EKF Diagnostics has entered a multi-year, collaborative relationship with Joslin Diabetes Center (“Joslin”) in support of the ongoing clinical and commercial translation of TNFR1 & 2 biomarkers. These novel biomarkers can help identify patients with Type 1 and Type 2 diabetes that are at an increased risk of developing end stage renal disease (ESRD), up to ten years in advance. The new agreement between Joslin, an affiliate of Harvard Medical School, and EKF is part of Joslin’s Corporate Liaison Program (CLP). This programme seeks to accelerate development, validation and market introduction of unique products and solutions that advance treatments and care for diabetes and its complications. As globally recognized leaders in the field of diabetes research, Joslin has created the CLP in order to foster industry partnerships within the pharmaceutical, biotechnology, food and device industries. The role of the CLP is to help engage corporate partners, such as EKF, with Joslin’s capabilities in advisory services, clinical expertise, and research infrastructure.  This enables Joslin to work closely with an industry partner to customize its offerings towards a defined product programme or a range of corporate priorities within diabetes management. EKF will access certain clinical and research expertise at Joslin under the CLP to further develop its TNFR biomarker test. The two key objectives of this effort are to (a) accelerate the clinical development, as well as understanding physician adoption criteria and trends relating to the TNFR-1/2 test; (b) advance the research to support the clinical utility of TNFR 1&2 assays as biomarkers in diabetic kidney disease. This will be accomplished in part by leveraging the collaboration of Joslin with certain partners in the pharmaceutical industry.

Finding out whether you have been infected with dengue may soon be as easy as spitting into a rapid test kit. The Institute of Bioengineering and Nanotechnology (IBN) of A*STAR has developed a paper-based disposable device that will allow dengue-specific antibodies to be detected easily from saliva within 20 minutes. This device is currently undergoing further development for commercialization.

IBN Executive Director Professor Jackie Y. Ying shared, “Our rapid diagnostic kit can detect a key dengue antibody from saliva that is present in early-stage secondary infection. The ability to differentiate between primary and secondary dengue infections makes it a valuable early diagnosis tool that would help to ensure timely treatment and proper care of patients.”

Patients with secondary infection, who have previously been infected with other serotypes of dengue virus, stand a higher risk of developing dengue haemorrhagic fever or dengue shock syndrome.

According to Singapore’s National Environment Agency, dengue fever and its more severe form, dengue haemorrhagic fever, are the most common mosquito-borne viral diseases in the world. This disease poses a serious health threat, and is a leading cause of illness and death in tropical and subtropical climates. There are four known serotypes of the dengue virus, but no vaccine or medicine has been developed to treat the illness. The incubation period before symptoms develop generally ranges from 4 to 10 days after infection. Therefore, early diagnosis would enable the patient to receive prompt medical attention and avoid further complications.

Currently, dengue infection is diagnosed in the laboratory by testing the patient’s blood sample for the presence of dengue antigens or antibodies. IBN’s device, on the other hand, is capable of detecting IgG, a dengue-specific antibody found at the onset of secondary infections, directly from saliva in one step.

Unlike blood samples, saliva can be collected easily and painlessly for rapid point-of-care diagnostics. However, unlike other body fluids, it cannot be applied directly to commercially available test kits as it would cause the sensor nanoparticles to stick haphazardly to the test strip. In addition, conventional paper-based tests are not designed to handle the larger sample volume of saliva required.

As described in the journal Lab on a Chip, the IBN researchers used an innovative stacking flow design to overcome key challenges faced by existing lateral flow designs, such as those used in pregnancy test kits.

In IBN’s device, different flow paths are created for samples and reagents through a multiple stacked system. This allows the saliva sample to flow separately through a fibre glass matrix, which removes the substances that would interfere with the nanoparticle-based sensing system before it mixes with the sensor nanoparticles. IBN’s device configuration also helps to regulate the flow in the test strip, generating uniform test lines for more accurate results.

By simplifying the diagnostic procedure, the researchers hope to make the device as easy to use as over-the-counter pregnancy or fertility test kits. IBN’s oral test kit may be adapted to detect other infectious diseases. The IBN researchers are also investigating the use of other common fluid samples, such as blood, urine and serum for rapid, high-sensitivity test kits.

The Institute is currently collaborating with ARKRAY Inc., a pioneer in the field of automated analysis systems, to commercialize its paper-based diagnostic technology. In 2013, ARKRAY opened its first Asian research center outside Japan in IBN with an investment of S$9.1 million over five years. The research center is focused on developing novel detection kits for infectious diseases based on IBN’s innovative diagnostic platforms. Agency for Science, Technology and Research (A*STAR)

An international team of researchers led by KU Leuven has developed a new test to help doctors diagnose ovarian tumours and choose the most appropriate treatment. The researchers have recently described the test called ADNEX `

Existing predication models for ovarian cancer discriminate between benign and malignant tumours but lack accuracy and are unable to sub-classify different types of malignant tumour. This makes determining the appropriate treatment difficult, since some ovarian tumours require more serious treatment than others.

The new test developed by Professor Ben Van Calster (KU Leuven) in cooperation with the International Ovarian Tumour Analysis group (IOTA) not only discriminates between benign and malignant tumours but also makes it possible to accurately identify and classify malignant tumours into four types: borderline, stage 1 invasive, stage II-IV invasive and secondary metastatic.

The test is based on the patient’s clinical information, a simple tumour marker blood test and features that can be identified on an ultrasound scan. In addition to identifying the type of tumour, the test also expresses the confidence of the diagnosis as a percentage.

Doctors can use the test in a clinical database or by entering the patient’s details into a smartphone app, which was demonstrated to gynaecologists at the International Society for Ultrasound in Obstetrics and Gynecology World Congress in Barcelona last month. The authors of the study say doctors could start using ADNEX straight away.

Successful treatment depends in large part on the correct identification of the type of tumour, but this can be difficult. As a result, many women with ovarian cancer are not referred to the right specialist and some undergo more serious operations than necessary. A benign ovarian tumour often does not even need treatment at all.

But for malignant tumours especially, determining the tumour type is crucial to selecting the right specialist surgeon and treatment.

The researchers developed the test using data from almost 6,000 ovarian cancer patients, which were gathered and analysed by the IOTA group led by Professor Dirk Timmerman of UZ Leuven (University Hospitals Leuven), KU Leuven’s network of research hospitals. University of Leuven

Partnering with head and neck surgeons, pathologists at Dartmouth Hitchcock Medical Center’s Norris Cotton Cancer Center developed a new use for an old test to determine if a patient’s cancer is recurring, or if the biopsy shows benign inflammation of mucosal tissues. Lead author Candice C. Black, DO explains how her team confirmed the utility of ProExC, an existing antibody cocktail commonly used for pathology tests of the uterine cervix. The team’s goal remained sorting out problems presented by the frequently equivocal pathology results when surgeons need to determine the difference between true pre-neoplasia and merely inflammatory/reactive biopsies.

‘In reality, the biopsies we receive from head and neck patients are often tiny and poorly oriented. Particularly in smokers and other post-treatment patients, inflammation may cause reactive epithelial atypia that is difficult to distinguish from dysplasia,’ reported Dr. Black. ‘This new use of the ProExC antibody cocktail allows us to provide the head and neck surgeons with key information about which patients have post-therapy complications versus those with true tumour recurrence.’

The World Health Organization (WHO) provides two systems for classifying dysplasia, and both have been criticized as being too subjective and failing to predict disease progression. A spectrum of histologic aberrations in mucosal membranes can mimic dysplasia, as well as neo-plastic cytologic and architectural changes. This is the first attempt to use ProExC as a diagnostic adjunct in the detection of head and neck mucosal biopsies.

Pathologists used 64 biopsies from the Dartmouth archives to setup groups of patients who had and had not progressed to cancer, and found statistically significant differences between the progression cases and the controls in terms of the stain scores using ProExC. ‘The surgeons wanted to know if the mucosa was neoplastic or just inflamed and reactive. The old-school answer of ‘atypia’ simply isn’t sufficient to make decisions about therapeutic interventions,’ described Black. Norris Cotton Cancer Center at Dartmouth-Hitchcock

A novel study by the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS) found that an increase in a gene known as Leo1 affects other genes that are directly implicated in acute myelogenous leukaemia (AML), increasing the incidence of cancer.

Led by Associate Professor Chng Wee Joo, Deputy Director and Senior Principal Investigator at CSI Singapore and Director of the National University Cancer Institute, Singapore, the scientists discovered that inhibition of Leo1 and Leo1 downstream signalling pathways provide an avenue for targeted treatment of AML.

In addition, this is the first study to suggest that the protein PRL-3 plays a role in the regulation of ribonucleic acid (RNA) related processes, a finding which advances the understanding of how the protein contributes to cancer progression. The team’s work represents the first large-scale quantitative survey of proteins regulated by PRL-3 in leukaemia.

The elevated expression of PRL-3 has been implicated in the progression and metastasis of an array of cancer types, including gastric, ovarian, cervical, lung, liver, and breast. In particular, the protein PRL-3 is overexpressed in about half of AML patients and associated with poor survival. Assoc Prof Chng and his team were the first to report that elevated PRL-3 protein expression occurs in about 47 per cent of AML cases while being absent from normal myeloid cells in bone marrow. As a result, PRL-3 is deemed as an attractive therapeutic target that spares normal tissues.

Previously, knowledge of the mechanisms of PRL-3 was limited. In this study, the researchers used a new, advanced SILAC-based mass spectrometry to identify all the protein changes induced by PRL-3 in a comprehensive manner. Using this approach, they discovered that the gene Leo1 serves as a novel target of PRL-3 phosphatase, and inhibition of Leo1 as well as Leo1 downstream signalling pathways provide an avenue for PRL-3 targeted therapy for AML patients.

In the next phase of research, the team is validating several important proteins directly downstream of Leo1 that can possibly be used as biomarkers and drug targets to improve treatment for leukaemia with PRL-3 overexpression.

Assoc Prof Chng said, ‘Our previous studies showed that PRL-3 is clinical and biologically important in acute myelogenous leukaemia, and may therefore be a useful treatment target. In the current study, we have taken the work further by understanding how PRL-3 confers cancer properties to the leukaemia cells. This now provides a framework for rational design of a treatment based on mechanistic understanding. In the process, we will also develop biomarkers to better select patients for the treatment and hence, progress towards personalising treatment for leukaemia patients.’ EurekAlert