Igen acquires improved diagnostic test for acute thrombosis
Igen Int., Inc. has acquired exclusive rights from the University of California to a proprietary test and related technology designed to improve the diagnosis and medical care of patients with venous thromboembolic (VTE) disease, which includes deep vein thrombosis (DVT) and pulmonary embolism.

The test technology involves the measurement of a biomolecular marker, known as FPB, which is produced during thrombosis, or clot formation. The licensed technology is being combined with Igen’s proprietary Origen technology to create a clinical test kit for the rapid and accurate diagnosis of DVT and pulmonary embolism.

Igen is currently sponsoring a clinical study designed to establish FPB as a viable diagnostic marker for VTE disease. The principal investigator for the study is Dr. Timothy A. Morris, the inventor of the technology and an associate professor of pulmonary and critical care medicine at the University of California, San Diego Medical School. The study employs an Origen-based immunoassay that detects and quantifies FPB in patient blood and urine samples. Results from preclinical and preliminary clinical studies indicate that FPB levels are significantly elevated in the urine and blood of patients with DVT. In addition, FPB levels have been found to be elevated when a clot moves from the leg veins to the lungs, suggesting that the test may be effective for the early detection of pulmonary embolism, an often fatal condition.

Deep vein thrombosis occurs when a blood clot forms in the veins of the leg, and pulmonary embolism results when such a clot dislodges and blocks blood flow through the lungs, leading to respiratory distress. It has been estimated that as many as 600,000 cases of DVT and pulmonary embolism occur in the United States each year. Fewer than half of these cases are ever diagnosed and treated. About 50,000 people die from pulmonary embolism each year in the United States. Approximately 80% of these fatal cases go undiagnosed since symptoms associated with pulmonary embolism such as chest pain and shortness of breath are not specific to the disorder.

A sensitive and specific urine- or blood-based test for diagnosing both DVT and pulmonary embolism would offer significant advantages over existing non-invasive tests for VTE disease, which lack the ability to detect active thrombosis and have limited clinical specificity. The current standards for diagnosing VTE disease, venous and arterial imaging, are expensive and invasive procedures that require the injection of potentially harmful dyes. Some of the potential applications of a blood- or urine-based test for VTE disease would be the screening of high-risk patients, early disease detection and the monitoring of patients who have already been diagnosed with VTE disease and are receiving anticoagulant therapy.

ARUP & Scantibodies partner on an improved parathyroid test
ARUP Laboratories and Scantibodies Clinical Laboratory have announced they are partnering to deliver improved parathyroid disease testing to help doctors more accurately identify patients with primary hyperparathyroid disease and monitor secondary hyperparathyroid disease in dialysis patients.

For 25 years Scantibodies has been an innovator in the development of parathyroid hormone (PTH) tests that are used to detect and monitor parathyroid diseases. Their third-generation PTH tests are available under the marks CAP, CIP and CAP/CIP ratio.

Under this joint agreement, ARUP will be responsible for marketing and servicing this new technology and will collect and report results on patient samples from across the nation. Scantibodies will then perform a series of third-generation parathyroid hormone assays on these patient samples.

“We are pleased to be taking this expansion step forward with our improved PTH technology,” says Tom Cantor, president of Scantibodies. “The collaboration with ARUP Laboratories allows physicians and ultimately patients a broader access to the clinical benefits of this improved diagnostic technology.”

In the United States, 50,000 people each year are diagnosed with primary hyperparathyroid disease. Using the CAP assay, physicians may now detect over 90 percent of patients with even mild forms of primary hyperparathyroidism. Statistics available from studies show that the CAP assay has less overlap between normal and mild hyperparathyroidism, resulting in an improved detection rate of 96 percent, compared to the older second-generation intact PTH assay of 72 percent.

Additionally, the over 300,000 patients receiving dialysis in the United States each year require accurate assessment of bone turnover and parathyroid function prior to treatment of secondary hyperparathyroidism. Scantibodies’ CAP/CIP ratio assay provides relative levels of authentic PTH and its inhibitor. For a patient who is not yet receiving bone-affecting treatment, a CAP/CIP ratio of less than one indicates that he or she has a dynamic low bone turnover disease, and consequently should not be placed on vitamin D analog treatment. A ratio of one or greater indicates that the patient has normal or high bone turnover and can be considered, if necessary, for vitamin D analog treatments.

Moreover, following treatment, physicians may avoid oversuppression by monitoring the level of CIP. CIP and the CAP/CIP ratio assays are significantly more accurate than the second-generation intact PTH assay, and may help physicians better stratify treatment to decrease conditions of soft tissue and vascular calcification, which are leading causes of complications and death for dialysis patients.

Sunquest FlexiLab chosen by BryanLGH Medical Center
BryanLGH Medical Center in Lincoln, Neb., has chosen Tucson, Ariz.-based Sunquest Information Systems’ FlexiLab Laboratory Information System for its LIS.

"In our analysis of Laboratory Information Systems, we found FlexiLab to be the product which best met the complex requirements of our organization," said Gary Welch, director of information technology.

Sunquest’s LIS integrates information and images into one electronic source that consists of: a Microbiology test ordering and results reporting application; Lab Access Results, a user-customizable patient specimen testing module; Ad Hoc Report Writer; and Outreach, which helps hospitals entering service contracts with physicians, clinics and managed care organizations.

Capabilities include: standing order entry; rapid order entry; duplicate data entry; full client database; courier route management; client calls; requisition based reports; requisition (number) printing and fax on demand.

AMA approves new CPT code for serum HER-2/NEU test
Bayer Diagnostics announced that the American Medical Association last month approved a unique Current Procedural Terminology (CPT) code for the serum HER-2/NEU oncoprotein test.

The test is the first in a new category recognizing the measurement of “oncoprotein” as critical to cancer patient treatment and overall care. The HER-2/NEU oncoprotein can be elevated in the blood of women with metastatic breast cancer and changes in concentration reflect treatment progression. The blood test measures HER-2/NEU oncoprotein to help oncologists treat patients with metastatic breast cancer.

The CPT code, 83950, becomes effective Jan. 1, 2002, for most health insurance programs. Additionally, the Center for Medicaid and Medicare Services has proposed that the oncoprotein HER-2/NEU serum test be reimbursed at $89.01 starting in January 2002 for Medicare.

“Assignment of the CPT code is a significant step in recognizing that serum HER-2/NEU testing can be a cornerstone of metastatic breast cancer treatment management,” said Dr. Walter Carney, head of Bayer Diagnostic’s Oncogenic Science Group. “It is our hope that appropriate reimbursement with the CPT code will encourage clinical acceptance of serum HER-2/NEU testing, ultimately saving healthcare dollars through more streamlined clinical decision-making.

As a complement to conventional tissue testing such as IHC or FISH, which can determine a woman’s HER-2/NEU “status,” serum monitoring provides a “real time” picture of a woman’s HER-2/NEU levels, assisting oncologists in determining whether a particular therapy is having the desired effect on the disease.

Approximately 25 percent of breast cancers overexpress HER-2/NEU. These tumors tend to grow faster and are generally more likely to recur than those that do not overproduce the oncoprotein.

DiaSys patents disposable product for intestinal parasite specimen collection, processing
DiaSys Corp. announced the worldwide marketing launch of its new, disposable, product line for collecting and processing patient specimens for intestinal parasite analysis; a worldwide market estimated to be in excess of $65 million.

The Parasep product line is only one of several products acquired by DiaSys as a result of its acquisition of Intersep Ltd (private) a UK-based manufacturer of consumable laboratory products, supplies and kits.

“We have just received a U.S. patent for our Parasep technology from the U.S. Office of Patents and Trademarks,” said John R. Cordeiro, DiaSys director of marketing services.

“The unique and superior filtering qualities of our Parasep products enable hospital and clinical reference laboratory personnel to readily and more safely, filter ova and parasites from fecal specimens for analysis,” said Robert M. Felcher, DiaSys director of sales and service. The company is marketing its Parasep products as a stand-alone product line and also as part of a complete system with its FE-2 Series Automated Ova & Parasite Analysis Workstations.

DiaSys Corp. designs, develops, manufactures and distributes medical laboratory instrumentation, consumables reagents and test kits with applications in urinalysis, microbiology, electrophoresis, immunology and cytology.

Remel announces Allegiance will distribute its products
Lenexa, Kan.-based Remel, a manufacturer of clinical laboratory products, announced a new distribution agreement with Allegiance Healthcare Corp. of McGaw Park, Ill., a provider of healthcare products and cost management systems.

The agreement will provide Allegiance laboratory customers access to more than 6,000 Remel products for microbiology, immunology, parasitology, virology and serology. Remel has been serving the clinical and industrial laboratory market since 1973 and is now an Apogent Technologies company.

Remel’s portfolio includes: prepared and dehydrated culture media, infectious disease ELISA kits, serology and microbiology slide agglutinations, quality control organisms, susceptibility test, stains, collection and transport items and many other diagnostic testing materials. All products will continue to ship through Remel’s nationwide distribution network directly to customers.

“We believe the combination of our high-quality products and Allegiance’s extensive distribution services will provide greater flexibility to our current customers and increased access to new customers,” said Susanne Garay, Remel’s president.

Roche dismisses Delaware patent suit against Igen; Igen continues jury trial against Roche in Maryland
Igen Int., Inc. and F. Hoffmann-La Roche recently settled a patent infringement action brought by Roche against Igen in the U.S. District Court for the District of Delaware. The settlement follows Roche’s offer last month to resolve the Delaware Litigation. Trial in the Delaware Litigation was completed in February 2001 and the parties have been awaiting a ruling from the Delaware District Court. Under the settlement, Roche is dismissing all claims against Igen and is reimbursing Igen for the legal fees that it incurred in defending that suit, which total approximately $5.7 million.

Separately, Igen announced that it concluded its presentation to the jury in its multi-count lawsuit against Roche Diagnostics, a division of F. Hoffmann-La Roche, which commenced on Oct. 23, 2001 in the U.S. District Court for the District of Maryland. The Delaware Litigation settlement does not affect the continuation of the Maryland Litigation, in which Igen charges Roche with multiple breaches of a license agreement, violating its duty of good faith and fair dealing, and engaging in unfair competition. Over the past several weeks, the jury in the Maryland Litigation heard testimony from Igen’s senior executives, four expert witnesses, and Roche senior executives supporting Igen’s allegations in the case. Igen is seeking compensatory and punitive damages, termination of the license agreement and other relief. The Maryland Court had previously advised the jury that Roche’s offer to settle the Delaware Litigation would not prevent Igen from pursing its unfair competition claim against Roche in Maryland or from seeking damages.

Igen develops and markets biological detection systems based on its proprietary Origen technology, which is used in clinical diagnostics, pharmaceutical research and development, life science research and industrial testing for food safety and quality control. The systems are marketed by Igen and its licensees/ distributors — Roche Diagnostics, Organon Teknika, Eisai Co. Ltd., Sumitomo Corp. and Sanko Junyaku Co. Ltd.

Antibodies recognize one-atom differences in small molecules
Silver Lake Research Corp. has developed a proprietary antibody generation technology for small molecules (EAP – enhanced affinity platform).

This technology has been applied to consumer diagnostic products, assays for small molecule drug leads and clinical diagnostics. The company has developed the world’s only rapid immunoassay for single atoms.

Silver Lake is expanding application of EAP through partnerships with some of the world’s largest diagnostic, pharmaceutical and chemical companies in the development of OEM and customer test kits and immunoassay reagents.

Technology targeted for handheld bioagent detection system
Sunnyvale, Calif.-based Cepheid, a developer of integrated DNA testing systems, has granted Baltimore-based Environmental Technologies Group Inc. (ETG) a worldwide, non-exclusive sublicense to key patents for development of rapid, handheld DNA analysis systems for bioagent detection.

Under the agreement, Cepheid will receive royalties on ETG system sales and retains rights to commercialize the handheld systems for all other DNA-testing applications, including environmental testing and veterinary diagnostics. ETG obtains certain rights to patented component designs for performing and monitoring analytical reactions, such as the polymerase chain reaction (PCR) used in DNA detection, on a handheld device using battery power. Cepheid holds the exclusive license to these patents from the Regents of the University of California and Lawrence Livermore National Laboratories.

"Cepheid views this new agreement as a continuation of our partnership with ETG in the area of bioagent detection for both military and homeland security applications," said Tom Gutshall, chairman and CEO of Cepheid.

ETG is preparing to commercialize the Handheld Advanced Nucleic Acid Analyzer (HANAA), originally developed by LLNL. Weighing just two pounds, the HANAA is designed to rapidly test samples for the unique DNA sequences of bioagents or other pathogens following off-line sample preparation. Employing a method called real-time PCR, the device can simultaneously test up to six samples, each for two different DNA targets, and report results in as little as 15 minutes. Designed for military use and emergency response, the device is ideally suited for applications where speed and portability are critical.

"With this license from Cepheid, ETG will bring the first handheld, real-time PCR detection instrument to market," said Rick Thomas, president of ETG. "We are pleased to have Cepheid as a partner in delivering the power of DNA-detection technology to the civil defense first responders and others who must quickly detect and identify the presence of biological agents."

ETG is a provider of full-service, advanced engineering technology for nuclear, biological, and chemical detection systems for government and other commercial applications. Cepheid is a developer, manufacturer and marketer of miniaturized, fully integrated instrument systems for rapid, on-site detection of DNA.