Transgene to collaborate with the EORTC on a Phase 2b Trial with TG4001 in head and neck cancer

Transgene SA is to collaborate with the European Organization for Research and Treatment of Cancer (EORTC) for the conduct of a randomized phase 2b study of TG4001 in patients with HPV16 positive Oropharyngeal Squamous Cell Carcinomas (OSCCs).

The study will be a multinational, placebo controlled, randomized, phase 2b trial led by the EORTC in which TG4001 will be administered in combination with chemo-radiotherapy in patients with HPV16 positive OSCCs whose tumor is locally advanced (non-metastatic). The main objective of the study will be to show a reduction in the relapse rate in patients receiving TG4001 in addition to this standard of care. Approximately 200 patients should be enrolled.

New liquid ready-to-use Tumour Marker Control available now from Randox

The new Randox Acusera multi-analyte Liquid Tumour Marker Control covers a total of 15 commonly tested and esoteric cancer antigens and tumour markers. The inclusion of assayed, instrument specific target values enables laboratories to effectively monitor both accuracy and precision. 

The Liquid Tumour Marker Control includes AFP (Alpha-fetoprotein), Beta-2- Microglobulin, CA15-3, CA19-9, CA27-29, CA72-4, CA125, CEA (Carcinoembryonic Antigen), Cyfra 21-1, Ferritin, hCG (Human Chorionic Gonadotropin), NSE (Neuron-specific Enolase), PSA Free (Prostate Specific Antigen Free), PSA Total (Prostate Specific Antigen Total) and Thyroglobulin. 

The liquid ready-to-use format is highly convenient for laboratory staff to use requiring no preparation. Furthermore the material can be easily shipped and stored at +2-8oC. Liquid stable controls not only eliminate the need for reconstitution but reduce the amount of human handling necessary. The user friendly 6 x 3ml pack size and open vial stability of 30 days at +2-8oC for all analytes listed significantly helps to minimise waste and keep running costs low.

Mundipharma strengthens oncology portfolio with strategic collaboration for next generation alkylating agents

Mundipharma International Corporation Limited and Northlake International LLC have announced that they have entered into a strategic collaboration agreement to develop structurally novel – next generation alkylating agents for the treatment of haematological malignancies. 

The agreement grants Mundipharma and its independent associated companies worldwide intellectual property rights, excluding China, to Northlake International’s lead product NL-101 as well as its pipeline of back-up molecules. NL-101 is a novel fusion molecule developed through Northlake International’s Dual Functional Cytotoxic Targeted Therapy (DCTT) technology. This new chemical entity has a bendamustine back-bone plus a histone deacetylase (HDAC) pharmacophore, providing a dual specificity therapeutic small molecule capable of targeting both a 'conventional' cytotoxic pathway and a 'modern' molecular targeted pathway with a single molecule.

Winners for 2012 Scrip Awards

London’s Lancaster Hotel saw industry achievements across the board being celebrated last night at a glittering ceremony for the 8th Annual Scrip Awards.

The ceremony, hosted by the journalist and broadcaster John Sergeant, rewarded excellence over the whole range of industry activities, from pharma, biotech and those companies that support them. Despite 2012 being remarkable for the patent cliff, the Euro crisis and yet more damage to pharma’s reputation in the mainstream media, there was still much to celebrate in your achievements.

Assay provides fluorescence polarization-based detection to help advance drug research on epigenetic targets

Cisbio Bioassays, developer of products, technologies and services used for assay development and drug screening and for in vitro diagnostics, has announced that it has signed a global distribution agreement with BellBrook Labs, provider of high throughput screening tools, for BellBrook Labs’ Transcreener EPIGEN Methyltransferase assay.

Under the terms of the agreement, Cisbio Bioassays will offer this universal, fluorescence polarization-based tool for drug discovery studies in the growing field of epigenetics to pharmaceutical and biotechnology researchers in Europe, the United States and Asia through its network of sales teams.

MRC Technology and Chinese Academy of Science collaborate to identify new targets for drug discovery

MRC Technology, a technology transfer charity and company, announced today it has entered into a strategic drug discovery collaboration with the Shanghai Institute of Biochemistry and Cell Biology (SIBCB), Chinese Academy of Science (CAS). The agreement will combine the SIBCB’s research expertise in generating potential new drug targets, with MRC Technology’s experience in further developing early stage research for pharmaceutical application and commercialisation. The focus of the collaboration is to fast track innovative drugable targets to create potent and selective novel therapeutics.

Silicone breast implants with spider silk-based coating show reduced side-effects in preclinical studies

AMSilk is developing a novel spider silk-based coating, called BioShield-S1, for silicone breast implants designed to reduce commonly known side effects that are initiated when the immune system reacts to the implants.

Preclinical tests conducted jointly with the University of Bayreuth, Germany and the Department of Trauma, Hand, Plastic and Reconstructive Surgery of the University of Wuerzburg, Germany, showed the efficacy of the implant coating. A first test in rats showed that coated silicone implants were accepted much better than implants without silk coating. In particular, capsular fibrosis and inflammation at the tissue border to the coated implants were significantly reduced.

Qualified human feeder cells for iPSC reprogramming

AMSBIO has announced the launch of Newborn Human Foreskin Fibroblasts qualified for induced Pluripotent Stem Cell (iPSC)* reprogramming. 

During cellular reprogramming the feeder layer can greatly affect the health of the cell culture and the success of the reprogramming. While a range of inactivated fibroblasts can be used as a support layer for pluripotent cell culture, not all will support mRNA reprogramming. Newborn Human Foreskin Fibroblasts (NuFF-RQ) have been functionally validated to support the generation of induced pluripotent stem cell (iPSC) colonies providing an optimised feeder layer during mRNA reprogramming.

Micro-volume measurement of nucleic acids and proteins

The BioDrop portfolio advances current micro-volume measurement of DNA, RNA, and protein with two core technologies: an in-built sample port, and the unique micro-volume CUVETTE.

The sample port delivers precise measurements and, with no moving parts, eliminates the need for calibration – unlike other micro-volume solutions.

DataTrace wireless data logger cuts validation time

Cherwell Laboratories is helping JPen Medical, a leader in on-site maintenance and calibration of medical equipment and devices, to cut hours off equipment testing and validation times. By using DataTrace self-contained, wireless, high-precision dataloggers for autoclave testing and validation, JPen Medical engineers can save as much as three hours at on-site visits. This is increasing productivity significantly – both for the company and its customers alike, as downtime is now minimised to a single autoclave cycle. 

Since no wiring is required, DataTrace probes can be readily used to measure temperature and pressure directly inside an autoclave for full validation with FDA 21CFR11 compliance and minimal equipment downtime. Traditional autoclave validation involves the complex and protracted task of introducing many thermocouple wires into an autoclave chamber.

Advanced pipetting technology helps optimize protein purification processes

Rainin Instrument, a METTLER TOLEDO subsidiary, has published a new white paper describing the optimization of protein/antibody purification. The paper, entitled “Optimizing Protein Purification Conditions,” highlights the use of Rainin PureSpeed Protein Tips. 

Using Rainin’s E4 XLS electronic pipette, PureSpeed tips allow for bidirectional sample flow over the purification resin bed, maximizing target protein capture by allowing the binding reaction to reach equilibrium. Potential concentration steps, which can actually degrade protein quality, are eliminated, saving time and costly rework.

The new Pentra DX Nexus high throughput haematology analyser

HORIBA Medical UK has announced the 'positive' results found from a study carried out by the Haematology Laboratory of St-Joseph St-Luc Hospital located in Lyon, France. Having tested the new Pentra DX Nexus, results show the high throughput haematology analyser to be reliable and efficient, as well as highly user-friendly and ergonomically designed. 

The Pentra DX Nexus series of haematology analysers are able to carry out complete blood count (CBC), 8-part differential, reticulocyte and erythroblast analysis, as well as body fluids measurements (CBF). Offering 50 parameters and a high throughput of 120 samples per hour, the Pentra DX Nexus is also compatible with Haemcell, HORIBA Medical’s integrated laboratory solution. The study used the lab reference system XE-2100 (Sysmex) to compare the functions and ergonomics of the workcell. This consisted of a Pentra DX Nexus analyser, SPS evolution slide maker/stainer and ABX Pentra ML data management system.

Pipette-friendly, two-part vial for difficult to handle liquid samples

Chemists gain a whole new perspective on sample handling with Vista Vial series chromatography vials from J G Finneran Associates. The patented, two-part design consists of a glass base and a polyethylene top that snaps together to form a standard 12x32mm autosampler vial.

The glass base provides a wide target for pipettes and is ideal for highly viscous and foaming samples. The polyethylene top is available with 8-425mm threaded, 9mm threaded or 11mm Snap Seal neck finishes offering chemists a choice of closure systems. 

Depending on the sample, disposal of vials is easier as the plastic can be incinerated intact without the need for closure removal.

Current antiretroviral therapy (ART) may lose its effectiveness in controlling the HIV epidemic

A study published in Epidemics reveals that drug resistance may lead to an increase in the number of people suffering from HIV.

There is an ongoing battle against HIV and AIDS worldwide, with an estimated 33.3 million people suffering from HIV globally. Many treatments to control HIV symptoms exist, however new research suggests that some of these may need to be reassessed. 

Antiretroviral therapy (ART) is currently the most efficient method in controlling the spread of HIV and is recommended as the key treatment for HIV/AIDS by a number of leading health associations globally.

Scientists identify depression and anxiety biomarker in youths

Scientists have discovered a cognitive biomarker – a biological indicator of a disease – for young adolescents who are at high risk of developing depression and anxiety. Their findings were published (28 November), in the journal PLOS ONE.

The test for the unique cognitive biomarker, which can be done on a computer, could be used as an inexpensive tool to screen adolescents for common emotional mental illnesses. As the cognitive biomarker may appear prior to the symptoms of depression and anxiety, early intervention (which has proven to be one of the most effective ways of combatting mental illness) could then be initiated.

RNA kits for next generation sequencing workflow

AMSBIO small RNA and mRNA sample library construction kits have been designed to enable fast and cost-effective Next-Generation Sequencing (NGS).

As a disruptive technology, NGS is rapidly changing the landscape of biomarker research, clinical diagnostics, and drug development. NGS technologies include a number of methods that are grouped broadly as template preparation, sequencing and imaging, and data analysis. The unique combination of specific protocols distinguishes one technology from another and determines the type of data produced from each platform. However, the basic sample process requirements, so called library construction, are shared among all of the technology platforms. 

AMSBIO's sample library construction kits reduce NGS workflow complexity, shorten sample library preparation time and labour, and minimise errors by eliminating extra steps and optimising the experiment protocol. With input RNA requirement as low as 0.5ng, AMSBIO kits can be used for the sample preparation from rare and difficult to obtain sources, such as the pathological samples. They can also be used for the situations where the samples are degraded as with formalin fixed paraffin embedded (FFPE) tissue samples.

AMSBIO kits are designed to enable you to query thousands of small RNA sequences with unprecedented sensitivity and dynamic range for both small RNA discovery and profiling applications. In addition the kits can be used to find novel microRNAs, characterize variation such as isomirs with single-base resolution, and analyse the differential expression of all small RNAs in any sample without prior assumptions. Supplied in a convenient, easy-to-use all-in-one format - AMSBIO sample library construction kits are also proven to quickly generate full sequence from any poly-A tailed RNA with the simple and cost-effective RNA Sample Preparation kit to analyse novel transcripts, novel isoforms, alternative splice sites, rare transcripts, and cSNPs in a single experiment. 

IMSOL Imaging system key to spinal injury research

An imaging system from Image Solutions (UK) Ltd (IMSOL) is central to research being carried out by scientists at Cardiff University into how stem cells can be used to treat spinal injuries. 

Headed by Professor Bing Song, the University’s Institute of Tissue Engineering and Repair is two years into a five-year, €1.76m European Research Council project to investigate how controlling the migration of neural stem cells influences the repair of spinal cord injuries. The team is focusing on how minute electric fields can be used to guide these stem cells to specific sites of injury as part of an overall repair therapy. 

“We are trying to optimise the conditions needed in order to establish the best scenario for guiding the stem cells to their required locations. The wide field deconvolution system is one of the most powerful imaging systems available and is saving us a huge amount of time because it is possible to observe so many different events in one experiment,” explains Professor Song.

Green fluorescent proteins are introduced into the stem cells beforehand. Once they arrive at the scene of the injury and the stem cells begin to divide and differentiate, these proteins can be switched on and off and therefore detected as bright green fluorescence, depending on which gene they represent. This way the scientists can see exactly where the stem cells are relative to the damaged nerves. 

Professor Song’s imaging system is a high throughput microtiter plate based wide field deconvolution restoration microscope. It is built on an Olympus IX71 inverted microscope with a 250 watt xenon lamp and a LED transillumination light source. The plate stage can hold multiple format plates (96-, 384- and 1536 well microtiter plates) as well as traditional slides. Three high-resolution objectives are supplied with the system to address a wide range of optical imaging. The system utilises a 10 position excitation filter wheel and a 6 position emission wheel for wide range of fluorescent dyes. 

So impressed is he with the results generated by the imaging system from Image Solutions that Professor Song hopes to invest both in more sophisticated imaging technology in order to see individual cell-to-cell interactions, and single-cell manipulations in a 3D environment.

ICON Central Laboratories launches iSite portal for investigator sites

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the launch of iSite, a secure web-based portal that drives efficiency by providing investigators 24-hour access to study-specific laboratory information from ICON Central Laboratories. 

Isite is an easy-to-use portal that allows investigators and other site personnel to access electronic laboratory reports for their active studies at any time. It includes user-friendly navigation, filtering and report management and provides investigators customised views of reports by study, site, subject or visit date. iSite also includes email alert functionality which notifies investigators when new reports become available. 

“We are continuously looking to introduce innovative technology solutions that drive efficiency and improve performance,” commented Tom O’Leary, President, ICON Central Laboratories. “iSite provides investigators a much needed solution for accessing important study-specific information in the most rapid, secure and convenient way possible.” 

A future release of iSite is in development and will provide sites with study-specific performance metrics and additional tools such as customised electronic laboratory manuals which will be created by ICON’s Firecrest technology. ICON’s Firecrest delivers an innovative suite of training and study management tools which can significantly improve the compliance, consistency and execution of study-related activities at investigator sites.

Use of warm stages in fertility laboratories to assess sperm viability

Leaders in temperature controlled microscopy, Linkam Scientific Instruments, have been chosen as suppliers of warm stages to a number of laboratories in the UK for sperm assessment. 

The concentration, motility and morphology of sperm are universal indicators of fertility- regardless of whether the male is human or an animal. 

Fertility is a big health issue within the UK: about 25% of couples are affected by fertility problems, with around 35% of men sub-fertile and 2% infertile. Many NHS hospitals and private labs offer fertility testing to couples and for men that means assessment of a semen sample. 

Animal fertility assessment is crucial for animal husbandry in the UK: farmers need to know that their breeding animals are healthy before the breeding season so that lambing and calving can be organised effectively. Linkam warms stages are designed to hold a specified temperature to +/- 0.1°C from ambient to 60°C. They are an accurate temperature control platform for inverted or upright microscope applications where it is crucial to maintain at 0.1°C stable temperature in the sample whether mounted in a petri dish or on a microscope slide. 

Sperm motility is temperature dependent. To establish in-vivo fertility, observations need to be carried out at body temperature to mimic conditions within the body: for humans, bulls and rams is exactly 37°C. The use of a precise, accurate heated warm stage is an essential part of the assessment. This is to ensure the assessment is conducted at a stable and specific temperature. Within the design of this Linkam warm stage, a platinum resistor temperature sensor is used for higher accuracy and stability. 

A sophisticated CAD designed bi-filar heating element covers the entire working surface which provides a uniform temperature distribution in the sample slide. The Linkam stage gives the assessor the confidence that all samples are observed at a stable, set temperature.

A sample is placed onto a clean glass slide and covered with a coverslip to provide a chamber. 

The weight of the cover slip spreads the sample evenly. Scientists initially look for aggregation or agglutination, and the presence of non-spermatozoa cells. The preparation is then observed at 400x magnification with a phase contrast microscope to observe motility. Each Linkam-designed warm plate is incredibly thin, as little as 0.5mm. This ensures that high resolution objective and condenser lenses can be used. Approximately 200 spermatozoa are counted and categorized to determine the percentage of each category. Spermatozoa can be classified as progressively motile, non-progressively motile or non-motile. The percentage of progressively motile sperm is important to fertility assessment. 

Linkam warm stages are found in cell biology labs, veterinary hospitals, hospitals and IVF clinics all over the world. The Linkam warm stages provide a simple, accurate, low cost temperature controlled platform that can heat/cool samples from ambient to 60°C.

Lab M launches immunomagnetic separation product for isolation of E. coli 0104

Lab M has launched Captivate O104, a new addition to its range of immunomagnetic separation (IMS) products. Captivate O104 is designed to meet the increasing need to rapidly test fresh sprouted seeds for the presence of E. coli O104.

Captivate O104 is used in the isolation of E. coli O104 (including E. coli O104:H4) from food, animal feed, and environmental samples. While E. coli O104:H4 is generally quite rare in humans, in 2011 it was responsible for a serious outbreak of illness in Europe associated with the consumption of fresh sprouted seeds, prompting calls for tighter rules on testing.

One of the challenges with E. coli O104:H4 is that it is biochemically ambiguous and therefore difficult to isolate from other STEC strains using conventional culture methods. IMS is the only procedure that makes specific isolation of E. coli O104 possible in a way that results in a viable microbiological culture.

Lab M’s expertise in immunomagnetic separation dates back many years and Captivate™is one of the company’s best selling product ranges around the world. As well as producing specific sets of antibody-coated paramagnetic particles for separating targeted microorganisms, the company also offers a highly respected consultancy and custom coating service.

Confocal imaging and cellular stimulation with minimal phototoxicity

Olympus has released the new FluoView FV1200 confocal laser scanning microscope, optimised for live cell imaging. The new system uniquely combines the accuracy of the newly engineered IX83 frame with enhanced fluorescence sensitivity and simultaneous laser stimulation of cells, making it ideal for advanced life science applications such as FRAP, FLIP and photo-activation. In particular, the new highly-reflective, silver-coated galvanometer scanning mirrors and dual channel GaAsP FluoView PMT module both act to maximise light transfer and detection. This allows for reduced laser power, protecting against the effects of photobleaching and phototoxicity. 

The generation of insightful confocal imaging data from living cells depends on optimally balancing laser power and sensitivity to minimise the effects of phototoxicity and photobleaching. To meet this challenge, the FV1200 is designed to maximise sensitivity via a new dual channel GaAsP FluoView high sensitivity PMT module, which delivers up to 45% quantum efficiency. In addition, Peltier cooling reduces electrical noise by 80%, increasing signal to noise ratio. 

The new high reflection silver coating on the galvanometer scanning mirrors of the FV1200 ensures durability along with improved reflection efficiency for excitation and emission paths, increasing light efficiency in the visible range by 5 - 15% and IR reflectance up to 22%. This allows for a decrease in laser power, while providing the same level of fluorescence sensitivity. In combination with the unique Olympus SIM scanner, which allows simultaneous illumination and stimulation, it is possible carry out advanced localisation experiments such as FRAP and FLIP, without fear of damaging cells. 

Accurate confocal imaging also requires the upmost thermal and mechanical stability, as is provided by Olympus’ new fully automated IX83 frame. To further improve accuracy, the Olympus Z-drift Compensation Unit maintains automatic precision focus without damaging cells, and uniquely offers both a ‘one-shot’ and a ‘continuous’ focus mode. In this way, even the longest time-lapse experiments will generate reliable and accurate results. 

To maximize application flexibility, the FV1200 combines the GaAsP PMT with the high dynamic range of three standard multi-alkali PMTs. The new GaAsP module is also compatible with the FluoView FV1000, providing an opportunity to easily enhance the performance of the previous system. System operation is controlled via the new FluoView ASW Version 4.0 software, improving direct file access and analysis, and providing a common platform for both the FV1000 and FV1200. 

Dr Buelent Peker, Product Manager at Olympus Microscopy Europa, commented: “Given the trend toward longer observation periods using living cells, the new FV1200 system meets the needs of researchers requiring reliable time lapse imaging in combination with highly accurate and sensitive fluorescence observations and simultaneous cellular stimulation. In this way, it enables researchers to obtain reliable data from living cells, while minimising the risk of causing death or triggering abnormal cellular behaviour.”

Randox announces CE Marking of its sexually transmitted infection (STI) multiplex array

Sexually transmitted infections (STIs) are on the increase worldwide and present a major challenge to world public health. This rise in STI cases shows that current measures, including existing technologies and screening programmes cannot cope with clinical need. STIs are of significant medical, social and economic importance affecting up to 25-30% of young adults, with the developing world having a disproportionate burden of disease. STIs can be difficult to diagnose because of atypical or asymptomatic presentation and left untreated can result in serious health problems including infertility or complications during pregnancy. Those with untreated STIs can also act as reservoirs for future infection.

To avoid preventable health complications and to encourage more responsible sexual health practices, Randox has developed the STI Multiplex Array that can simultaneously detect 10 of the most prevalent STIs from a single urine or swab sample, in a single test within 5 hours. These STIs include Chlamydia trachomatis, Neisseria gonorrhoea, Trichomonas vaginalis, Treponema pallidum (syphilis), Herpes simplex 1 & 2, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum and Haemophilus ducreyi.

In addition to providing the most comprehensive STI screen available, testing for multiple STI pathogens can identify secondary infections, which are present in greater numbers than previously thought, and allow specific treatments for all infections diagnosed. The accuracy and comprehensive diagnostic ability of the Randox STI Multiplex Array compensates for many of the current diagnosing limitations and has the potential to revolutionise STI diagnosis. This will improve patient outcome and reduce the social and economical burden of such pathogens. Using this test has added benefits through more appropriate use of antibiotics, which will reduce the potential for antibiotic resistance.

The CE marking of the STI Multiplex Array signifies that this groundbreaking test is suitable for the accurate diagnosis of STIs in a clinical setting and provides further evidence that Randox continues to develop innovative diagnostic solutions to meet the increasing demands of healthcare providers worldwide.

Precision infrared calibrator

Fluke Precision Infrared Calibrators 4180 and 4181 are tailor made for the calibration of infrared thermometers and thermal imaging cameras. Their precision, portability and ease of use make them the ideal candidates for applications in laboratory, factory or in the field.

Both instruments come with an accredited calibration from one of the world’s most trusted temperature calibration laboratories, sample calibration procedures for Fluke thermometers built right in, and everything you need to get started making high-quality infrared thermometer calibrations. Hence you will receive conclusive, consistent and traceable results in the temperature range between -15°C and +500°C. A convenient handle and a maximum weight of 9.5 kg ensure optimum portability.