Siemens Healthcare Diagnostics has partnered with two pharmaceutical companies, ViiV Healthcare and Tocagen, to develop diagnostic tests alongside targeted drugs for HIV and cerebral cancer.

As ViiV Healthcare is a joint venture of Pfizer and GSK focused on HIV treatment, the partnership represents a collaboration of leading pharma and medtech companies.

It also signals major company investment in ‘stratified medicine’, where drugs targeting narrow patient groups are developed alongside ‘companion diagnostics’ to identify suitable patients.

Siemens CEO Michael Reitermann said the new projects would “align Siemens with new classes of therapies tailored to the individual”.

ViiV Healthcare will partner with Siemens for clinical trials of its first-in-class CCR5 co-receptor antagonist Celsentri (maraviroc) and investigate the commercial prospects of a diagnostic test to assist in patient selection.

Celsentri was licensed in 2007 in Europe and the US as a treatment for CCR5-tropic HIV. It is currently in a phase III study to establish its efficacy in combination with darunavir/ritonavir.

The planned trials will put the combination head-to-head with the combination of Gilead’s Truvada and darunavir/ritonavir.

US company Tocagen will partner with Siemens to produce diagnostic tests to support clinical trials of Tocagen’s viral gene therapy Toca in two forms, injectable Toca 511 and extended-release Toca FC tablets, in treating primary brain cancer.

For diagnostics companies such as Siemens, gaining access to the companion diagnostics market – which is already worth $1.5bn – depends on collaboration with pharma companies.

A new point-of-care analyser for blood gases and other solutes, launched worldwide, promises quicker and easier diagnosis in the critical care environment.

The RAPIDPoint 500 Blood Gas System (pictured) from Siemens Healthcare Diagnostics delivers reliable results in 60 seconds and allows rapid identification of the patient and operator.

The new system aims to meet the growing demand for POC blood tests that can be used rapidly and easily by a wide range of clinicians.

The RAPIDPoint 500 analyser has a cartridge that lasts up to 28 days, with a full complement of critical-care tests for blood gases, pH, electrolytes, glucose and lactate-1, as well as full CO-oximetry, from a single whole-blood sample.

Features to enhance ease of use include:

• fully automated calibration and quality control
• a self-contained Automatic Quality Control cartridge that operates without manual intervention
• an integrated bar code reader with a wide scanning area for patient and operator identification.

The new medical device can be integrated with the Siemens RAPIDComm Data Management System to enable centralised management of multiple Siemens blood and urine analysers in critical care monitoring.

“The RAPIDPoint 500 system is designed to satisfy the unique demands of testing at the point of care,” said Dr. David Stein, CEO, Point of Care Business Unit, Siemens Healthcare Diagnostics.

“In addition to being easy to use, the analyser leverages proven and reliable cartridge-based technologies to deliver fast, accurate, laboratory-quality results, helping clinicians feel confident in making critical decisions.”

A new syphilis assay launched in the UK adds to the armoury of healthcare providers to combat rising levels of sexually-transmitted diseases.

The fully-automated ADVIA Centaur Syphilis 1 assay from Siemens Healthcare Diagnostics has CE Mark approval for use on Siemens’ ADVIA Centaur family of immunoassay systems.

This addition to the ADVIA Centaur menu enables hospitals to further consolidate their testing for infectious diseases onto a single platform.

The new assay detects antibodies against Treponema pallidum, the bacterium known to cause syphilis. Because the symptoms of syphilis are rarely distinctive, it often goes undiagnosed until it has caused serious harm such as neurological damage or stillbirth. A specific test can support treatment with antibiotics as well as disease control measures.

A recent overview of 10 studies involving 41,000 women established that screening and treatment of syphilis in pregnant women could reduce the frequency of stillbirths and perinatal deaths due to the disease by half.

The portfolio of automated infectious disease assays available from Siemens Healthcare Diagnostics allows the integration of testing across a range of diseases, saving time for clinicians and patients.

Dave Hickey, CEO of the Chemistry, Immunoassay, Automation and Diagnostics IT Business Unit at Siemens Healthcare Diagnostics, said: “Consolidating syphilis testing onto a single system addresses a critical challenge of laboratories today – to improve operational efficiency while delivering fast, accurate results that help guide clinicians in identifying and caring for patients affected by this disease.”

Siemens Healthcare Diagnostics has launched a 60-minute blood test for the early detection of liver damage.

The ELF test is the first automated liver fibrosis test leading to the diagnosis of Chronic Liver Disease through the use of a standardised direct biomarker panel.

William Rosenberg, MBBS, D. Phil, Peter Scheuer Chair in Liver Diseases and Joint Director of the Centre for Hepatology at University College London stated that the test is beneficial because “clinicians are able to intervene before significant damage to the liver occurs.”

The traditional detection process of assessing liver fibrosis has been trans-abdominal needle biopsy of the liver. The procedure can be painful, with bleeding occurring in approximately one in 1000 cases and death in one in 10,000 cases.

Dave Hickey, CEO of Chemistry, Immunoassay, Automation, and Diagnostics IT Business Unit at Siemens Healthcare Diagnostics, commented: “By offering an automated, routine, minimally invasive blood test, Siemens provides an additional tool to physicians to aid them to easily assess the severity of liver fibrosis in their patients with chronic liver disease.”

The use of a blood test to identify those with significant liver disease will greatly aid triage and the appropriate targeting of interventions including weight loss, exercise, and therapeutic interventions.

Liver fibrosis refers to the accumulation of tough scar tissue in the liver. The formation of this tissue is a normal bodily response to injury or disease, but in fibrosis this healing process goes awry. Over time, the fibrosis may become severe, leading to cirrhosis that may require a liver transplant or result in death.

A new blood test for liver scarring or fibrosis, a leading indicator of chronic liver disease, can deliver results within an hour.

The Enhanced Liver Fibrosis (ELF) test from Siemens Healthcare Diagnostics is the first automated, standardised blood test for liver fibrosis, offering clinicians a quick and reliable option.

The new test has gained CE Mark approval for use on the Siemens ADVIA Centaur Immunoassay Systems.

Siemens is the only company to offer an integrated portfolio of diagnostic solutions for managing liver health.

The ELF test combines three direct serum biomarkers in a single ELF score, which correlates to the level of liver fibrosis assessed by biopsy. A 7-year study involving over 450 patients has shown that the ELF markers are comparable to liver histology at predicting clinical outcomes of CLD.

Liver fibrosis represents the liver’s response to injury or disease. Chronic liver diseases such as cirrhosis and liver cancer are among the top 10 causes of death worldwide.

“The discovery of the ELF markers represents a significant advance in the diagnosis of patients with liver disease,” stated William Rosenberg, Joint Director of the Centre for Hepatology, University College London. “Of particular benefit, the ELF test can help to identify patients with mild-to-moderate liver fibrosis, which is usually asymptomatic, so that clinicians are able to intervene before significant damage to the liver occurs.”

Dave Hickey, CEO of Chemistry, Immunoassay, Automation and Diagnostics IT at Siemens Healthcare Diagnostics, explained that liver biopsy can cause patient discomfort and take time to interpret. “By offering an automated, routine, minimally-invasive blood test,” he said, “Siemens provides an additional tool to physicians to aid them to easily assess the severity of liver fibrosis in their patients with chronic liver disease.”

 
Siemens ELF test