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In Vitro Diagnostic Technlogy Blog
 

Archive for June, 2009

Reitermann Appointed New Head of Siemens’ U.S. Organization

Tuesday, June 30th, 2009

Michael Reitermann has been appointed the new CEO of Siemens Healthcare’s U.S. organization, effective July 1, 2009. In his new position, Reitermann will lead the marketing, sales, and service functions for Siemens Healthcare in the United States, including the medical imaging, therapy, and healthcare information technology businesses. Reitermann succeeds Dr. Heinrich Kolem, who will assume the role of global head of Siemens Healthcare’s Angiography, Fluoroscopy, and X-ray business unit, based in Forchheim, Germany.

Reitermann has enjoyed a long career with Siemens. Among other things, he worked as a senior project manager at the corporate strategies division and a partner in Siemens Management Consulting. Reitermann also served as vice president for sales, marketing, and innovation of the Siemens Angiography, Fluoroscopy, and X-ray business unit. Most recently, as CEO of Siemens Molecular Imaging (MI) business unit, and president of the former Nuclear Medicine division since July 2002, Reitermann was responsible for the establishment and implementation of MI’s business objectives around the world.

Heinrich Kolem will take on a new challenge, assuming the role of global head of Siemens Healthcare’s Angiography, Fluoroscopy, and X-ray business unit. Since 2006, Kolem was the CEO of the Siemens Healthcare organization in the United States, overseeing launches of new imaging systems such as the Somatom Definition Flash, Magnetom Essenza, Biograph mCT, the Acuson S2000, and other innovations. Kolem started his Siemens career in the field of magnetic resonance imaging in 1989.

IVD Technology Presents a Special Report on Personalized Medicine

Monday, June 29th, 2009

The editors of IVD Technology are pleased to announce the release of a new special report, “DX Directions: Developing Companion Diagnostics for Personalized Medicine.” This special report carefully examines the critical issues regarding personalized medicine and the development of pharmacodiagnostics, which will significantly affect the IVD industry’s future. In a series of articles, this report provides a thorough and thoughtful analysis of these issues and discusses how they may be played out in the IVD industry. The report also makes recommendations as to the best course of action that the IVD industry should pursue to address these issues. By having the articles written by key industry figures, the report takes a personal approach that is closely identified with IVD manufacturers.

For more information about this special report, click here.

Students Win Competition for Handheld IVD Device

Thursday, June 25th, 2009

Two graduate students at Stanford University received the top prize in the first IEEE President’s Change the World Competition for designing and developing a handheld diagnostic device. They presented the NanoLab, a technology that will make it feasible to bring the same diagnostic potential of the developed world to third world countries or the patient’s home. More specifically, they designed a handheld device capable of quantitative multiplex protein detection in a very simple to use, wash-free assay that is more sensitive than the Enzyme Linked Immunosorbent Assay (ELISA). Due to the ease of use, portability, and low cost, their platform could have a very broad impact on society ranging from molecular diagnostics in remote villages in Africa (which lack laboratory equipment and skilled technicians) to over-the-counter home diagnostics kits that can be purchased at a local pharmacy.

In order to make the protein detection platform portable and easy to use, the students developed a new, innovative wash-free assay that requires only three simple steps by the end user. First, the end user places the sample into the reaction well. Second, a few drops of a solution containing magnetic nanoparticles is added. Finally, the detection antibody is introduced. Fifteen minutes after the detection antibody is added, the NanoLab test module will convert the concentration of protein detected into a colored light output. If the light is off, the protein is undetectable. A green light indicates low protein concentration, an orange light indicates medium protein concentration, and a red light indicates high protein concentration. Since the reaction well is equipped with 8 sensors, the device is capable of monitoring up to 8 different proteins simultaneously in a single assay.

Stanbio Obtains FDA Approval for POC Device

Wednesday, June 24th, 2009

Stanbio Laboratory, LP (Boerne, TX) received FDA approval of its HemoPoint H2 Hemoglobin Data Management System (DMS). The new, HemoPoint H2 DMS features the timesaving convenience, quality control, and recordkeeping ease of data management technology.

The new HemoPoint H2 DMS utilizes barcode identification of operators, patients, and control intervals, as well as, connectivity to PCs via Bluetooth. 4,000 patient and 500 QC results memory also contributes to an increased level of efficiency, while still including all the features of the original HemoPoint H2. The HemoPoint H2 DMS still includes both a hemoglobin and calculated hematocrit result with one simple test; a proprietary “soft load” cuvette holder designed to minimize contamination of the optics lens; and an easy-to-read backlit touch screen display.

LabCorp Acquires Monogram Biosciences

Tuesday, June 23rd, 2009

Laboratory Corporation of America Holdings (LabCorp) and Monogram Biosciences Inc. have entered into a definitive agreement and plan of merger under which LabCorp will acquire all of the outstanding shares of Monogram in a cash tender offer for $4.55 per share for an implied total equity value of approximately $106.7 million, or a total enterprise value of approximately $155 million at March 31, 2009, including net indebtedness.

Monogram’s proprietary, clinically validated Trofile assay identifies patients who are eligible for the CCR5 class of HIV drugs and is the widely adopted companion diagnostic for the HIV drug Selzentry. Monogram’s PhenoSense and PhenoSense GT HIV tests measure individual patient viral drug resistance, thereby enabling physicians to design optimal, individualized treatment plans for each patient. Monogram’s HIV tests are used routinely by physicians for managing patient therapy and are an integral component of anti-HIV drug development and clinical evaluations for the pharmaceutical industry.

Monogram’s proprietary VeraTag technology has been used to develop a sensitive means to assess HER-2 status in tissue samples and has significant potential as a tool to help guide therapy decisions in breast cancer patients. Based on the VeraTag platform, Monogram has multiple tests in development for measuring a variety of protein markers that may have clinical utility to help guide treatment decisions across a broad range of cancer drugs. The potential oncology pipeline associated with this technology is a natural extension of LabCorp’s existing oncology offerings for both clinical trials and commercial clients.

Under the terms of the agreement and plan of merger, LabCorp’s acquisition subsidiary, Mastiff Acquisition Corp., will commence a tender offer to purchase all outstanding shares of Monogram Biosciences for $4.55 per share in cash, without interest. Following the completion of the tender offer, LabCorp expects to merge Mastiff Acquisition Corp. and Monogram resulting in any shares not purchased in the tender offer being converted into the right to receive the same cash price per share as paid in the tender offer. The closing of the acquisition is expected in the third quarter of 2009.

Vivacta Closes $4.5 Million Financing

Thursday, June 18th, 2009

Vivacta Ltd. (Sittingbourne, Kent, UK) announced that following development of its TSH (thyroid function) test, together with prototype commercial readers, it has closed a $4.5 million financing round that was fully subscribed by existing investors. Neil Butler, Vivacta’s CEO commented, “The success of this financing round underpins the support we have from our shareholders and signals their confidence that our ultrasensitive immunochemistry platform will reset the benchmark for diagnosis at the point-of-care. The clinical evaluation of the system has now commenced, and we anticipate achieving regulatory clearance within 12 months. The cartridge pilot manufacturing facility has commenced weekly manufacturing campaigns for internal evaluation. Validation of the facility and product is planned for later this year.”

Further announcements regarding commercialization of the system are anticipated in the coming months. Vivacta’s current investors include AGF Private Equity, HBM Bioventures, Spark Ventures and the original sponsor Viking Technologies. For more information about Vivacta and its technology, click here.

Great Basin Scientific Completes $3.6 Million Funding

Wednesday, June 17th, 2009

Great Basin Scientific Inc. (Salt Lake City), a privately held life sciences company developing point-of-care molecular diagnostic solutions, closed $3.6 million in bridge funding to support the company through 2009 and the launch of its first product, pending FDA 510(k) clearance in December. Returning investors participated in the funding round.

As part of the preparation for an August clinical trial for its first test, a 50 minute diagnostic test for methicillin resistant staphylococcus aureus (MRSA) from a positive blood culture, Great Basin Scientific is leading several preclinical studies. The company conducted a feasibility study last spring as it characterized 132 retrospective samples from study collaborators at Children’s Memorial Hospital in Chicago and Denver Health Hospital. Testing was performed at Great Basin Scientific’s lab in Longmont, CO.

Beginning as early as mid-July, several major hospitals will serve as beta-testing sites for Great Basin Scientific’s point-of-care molecular platform. During beta-testing, clinicians will test the analyzers and provide feedback on process flow and functionality. The testing will serve as preparation for the clinical trials scheduled to begin in August. In addition to its first product for MRSA testing, the company is also developing tests for group B streptococcus and human papillomavirus (HPV).

New Data Presents Potential for Alzheimer’s Diagnostic

Tuesday, June 16th, 2009

Data published in the June issue of the Journal of Alzheimer’s Disease demonstrated that minimally-invasive biospectroscopy was able to identify changes in oxidative stress levels in blood plasma, which may prove to be a useful biomarker in the early detection of Alzheimer’s disease. There is currently no accepted laboratory test for diagnosing Alzheimer’s disease.

Researchers at McGill University and the Lady Davis Institute for Medical Research at the Jewish General Hospital (Montreal) have shown that near-infrared (NIR) biospectroscopy can identify a biomarker in blood that distinguishes Alzheimer’s disease from normal aging and possibly other neurodegenerative conditions. Diagnosis of Alzheimer’s disease is currently based solely on a patient’s medical history and neurological examination, is labor-intensive and expensive, and often inconclusive in early stages of the illness. The availability of a biologic marker that reliably differentiates Alzheimer’s disease from normal aging and other dementing conditions would represent a major achievement in the management of this common neurodegenerative disorder.

In this study, an NIR biospectroscopy analysis was conducted on blood plasma samples from a total of 63 subjects, 19 with Alzheimer’s disease, 27 with mild cognitive impairment (a frequent indication of Alzheimer’s disease), and 17 normal elderly controls, to measure the degree of oxidative stress in plasma. Oxidative stress is caused by a chemical imbalance that can damage critical components of cells and biofluids, including proteins, lipids and DNA. Oxidative stress is known to be involved in many neurological diseases, including Alzheimer’s and Parkinson’s disease. 

In differentiating Alzheimer’s disease patients from the normal elderly control group, NIR achieved a sensitivity of 80% and specificity of 77%. Fifteen and twelve patients with mild cognitive impairment were classified with the normal elderly control group and Alzheimer’s disease groups, respectively.

Bill Proposes Improving Access to Critical Tests

Thursday, June 11th, 2009

U.S. Senators Arlen Specter (PA) and Ron Wyden (OR) introduced legislation that will improve access to life-saving diagnostic tests for patients who might otherwise be denied. The Patient Access to Critical Lab Tests Act (S. 1220) will eliminate the complicated Medicare billing regulations which discourage hospitals from ordering revolutionary laboratory tests needed to clarify complicated diagnoses and identify uniquely effective methods of treatment. This bill serves as a companion to HR 1699, introduced by U.S. Congressman Jason Altmire (PA-04), and cosponsored by U.S. Representatives Tim Murphy (PA-18), Mike Doyle (PA-14), Anna Eshoo (CA-14), and Lucille Roybal-Allard (CA-34).

The Patient Access to Critical Lab Tests Act dramatically improves patients’ access to potentially life-saving lab tests by allowing independent laboratories to directly bill Medicare for the specialized tests they perform. By streamlining the reimbursement process, doctors will no longer be discouraged to utilize their judgment and order the necessary tests capable of improving the quality of treatment for their patients.

Current Medicare regulations thwart access to these important tests and discourage innovation by requiring hospitals to act as middlemen in the billing process. Laboratories are required to bill hospitals, and hospitals are required to bill Medicare. The Patient Access to Critical Lab Tests Act would permit independent laboratories that develop and perform certain qualifying genetic, genomic or proteomic tests and cancer chemosensitivity assays to bill Medicare directly.

Cepheid Obtains NIAID Grant

Wednesday, June 10th, 2009

Cepheid (Sunnyvale, CA) received a notice of grant award from the National Institute of Allergy and Infectious Diseases to develop new ten-color detection technology for use in its GeneXpert System. The $7.5 million grant will be awarded to Cepheid and the University of Medicine and Dentistry of New Jersey during the planned five-year program. When coupled with Cepheid’s virtual array technology, the new ten-color system will have the potential to simultaneously detect up to 100 different targets per sample. Cepheid’s current GeneXpert System is capable of six-color detection, with the potential for up to 60 different targets per sample.

The new ten-color technology is expected to deliver more cost-effective infectious disease panel testing applications by increasing the total number of diagnostic results per sample. The technology will also enable the development of new, comprehensive antimicrobial resistance and oncology tests.

Building upon the success of Cepheid’s six-color Xpert MTB/RIF test, clinical utility of the ten-color system will be demonstrated through the development of a new assay for multidrug-resistant and extensively drug-resistant Mycobacterium tuberculosis. Future GeneXpert-based tests, which apply the ten-color technology, are expected to follow.