe combining this testing with the ThinPrep Pap Test will lead to increased implementation and adoption of these important preventive health technologies.”

According to the Centers for Disease Control and Prevention (CDC), Chlamydia infections and gonorrhea are the two most common bacterial STDs. Approximately 4 million cases of Chlamydia and 1 million cases of gonorrhea are diagnosed annually in the United States. These infections are often asymptomatic in both men and women. If left untreated, they can lead to serious complications, including pelvic inflammatory disease and ectopic pregnancy in women, and infertility in both men and women. However, early diagnosis and treatment can both be medically and economically efficient.

The APTIMA Combo 2 assay is cleared to detect Chlamydia infections and gonorrhea from a wide variety of sample types. In addition to ThinPrep specimens, these sample types include clinician-collected endocervical, vaginal, and urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens.

In the United States, approximately 50 million women receive an annual Pap test for cervical cancer. However, the conventional Pap smear has limited sensitivity and suffers from a large proportion of inadequate specimens. The ThinPrep Pap Test was developed to address these limitations, and is the only liquid-based cytology method approved by the FDA as “significantly more effective” than the conventional Pap smear for the detection of cervical abnormalities. As a result, the ThinPrep Pap Test is the most commonly used method for cervical cancer screening in the United States.

Contact: Gen-Probe Inc (800) 523-5001; www.gen-probe.com

 Bayer and CIS Biotech Join to Develop Assays for Stroke Diagnosis
Bayer HealthCare Diagnostics Division and CIS Biotech Inc have announced they have signed an exclusive development and license agreement deal. The two companies will collaborate on the commercialization of automated serum assays for stroke testing based on CIS Biotech’s proprietary immunoassays for NMDA NR2 receptor and antibodies.

“Bayer recognizes that there is a tremendous unmet need for more accurate and accessible diagnosis of stroke and is very excited by the potential to significantly impact the health of stroke patients by bringing this unique biomarker to market,” says John Blackwood, vice president for Global Business Development in the diagnostics division of Bayer HealthCare.

Bayer and CIS Biotech will work together to develop and commercialize the NR2 assays for use on Bayer’s ADVIA Centaur® line of automated immunoassay systems, as well as future Bayer systems.

Contact: Bayer HealthCare Diagnostics Division (914) 631-8000; www.bayerdiag.com

POH Medical Center Uses Misys CPR System
POH Medical Center (Pontiac, Mich) has begun using Misys Healthcare Systems’ CPR™ integrated computer-based patient record; it will be used by approximately 1,000 employees and associates—including physicians, residents, medical students, nurses, student nurses, clinicians, IT analysts, and clinical and nonclinical support staff—across the facility, including nine inpatient units and two emergency departments.

The facility chose Misys CPR to achieve its ultimate goal of a paperless environment by automating patient-care documentation into a single electronic record. The solution will eliminate clinical and business work-flow redundancies, streamline nursing documentation, and improve multidisciplinary communications.

During this first phase, which is to last 13 months, health care professionals will access the Misys CPR electronically to communicate and coordinate care during a patient’s visit, beginning with scheduling, registration, and clinical care through discharge.

“POH Medical Center sought a swift deployment in order to replace our clinical system no longer being serviced,” says Bruce Kelly, CPHIMS, chief information officer of the facility. “From the initial project kickoff to go live, this 13-month rollout reinforced Misys’ commitment to a rapid implementation that was in our contract and a prerequisite for success.”

Contact: Misys Healthcare Systems (866) MISYS-US; www.misyshealthcare.com

 AACC Helps Katrina Victims
The American Association for Clinical Chemistry (AACC) has created a Web site to help coordinate clinical laboratory-related relief efforts for the victims of Hurricane Katrina. Two key laboratory groups, Labs that Need Help and Labs and Lab Professionals Offering Help, will communicate with each other regarding exchanging resources and assisting each other.

In addition to a list of labs offering assistance and labs in need of assistance, the Web site lists labs or companies offering jobs for those outside the affected area. It also links to sites like the Red Cross and the Salvation Army for victims or those looking to make a donation.

The site is located at: www.aacc.org/katrina_labrelief/index.cfm. Suggestions for other resource links may be directed to AACC Director of Internet Programs Lurene Haines.

Contact: The American Association for Clinical Chemistry (202) 857-0717; www.aacc.org

 JCAHO and WHO Collaborate on International Patient Safety Center
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), its international consulting and accreditation division, and the World Health Organization (WHO) have announced they will work together on an international patient safety center.

The WHO Collaborating Centre will be the world’s first facility focused solely on patient safety. Its goal will be to reduce the “unacceptably high numbers of serious medical injuries around the world each day,” according to the JCAHO. The center will collaborate with ministries of health, patient-safety experts and agencies, health care professional associations, and consumer organizations to coordinate international efforts on best practices.

The Joint Commission International Center for Patient Safety, launched earlier this year by JCAHO and Joint Commission International, will further the effort by creating partnerships with leaders in developing and developed countries to determine health care safety needs and find corresponding “proven solutions and best practices.”

Contact: The Joint Commission on Accreditation of Healthcare Organizations (630) 792-5000; www.jcaho.org.

Abbott Pledges $4 Million for Katrina Relief Effort
Abbott Laboratories has pledged $4 million in donations ($2 million in funds and $2 million in nutritional and medical products) to help the Hurricane Katrina aid efforts in the Gulf Coast.

 “The effects of this disaster are absolutely devastating,” says Miles D. White, Abbott’s chairman and CEO. “Abbott is answering the call to assist in the aftermath of Hurricane Katrina. Our thoughts are with all of those who live in the affected areas. We encourage all of corporate America to help.”

The company dispatched Architour trucks to the Reliant Center in Houston and other sites in the Gulf states to aid evacuees and serve as mobile labs. The trucks are equipped with the ARCHITECT® ci8200® System and CELL-DYN instruments to perform immunochemistry and hematology testing. Also on hand are the Abbott i-STAT® point-of-care systems, giving health care workers greater flexibility in getting directly to those in need.

The company’s first donations to the relief effort included working with the American Red Cross, AmeriCares, America’s Second Harvest, and MAP International to give pediatric and adult nutritional products to Katrina’s victims.

Contact: Abbott Laboratories (800) 323-9100; www.abbott.com

 ToxCup Drug Screen Cup Achieves CLIA-Waived Status
Branan Medical Corporation’s ToxCup® Drug Screen Cup has achieved Clinical Laboratory Improvement Amendments (CLIA)-waived status. The ToxCup is a one-step test for the rapid detection of up to seven drugs of abuse, integrating sample collection, drug testing, and shipping for confirmation in a single container.

CLIA-waived status indicates that the test is easy enough to be used by laboratory and nonlaboratory personnel at point-of-care sites such as treatment centers, occupational medicine departments, hospital laboratories, physician’s offices, probation/parole agencies, prisons, and the workplace.

This is the only test cup for the following abused drugs: amphetamine, barbiturates, benzodiazepines, cocaine, MDMA, methamphetamine, methadone, opiates, oxycodone, PCP, and THC.

Using the ToxCup requires no instrumentation. After the specimen is in the cup and the lid is attached, the cup is leaned onto its side to activate the testing. Five minutes later, the test results are ready.

ToxCup® comes 25 in a box and is available in five, six, or seven drug configurations, depending on the facility’s needs. The tests’ shelf life is 18 months; the test cups can be stored at room temperature.

Contact: Branan Medical Corporation (949) 598-7166; www.brananmedical.com

Nova Biomedical Awarded 3-Year Contract with Premier Inc
Premier Inc has selected Nova Biomedical Corp to provide its members with advanced point of care/blood gas instruments and related products as part of a 3-year contract. The terms of the agreement, which began October 1, include all of Nova’s qualifying equipment, including the Stat Profile® Critical Care Xpress and pHOx® series, related connectivity options, reagents, and consumables, as well as service agreements. This is the first contract between the two companies.

“We are extremely happy that Premier’s laboratory committee selected Nova Biomedical for our point of care/blood gas testing analyzers and connectivity solutions,” says Scott Fine, director of US corporate sales for Nova Biomedical.

Contact: Nova Biomedical Corp (800) 545-6682; www.novabiomedical.com

Upgraded Cystic Fibrosis Test is Launched
Tm Bioscience Corp has announced that Genzyme Genetics launched its upgraded CFplus™ cystic fibrosis mutation analysis, which incorporates technology from Tm Bioscience and includes testing for 97 mutations.

 “Our collaboration with Genzyme Genetics has produced one of the most innovative and technically advanced products available in the area of molecular diagnostics, made possible through our proprietary Tag-It™ platform,” says Greg Hines, president and CEO of Tm Bioscience. “This collaboration affirms that Tm is the partner of choice for the commercialization of genetic tests that meet the highest quality standards.”

Tm Bioscience’s Tag-It™ Cystic Fibrosis Kit is the first multiplexed human disease genotyping test to be cleared by the US Food and Drug Administration as an in vitro device for diagnostic use in the United States. All of the company’s genetic tests are based on the Tag-It™ Universal Array platform, which uses a proprietary universal tag system that allows for easy optimization, product development, and expansion.

Contact: Tm Bioscience Corp (416) 593-4323; www.tmbioscience.com

 Value/Barriers of Diagnostics in Health Care Increasing
Patients and physicians are becoming increasingly reliant on advanced diagnostics when making health care decisions, yet significant barriers discourage the use of new tests, according to a report released by the Lewin Group.

“Scientific breakthroughs, such as the development of molecular diagnostic tests, are driving the movement toward personalized medicine,” says Stephen J. Ubl, AdvaMed president and CEO. “It is time for a fundamental re-examination of the 20-year-old Medicare payment system that was built for the science of yesterday to ensure that the predictive value being added by these tests is being recognized and that the patients have access to the best treatment road map science has to offer.”

The Lewin Group says, “Although diagnostics comprise only a small fraction of total hospital (under 5%) and Medicare (1.6%) costs, diagnostic information influences a much larger proportion of downstream health care decision-making, resulting in improved health outcomes and net cost savings in many instances.”

The report highlights the various ways diagnostics influence patient care, including assessing disease risk sooner; detecting and diagnosing disease earlier, faster, and more accurately than ever before—long before symptoms occur; selecting more targeted, effective, and often less invasive treatments; closely estimating patient prognosis; and managing chronic disease effectively.

“With the potential to fundamentally alter clinical practice, these technologies are intended to match the ‘right patient with the right treatment at the right time,’ ” the report states. “The expanding body of evidence-based clinical practice guidelines substantiates the critical role of diagnostics in health care decision-making.”

The authors of the report identified and examined more than 1,230 guidelines and found that half recommend specific diagnostic tests. “Evidence-based guidelines specify using diagnostics in the standard of care for 12 of the 15 most clinically and economically burdensome disease/condition categories in the United States,” states the report.

However, the Lewin Group cites evidence from a RAND Corporation study that states many diagnostics that are recommended as standards of care and supported by clinical evidence are grossly underused in practice 51% of the time. The authors maintain that this underuse has significant implications for quality and the cost of care.

To support this assertion, the report states that data from the National Committee for Quality Assurance indicate that, “Low compliance with diagnostics-based quality measures for diabetes, cardiovascular disease, colorectal cancer, and breast cancer alone was linked to 56,200 avoidable adverse health events, nearly 34,000 avoidable deaths, and $899 million in avoidable health care costs in 2004.”

The Lewin Group concludes that Medicare payment policies for new diagnostics are “archaic, impractical, and severely flawed,” and fail to “reflect the relative value of diagnostics to health care.” It asserts that Medicare often pays the same or less for a new test than an existing test, even though that new test may offer greater benefits to patients and physicians.

Other findings of the report include:

  • The Medicare Clinical Laboratory Fee Schedules (CLFS) has not been updated for inflation in 13 of the last 15 years and will not be updated again until after 2008;
  • Each dollar paid in 2004 under the CLFS is equivalent to $.75 in 1984 dollars after adjusting for inflation and mandated payment reductions; and
  • Medicare coding and payment processes are time-consuming, lack transparency, and are inconsistently applied.

Furthermore, the report states that physicians and laboratories have little incentive to prescribe and use newer diagnostics technologies because both incremental and breakthrough advances are underpaid. It says that this creates patient barriers that affect more than the nation’s 40 million Medicare beneficiaries because Medicaid or private health insurance plans often base their diagnostics payment levels on Medicare.

The report concludes with several solutions. The Lewin Group recommends that Congress and the Centers for Medicare and Medicaid Services take prompt action to modernize the CLFS with steps including creating a single national payment schedule with an open, systematic, and accountable process that would reduce wide pricing variations; correcting historic pricing and coding errors; clarifying processes and criteria for incorporating new tests into the CLFS; developing and implementing a value-based payment system for diagnostics (in parallel with the above recommendations) that better recognizes the clinical, economic, and other benefits of improved diagnostic testing; and allowing for more public stakeholder input into pricing and coding decisions.

The full report is available for download at http://www.advamed.org/publicdocs/july2005hillbriefing.shtml.

Contact: AdvaMed (202) 783-8700; www.advamed.org

New Test for Prostate Disease Being Developed by Beckman Coulter
A new blood test may help identify benign prostatic hyperplasia (BPH), according to early research that was presented at a joint meeting of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the American Association for Clinical Chemistry (AACC), held during July in Orlando.

Beckman Coulter Inc is developing the new laboratory test, BPH-A, for use on the company’s Access family of immunoassay systems. The test detects an isoform of prostate-specific antigen (PSA), which exists in abnormally high levels in the blood of men who have an enlarged prostate gland. According to the study presentation, BPH-A appears to be more specific to BPH than more traditional prostate disease markers like PSA.

“While today’s current PSA test is useful as an aid in the early detection and monitoring of prostate cancer, the test alone is not an effective means to detect and diagnose BPH, because elevated levels may be indicative of other prostatic conditions such as prostatitis and prostate cancer,” says study coauthor Bernard Cook, PhD, DABCC, manager of scientific and professional relations for Beckman Coulter. “Until now, there hasn’t been an assay that is specific to BPH. This test is potentially the first of its kind.”

 Four out of five men develop BPH, a noncancerous condition caused by enlargement of the prostate gland that usually develops later in life. The growth constricts the urethra, causing urination problems.

A “research use only” version of BPH-A is currently being developed by Beckman Coulter and will be used by select researchers to further study the test’s usefulness, says Cook. The company expects the studies to be completed by the end of this year.

“Optimal management of a condition like BPH can only begin after a physician definitively identifies the condition,” says Cook. “It would be a major step forward in prostate disease diagnosis and management if the feasibility studies confirm a clinical value for BPH-A.”

Contact: Beckman Coulter Inc (800) 352-3433; www.beckmancoulter.com

Nanogen To Release Congestive Heart Failure Test
StatusFirst™, Nanogen’s point-of-care congestive heart failure test, is set for launch by the end of the year. Customers will be able to choose between rapid tests that measure brain natriuretic peptide (BNP) or N-terminal atrial natriuretic peptide (NT-proBNP), cardiac biomarkers from the natriuretic peptides. StatusFirst is unique in that it also uses NT-proBNP, while others currently used only measure BNP.

A study published in the European Journal of Heart Failure concluded that patients with severe congestive heart failure who have elevated levels of NT-proBNP have a higher risk of 1-year mortality. The study gauged N-terminal atrial natriuretic peptide (NT-proAnP), BNP, and NT-proBNP and found all to be significant individual predictors of 1-year mortality. Additionally, the study showed that the risk of mortality from congestive heart failure could be more accurately ascertained if levels of NT-proBNP are known, even after accounting for other important clinical variables, such as the severity of heart failure.

“By developing a point-of-care diagnostic utilizing this marker, Nanogen takes another step forward in its mission to bring diagnostic tools that improve accessibility and quality of information available to health care providers so that they can select the appropriate course of therapy and potentially extend the lives of patients,” says Howard C. Birndorf, Nanogen’s chairman of the board and CEO.

Contact: Nanogen (877) NANOGEN; www.nanogen.com

New Research Could Signal the End of Long-Term Painkiller Use by Osteoarthritis Patients
New research by a team at the University of Michigan could lead to early-stage diagnosis of osteoarthritis. The project, funded by the US National Institute of Health, is investigating ways to use surface enhanced raman spectroscopy (SERS) to identify levels of hyaluronic acid (HA) in blood. If further tests are successful, detection of osteoarthritis would be possible before mechanical damage to the knee occurs, eliminating the need for long-term pain management.

The research was possible through the development of a new SERS substrate by Mesophotonics Ltd, Klarite, which enables faster and more accurate analysis of biological and chemical samples at lower detection limits. As a result, Gluconate and glucosamine, which make up the polymer in HA, can now be detected.

“Gluconate and glucosamine only achieve very weak Raman scatters and were impossible to identify on previous SERS substrates,” says Professor Mike Morris, the head of the project for the Muscular Skeletal Disorder Unit at the University of Michigan. “The signals generated by the Klarite substrate are many orders of magnitude more intense than traditional Raman signals, making research such as this possible.”

Klarite offers excellent levels of reproducibility, according to Morris. The substrates are mounted on standard 3-inch glass slides, allowing the unique Raman fingerprint in all molecules to be easily and repeatedly identified. Compatible with existing Raman instruments, Klarite has significant implications for researchers in a variety of pharmaceutical and biomedical areas as well as in forensics, homeland security, and analytical chemistry.

The initial phase of this research, presented at a Royal Society of Chemistry meeting in England last month, showed this potential to develop a candidate for a biomarker for osteoarthritis. These findings could enable clinicians to include a test for HA alongside other normal blood work.

Contact: Mesophotonics Ltd +44 (0)23 8076 3752; www.mesophotonics.com