Siemens Healthcare Diagnostics and Illumina have entered into a partnership aimed at setting new standards in the use of next-generation sequencing for the rapid, accurate identification of patients’ infectious disease states and potential treatment paths. Through this agreement, the companies plan to make existing Siemens molecular HIV tests compatible with the recently launched Illumina MiSeq next-generation sequencing platform, with the ultimate goal of introducing breakthrough sequencing-based infectious disease assays for the clinical diagnostics market.
Ten years ago the TRUGENE HIV-1 Genotyping Assay, the first DNA sequencing-based test for HIV to be cleared by the FDA, was launched to a worldwide market. This laid the foundation for Siemens to become a leader in infectious disease testing solutions that employ DNA sequencing technology. Since then, TRUGENE has become one of the market’s leading DNA sequencing tests for infectious disease testing. By making this test compatible with Illumina’s MiSeq analyser, Siemens expects to be well positioned to help even more clinical laboratories leverage next-generation sequencing for their infectious disease testing with the fastest turnaround time and highest accuracy possible.

Roche sets up co –marketing agreement with private laboratory to support greater access to HPV testing

In an innovative commercial agreement, leading healthcare company Roche and foremost private cellular pathology laboratory Unilabs-IHS, are collaborating to help make state-of-the art testing for signs of cervical cancer more accessible to thousands of women in London and throughout the UK.

Roche’s leading-edge and fully automated cobas® HPV test which runs on the acclaimed cobas 4800 system, will provide a fast turn-around of cervical smear samples from potentially thousands of women per year, sent to the London based laboratory from clinicians from all over the country.  The testing at Unilabs-IHS, will not only be conducted as a follow up  to the traditional “Pap” cervical smear method to check ambiguous results, it will also be used upon request in primary screening for cervical pre cancer, giving a greater chance to avoid disease progression.

The ultra-high reliability of the cobas HPV test will be of huge benefit for clinicians and patients alike, due to the test’s unique genotyping that individually identifies genotypes 16 and 18, the highest risk types associated with the development of cervical cancer and its precursor lesions, while simultaneously identifying 12 other high risk HPV types.  Such technology provides better risk stratification of patients enabling a more sensitive and efficient approach to cervical screening. 

Dr Glen Dixon,  Medical Director of Cytopathology at Unilabs-IHS   from Unilabs-IHS said “We are delighted to have come to this agreement with Roche.  Using the cobas HPV test on the cobas 4800 platform for our HPV testing work load, means that clinicians will not only have the fastest ever turnaround times, but will also have enhanced and incontrovertible HPV results, with no need to re-test – and all at no extra cost.”

Paul Eros, Director of Molecular Diagnostics at Roche said: “HPV testing provides earlier identification of those women at risk of developing cervical cancer.  The agreement that we have struck with Unilabs-IHS for cervical screening with the cobas HPV test, is a significant step forward towards spreading access to HPV testing at the primary screening stage.  Given the clear benefits of this technology to patients as well as the NHS, we look forward to seeing the technology’s timely introduction at the primary screening stage, across the country via the national cervical screening programme – promising a better deal for women and a more efficient approach to cervical screening.”

Researchers at Winship Cancer Institute have identified a new function for a gene that normally prevents the development of cancer.
Scientists had known that the gene, which encodes a protein called p14 ARF, works inside the cell to control proliferation and division. A team led by Erwin Van Meir, PhD, discovered that p14 ARF also regulates tumour-induced angiogenesis, the process by which growing cancers attract new blood vessels.
The findings provide insight into how cancers form and progress, communicate with surrounding vascular cells and could guide the development of new therapies to fight tumours whose growth is driven by loss of p14 ARF.
Van Meir is professor of neurosurgery and haematology & medical oncology at Emory University School of Medicine, and director of the Laboratory for Molecular Neuro-Oncology at Winship Cancer Institute. Abdessamad Zerrouqi, PhD, research associate, is the first author of the paper.
Pinning down the new function for p14 ARF was a several-year detective investigation for Zerrouqi. The gene was a slippery target because growing cells in culture tend to lose or silence it, he says. P14 ARF is not turned on in most tissues of the body, but is activated in response to aberrant growth signals.
The gene encoding p14 ARF is mutated or silenced in many types of cancers, including most gliomas, the most common brain cancer in adults. People who inherit mutations affecting this gene develop ‘melanoma-astrocytoma syndrome,’ with increased occurrence of both types of tumours. ARF stands for ‘alternate reading frame’ because the DNA sequence overlaps with another protein that is read out of step in comparison to ARF. Previous research had linked the function of p14 ARF to another gene, p53, which is also frequently mutated in cancers. P53 is known as ‘guardian of the genome’ because it shuts down cell division in response to DNA damage.
Zerrouqi says several clues pointed to a separate function for p14 ARF. P14 ARF is often lost when astrocytoma progresses to glioblastoma, a more deadly form of brain cancer.
‘These tumours are bigger, more infiltrative and more vascularised,’ he says. ‘Yet p53 is usually lost at an early stage, before this transition takes place. This suggested that p14 ARF has a function that is independent of p53.’
Zerrouqi could show that restoring p14 ARF in cells from a tumour that had lost it interfered with the tumour’s ability to stimulate blood vessel growth. P14 ARF induces brain cancer cells to secrete a protein called TIMP3, which inhibits vascular cell migration, he found.
Zerrouqi and Van Meir’s findings are applicable to brain cancers as well as several other cancer types. TIMP3 itself has been found to be silenced in brain, kidney, colon, breast and lung cancers, suggesting that it is an obstacle to their growth. Emory University School of Medicine

Scientists in the School of Health and Medicine at the University of Lancaster, UK, have developed a simple blood test for phosphorylated alpha-synuclein that detects Parkinson’s disease even at the earliest stages.
To develop the blood test, the researchers studied a group of people diagnosed with the disease and a second group of healthy people of a similar age. Blood samples from each group were analysed to determine the levels of phosphorylated alpha-synuclein present. They found those with Parkinson’s disease had increased levels. Based upon these findings, they developed a blood test that detects the presence of phosphorylated alpha-synuclein, which could allow for diagnosis of the disease well before symptoms appear but when brain damage has already begun to occur. This blood test could not only help rule out other possible causes of the outward symptoms which occur in Parkinson’s disease, but it could also allow early detection of the disease, which could help patients and their caregivers prepare for the possibility of the mental, emotional and behavioral problems that the disease can cause.

Using two cell surface markers found to be highly expressed in breast cancer lymph node metastases, researchers at Moffitt Cancer Center, working with colleagues at other institutions, have developed targeted, fluorescent molecular imaging probes that can non-invasively detect breast cancer lymph node metastases. The new procedure could spare breast cancer patients invasive and unreliable sentinel lymph node (SLN) biopsies and surgery-associated negative side effects.
‘The majority of breast cancer patients, up to 74 percent, who undergo SLN biopsy are found to be negative for axillary nodal, or ALN, metastases,’ said corresponding author David L. Morse, Ph.D., an associate member at Moffitt whose research areas include experimental therapeutics and diagnostic imaging. ‘Determining the presence or absence of ALN metastasis is critical to breast cancer staging and prognosis. Because of the unreliability of the SLN biopsy and its potential for adverse effects, a non-invasive, more accurate method to assess lymph node involvement is needed.’
The authors note that the postoperative complications to the SLN biopsy can include lymphedema, seroma formation, sensory nerve injury and limitations in patient range of motion. In addition, biopsies fail to identify disease in axillary lymph nodes in five to 10 percent of patients.
In developing targeted molecular probes to identify breast cancer in axillary lymph nodes, the research team from Moffitt, the University of Arizona and University of Florida used two surface cell markers – CAIX and CAXII. CAIX is a cell surface marker known to be ‘highly and broadly expressed in breast cancer lymph node metastases’ and absent in normal tissues.
CAIX and CAXII are both integral plasma membrane proteins with large extracellular components that are accessible for binding of targeted imaging probes, explained Morse. In addition, several studies have shown that CAIX expression is associated with negative prognosis and resistance to chemo and radiation therapy for breast cancer. CAXII is a protein expressed in over 75 percent of axillary lymph node metastases.
The researchers subsequently developed their targeting agents by using monoclonal antibodies specific for binding CAIX and CAXII, both of which are known to promote tumour growth.
According to the researchers, a number of non-invasive optical imaging procedures for SLN evaluation have been investigated, but the approaches have lacked the ability to target tumour metastasis biomarkers.
‘These methods provide only anatomic maps and do not detect tumour cells present in lymph nodes,’ explained Morse. ‘Using mouse models of breast cancer metastasis and a novel, monoclonal anti-body-based molecular imaging agents, we developed a targeted, non-invasive method to detect ALN metastasis using fluorescence imaging.’
In addition to the imaging study with mice, the researchers also reported that the combination of CAIX and CAXII covered 100 percent of patient-donated samples used in their tissue microarray (TMA) study. Moffitt Cancer Center