A Diagnostics & Imaging Week

St. Jude Medical (St. Paul, Minnesota) reported receipt of CE mark approval for its AnalyST implantable cardioverter defibrillator (ICD) with ST Monitoring, calling it "a revolutionary device that not only provides life-saving therapy for dangerously fast heart rhythms, but also continuously monitors electrical changes between heartbeats (called ST segments) to help physicians monitor disease progression."

The company said this new monitoring capability may give physicians earlier and more accurate insight into cardiac problems and may help reduce patient risks.

The device was introduced this week at the International Symposium on Progress in Clinical Pacing, held in Rome.

The company said AnalyST ICD with ST Monitoring is the industry's first device to continuously monitor specific changes in the heart's electrical system which can indicate conditions such as ischemia. It noted that changes in the ST segment also have been linked to events such as heart attacks.

"Learning about these conditions earlier may lead to more timely diagnosis and therapy for patients, and possibly improve patient prognosis," St. Jude said in a statement.

"The AnalyST ICD is the only implantable device that can provide me with ST segment monitoring reports via high-quality, intracardiac electrograms, as well as additional ST segment diagnostic reports," said Christian Hamm, PhD, of the Kerckhoff Klinik (Bad Nauheim, Germany), who implanted the first AnalyST ICD. "This device provides me with new and valuable information about my patients' ST segments that is otherwise not available and helps me deliver better and more timely care for my patients with arrhythmias and coronary artery disease."

With the device's monitoring diagnostic, small changes in ST segment are "continuously and precisely recorded and plotted," St. Jude said, and then retrieved for the physician to review during patient follow-up visits.

It noted that because many cardiac episodes are transient in nature, continuous ST monitoring is important because it gives physicians more comprehensive ST segment information over time rather than a sporadic, hit-or-miss diagnostic report.

The company added that in the near future, physicians also will be able to monitor patients' ST segment changes via remote transmissions from the St. Jude Medical Merlin@home transmitter, a wireless remote monitoring system in patients' homes, and will receive alerts through the Merlin.net patient care network.

Eric Fain, MD, president of St. Jude's Cardiac Rhythm Management Division, said, "Unlike a diagnostic surface ECG, the AnalyST ICD continuously monitors and reports ST-segment changes over time while the patient goes about their normal daily activities."

Two new test kits from China Medical

China Medical Technologies (Beijing) said it has completed the development of two molecular diagnostic kits for the detection of epidermal growth factor receptor (EGFR) abnormalities in patients with non-small cell lung cancer (NSCLC). The company said it expects to offer the kits to its hospital customers through its direct sales force in January.

Iressa and Tarceva are commonly used drugs for the treatment of patients with NSCLC. According to publications in medical journals, EGFR abnormalities have been found in about 85% of NSCLC patients responsive to Iressa and Tarceva. Some of these abnormalities could be identified by using FISH-based technique to detect increase in gene copy numbers; others could be detected by using real-time PCR-based technique to analyze EGFR gene mutations.

The company said it has developed both FISH and real-time PCR-based molecular diagnostic kits for detecting EGFR abnormalities. The test result provides guidance for physicians to determine the most appropriate therapy for patients with NSCLC.

Lung cancer is one of the most common cancers in the world and is the leading cause of cancer death in China. It is estimated that more than 500,000 new lung cancer cases are diagnosed each year in that country.

CE mark for VYOO sepsis test

SIRS-Lab (Jena, Germany) reported that European Union regulatory authorities have granted the CE mark for VYOO, a molecular diagnostic test for pathogen detection in sepsis. With VYOO, clinicians can rapidly and reliably identify causative pathogens as well as important antibiotic resistance markers. Therefore VYOO allows for a customized anti-infective therapy in each patient within the critical hours of treatment.

SIRS-Lab said receipt of the CE mark will accelerate the implementation of VYOO into clinical routine throughout Europe.

Sepsis, a life-threatening systemic infection, occurs in more than 2 million cases per year and is the second-ranked cause of death in hospitals after cardiovascular diseases.

SIRS-Lab, a leading molecular diagnostic company in the field of sepsis, has released VYOO in 2007. It said the cutting-edge pathogen detection test provides "significant advantages" over currently used methods in clinical practice.

Partnership on imaging in UK

Acrobot (London), which specializes in computer-assisted orthopedic surgical navigation, and Alliance Medical (also London), part of the largest pan-European medical imaging company in Europe, supporting more than 400 hospitals and clinics in the UK, reported that they have entered into a partnership which will help improve surgical outcomes through the provision of advanced imaging techniques.

The deal will see Acrobot and Alliance Medical collaborate to provide orthopedic surgeons with an integrated process from CT scanning through to navigated joint replacement that can influence clinical outcomes.

The companies said the availability of such a process "makes life easier for the surgeon and better for the patient."

Alliance operates CT scanners in central London via its Alliance Medical Imaging Centres London division. These produce data using Acrobot's Modeller software, allowing Alliance to create 3-D models of patients' anatomy – the essential building block of the process.

Once the 3-D model is created, surgeons have the option to create "Patient Plans" on an ordinary laptop or desktop PC. "These plans can be used to provide detailed component sizing and position using Acrobot's Planner software and, if desired, the surgeon can take this plan into theatre and reproduce it accurately and reliably using Acrobot Navigator."

The agreement will enable more surgeons to access Acrobot's Navigator system: technology that is now usable in a wider range of procedures including uni-condylar knee and total hip replacements. This distribution arrangement is Acrobot's first commercial route-to-market agreement using Modeller.

Partec cites gains with CyFlow

Partec (Garlitz, Germany) is expanding its global leadership in specialized HIV monitoring and AIDS patient follow-up diagnostics for developing and emerging countries.

In 2008, 2.5 million patient tests have been performed with the portable, robust and affordable CyFlow system, already supporting more than 1 million people living with HIV/AIDS.

With the introduction of the Partec innovation, the company said the average cost of €160 per patient per year could be reduced to just €8.

CyFlow instruments are being successfully used in nearly all sub-Saharan African countries, and the technique is being applied in Asia, Latin America, Europe and the U.S.

This month, the thousandth CyFlow device will be placed since introduction at the XVI. International AIDS Conference in Barcelona in July 2002.

By precisely measuring the CD4 T-lymphocyte concentration from blood samples, the CyFlow delivers accurate information about the immune status level of HIV/AIDS patients. This test is required as a basis for antiretroviral therapy targeting in order to stabilize the immune status which is essential for survival.

Some 33 million people worldwide are living with HIV/AIDS, with more than 95% of them residing in developing countries, especially in Africa and Asia.