The FDA has approved Abbott Molecular’s genetic diagnostic, Vysis EGR1 FISH Probe Kit, to detect acute myeloid leukaemia (AML).

The new in vitro test is the third of Abbott’s FISH assays to be cleared for oncology applications in the US in the past two months.

Stafford O'Kelly, Head of Abbott's Molecular Diagnostics Business said that the medical technology “can identify which AML patients have the chromosomal abnormality upon diagnosis and provides physicians with another clinically validated tool to assess a patient's overall prognosis”.

The Kit’s technology detects chromosomal deletion in the bone marrow, and can be used in addition to cytogenetics, other biomarkers, morphology and other clinical information, at the time of AML diagnosis to determine prognosis.

Each year, more than 12,000 people are diagnosed with AML, which is a rapidly progressive disease. Current standard procedure involves aggressive chemotherapy drugs, while some patients may require a stem-cell transplant to replace unhealthy bone marrow with leukaemia-free stem cells.  

Part of Abbott, Abbott Molecular is a leader in molecular diagnostics, analysing DNA and RNA at the molecular level. Abbott Molecular's tests aim for earlier detection or diagnosis, to provide information of appropriate treatment, and improve monitoring of disease progression.

Abbott is a global healthcare company, which discovers, develops, manufactures and markets pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and commercialises its products in more than 130 countries worldwide.

A new childcare product designed to improve posture and assist spinal development has been launched by a UK company.

The PosturePadJunior wedge cushion (pictured) from Derby-based Jolly Back Enterprises was developed with support from the Healthcare and Bioscience iNet, which is part-financed by the European Regional Development Fund (ERDF).

Designed by physiotherapist Lorna Taylor, the product was launched during National Back Care Awareness Week.

Taylor received an iNet Innovation, Advice and Guidance grant, which enabled her to design and test the wedge cushion prior to commercialisation. She is working on a DVD to train teachers and nursery managers in manual handling and back care.

The same company launched the Jolly Back chair earlier this year, using the same wedge-shaped cushion technology to prevent or reduce back pain. The product has 23 UK distributors and has sold worldwide.

“As a children’s physio, I am concerned at how child development is being adversely affected by current lifestyles,” said Taylor, who noted that correct positioning of babies can “allow core strengthening of the back and neck”.

Taylor described the PosturePadJunior wedge cushion as “a simple means of naturally supporting the spine for comfort and physical development”.

iNet advisor Dr Ros Graves commented: “Lorna has shown incredible resourcefulness by coming up with simple but effective products and bringing them to market so efficiently. The potential impact of all her ideas is enormous so we are delighted to have been able to help.”

The Healthcare and Bioscience iNet is an initiative delivered by Medilink East Midlands that assists companies and inventors in the healthcare sector to develop new technologies, products and services. It brings together firms, academics and public service representatives.

A man paralysed from the neck down was able to high-five his girlfriend through a robotic arm, which he directed using only his mind.

Tim Hemmes, 30, controlled the arm through an implanted microchip in his brain. Tim is quadriplegic following a motorcycle accident seven years ago.

Tim said: “It wasn't my arm but it was my brain, my thoughts. I was moving something...I don't have one single word to give you what I felt at that moment. That word doesn't exist.”

Scientists at Pittsburgh University attached the robotic arm, which Tim directed by looking at an electronic grid.

“We really are at a tipping point now with this technology,” said Michael McLoughlin of the Johns Hopkins University Applied Physics Laboratory, Maryland, USA, which developed the humanlike arm in a $100 million project for DARPA, the Pentagon’s research agency.

The arm that Tim tested was under observation by the FDA, who allowed the chip to remain implanted in his brain for a month to test the technology’s ability to move three-dimensionally.

Tim said that learning to operate the arm was like learning to drive a car with a manual transmission. But on his final day with the arm, Tim managed to touch hands with scientists and even high-fived his girlfriend.

Monkeys at Duke University have previously been trained to feed themselves using thought-powered virtual arms, and a project called Braingate has allowed a number of paralysed people to use computers or make simple movements with prosthetic arms using only their thoughts.

The FDA has approved Abbott Molecular’s Vysis ALK Break Apart FISH Probe companion diagnostic for lung cancer patients.

The test detects all ALK gene rearrangements and is the only FDA-approved diagnostic assay to predict response using Pfizer’s targeted therapy Xalkori for patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

Dr Mark Brecher, Chief Medical Officer of LabCorp, said that the personalised medication “will play an even larger role in cancer care, assisting physicians in administering the treatments best suited to the disease.”

The Probe Kit for Xalkori uses Fluorescence In-Situ Hybridisation (FISH) to detect a specific rearrangement in the ALK gene.

Approximately 3-5% of NSCLC tumours are characterised by genetic rearrangements in the ALK gene. When this gene is altered by combining ALK with other gene sequences, the pathway becomes constitutively active causing mutation. Xalkori inhibits the mutant ALK protein, and halts the growth of cancer cells.

LabCorp’s Centre for Molecular Biology and Pathology (CMBP) supported clinical studies of the new diagnostic and collaborated with Abbott Molecular in the analytical validation of the product.

According to LabCorp, approximately 6,500-11,000 people will develop advanced ALK-positive NSCLC in the US in 2011.

The Vysis ALK Break Apart FISH Probe test is available for patient testing through LabCorp, which is one of the largest medical diagnostic companies in the US.

Belfast Health and Social Care Trust has licensed a new rapid meningitis diagnostic test for worldwide exclusive marketing rights.

The new test, developed by scientists at the Royal Victoria Hospital and commercialised by Irish start-up company HiberGene Diagnostics, uses an emerging molecular method known as loop-mediated isothermal amplification (LAMP), that can to provide reliable diagnosis within an hour.

Meningitis is a difficult disease to diagnose as symptoms are typically flu-like. Standard laboratory tests take at least 24 hours to process, and there is a need for rapid and accurate results to allow earlier confirmation to enable earlier treatment.

Brendan Farrell, CEO of HiberGene Diagnostics said: “We are particularly pleased to have secured exclusive rights to the meningitis test from the Belfast Trust. Clinical validation of the test has shown a sensitivity of 100% and a specificity of 99.7% which is excellent.”

Consultant Paediatrician Professor Mike Shields, who led the research, said: “Meningitis presents a clinical challenge for the emergency department doctor because the patient's symptoms can be non-specific.

“No doctor wants to send a seriously sick child home, which is why this new diagnostic test holds such promise. When this test is available it will have the potential to save many lives.”

HiberGene Diagnostics Ltd is a start-up client company of NovaUCD, the Innovation and Technology Transfer Centre at the University College Dublin.

The company plans to market the test in the first half of 2012 and is in discussions with potential distribution partners in the US and Europe.

The FDA has approved a new diagnostic test that will help save hundreds of thousands of lives of AIDS patients with fungal meningitis.

The rapid blood test, CrAg Lateral Flow Assay, requires no equipment, able to diagnose the early presence of cryptococcosis, a leading cause of AIDS-related deaths in developing countries.

The point-of-care dipstick was developed by Tom Kozel, Professor of Microbiology at the University of Nevada School of Medicine, and Sean Bauman, President and CEO of IMMY (Immuno-Mycologics) in Oklahoma. Mr Bauman commercialised the product to make it available at low cost to patients in developing countries.

Sean Bauman, President and CEO of IMMY (Immuno-Mycologics), Oklahoma, and developer of the test, said: “A health-care provider can give the test, observe the results, and administer the first dose of oral medication, all within a few minutes, resulting in a life that has truly been changed for the better.”

Current diagnostic tests for cryptococcosis are not suitable for use at resource-limited locations. The tests require special laboratory equipment and refrigeration for storage.

Mr Kozel commented that early identification and treatment is essential to beat the disease, as late diagnosis means antifungal therapy will likely fail in resource-limited countries.

The United States' Center for Disease Control and Prevention has published a fact sheet and established a ‘call to action’ of equipping half of all AIDS clinics in Africa and Asia with the test by 2015, estimating that 50,000 to 100,000 lives will be saved every year.

A diagnostic screening kit that measures platelet function at the point of care is being used to assess the need need for blood products and drugs in patients who bleed post-operatively.

Surgeons and anaesthetists at the Lancashire Cardiac Centre in Blackpool Victoria Hospital are using Plateletworks from HORIBA Medical as a rapid test of whether patients have enough functioning platelets to allow haemostasis.

The Plateletworks kit delivers quantitative and qualitative platelet assessments in minutes, enabling clinicians to make informed decisions at the point of care.

The kit is also enabling clinicians at the Centre to swiftly assess patients on anti-platelet therapy (such as Clopidogrel) who require urgent surgery, so that they can be operated on at the earliest safe opportunity.

Plateletworks is also being used to evaluate new techniques, such as optimisation of the perfusion process to reduce platelet loss and hence need for transfusion.

Whole blood samples can be used with the kit, saving time in sample preparation. The tests can be processed on a HORIBA Medical haematology analyser in less than five minutes.

“By using Plateletworks to rapidly assess platelet function we have noted a reduction in post-operative bleeding take backs,” said Mr Nidal Bittar, consultant cardiothoracic surgeon at the Centre.

“We have also been able to improve a patient’s journey, since we can address the cause of bleeding quickly without delay and we need only transfuse if absolutely necessary.

“Furthermore, we can protect low responders to anti-platelet therapy from risk of embolus during stent insertion procedures, for example.”

HORIBA Medical UK specialises in automated in vitro diagnostic systems for haematology, with a clinical support network of 31 professionals.

Human papillomavirus (HPV) testing should become the primary screening tool to rule out cervical cancer, claims a new study.

The ATHENA trial recommends testing for the two most dangerous strains of HPV – HPV16 and HPV18 – as it will identify more precancerous lesions than using the current screening technology of cytology.

The study, publishing in The Lancet Oncology, states that cytology should be reserved for women who test positive for HPV, deciding which women need immediate colposcopy.

HPV testing would be an efficient option and reduce manpower requirements in laboratories, providing “potentially cost-effective and safe cervical cancer screening”, commented the authors of the study.

Guglielmo Ronco and colleagues from the Centre of Cancer Prevention in Turin, Italy said: “The results also provide useful information about triage strategies for parts of the world where high-quality cytology has been difficult to implement and combinations of HPV tests might eventually offer a more sustainable option.”

The ATHENA study aimed to evaluate the performance of HPV testing compared with liquid-based cytology, and to formulate more effective treatment ideas for HPV patients.

The trial involved more than 47,000 American women over the age of 25, who attended regular cervical screenings within a 15-month period.

HPV tests detected a considerably larger amount of existing high-grade precancers in 92% of women who had colposcopy compared to 53.3 % who were given cytology.

The study also found that a combination of HPV with cytology was of little benefit compared with HPV testing alone. The combination method improved accuracy by only 4.7%, but increased the number of screen positives by more than a third.

HPV16 and HPV18 currently account for 70% of invasive cervical cancer cases, with approximately 27% of women being infected with HPV in the US. Treatment management for HPV patients remains unclear, but HPV DNA testing is widely known to be more effective than cytology-based screening.

Two unique handheld devices from a Welsh company that monitor the blood clotting status of patients are set for launch in the US.

The CoagMax (pictured) and CoagLite devices from Microvisk Technologies are a point of care test (for clinicians) and a home test (for patients) respectively to set the correct dosage of the anti-coagulation drug Warfarin.

The Microvisk devices, which have attracted strong interest from US distributors, are set to be trialled with 250 patients in Florida from October, with product launches scheduled for mid-2012.

In both devices a single-use SmartStrip with embedded sensors and a memory chip measures the clotting speed of blood from a fingerprick drop, and the results are displayed on a handheld reader.

The SmartStrip is based on Micro-Electro-Mechanical System (MEMS) technology, used in the iPhone and Nintendo Wii. This provides a more accurate result from a smaller blood sample than existing devices.

Multi-centre clinical trials of CoagMax and CoagLite are under way in the UK and Germany, where product launches are scheduled for early 2012. The devices will be showcased at Medica 2011 in November.

John Curtis, CEO of Microvisk, said: “We are delighted at the overwhelming interest shown by US distributors and potential partners in our CoagMax and CoagLite devices. We have been expanding our UK manufacturing facilities and are recruiting additional staff as we prepare for European product launches in early 2012.”

Microvisk has established a US operation in Florida. Bill Moffitt, the company’s US Chairman, commented: “These innovative devices will transform the way that blood testing is carried out, and Microvisk now has the opportunity to capture a substantial share of the market for doctor’s office and home tests for Warfarin patients.”

Over a million new patients each year use Warfarin to treat blood clotting disorders. They currently need regular blood tests at a surgery or clinic – but the Microvisk devices will enable them to test their blood clotting at home.

Based at St Asaph Business Park in North Wales, Microvisk specialises in medical testing devices based on MEMS technology.

Draft guidance from NICE’s Diagnostics Assessment Programme, published for consultation, does not support the use of two genetic tests to diagnose familial hypercholesterolaemia (FH) or inherited high cholesterol.

The provisional recommendations do not support the use of Elucigene (from Gen-Probe) or LIPOchip (from Progenika) by the NHS in England to confirm a diagnosis or screen relatives of someone diagnosed with FH.

FH is caused by an inherited genetic mutation that reduces the rate at which cholesterol is cleared from the blood. The condition affects an estimated 100,000 people in the UK, and can result in coronary heart disease if not diagnosed and treated.

Currently, FH is diagnosed through a combination of clinical signs and DNA testing. The Elucigene and LIPOchip tests can only identify a subset of the genetic mutations that cause FH. Therefore, NICE’s Diagnostics Advisory Committee concluded that using CGA (comprehensive genetic analysis) for diagnosis of FH and targeted DNA testing for screening was more clinically and cost-effective than either test.

Professor Adrian Newland, Chair of the Diagnostics Advisory Committee, said the Committee considered that “even though Elucigene and LIPOchip are less costly tests than CGA, because they are less sensitive the cost savings would be more than offset by the lower health outcomes associated by false negative tests and the inability to undertake cascade testing using a targeted DNA test.”

However, he commented, “It remains the case that only a fraction of people in England are identified as having FH, often with tragic consequences for the majority who are not.” The provisional NICE clinical guideline was “a pragmatic blueprint” for preventing many unnecessary deaths through the use of CGA and targeted DNA testing.

The consultation closes on 23 August, and final guidance is expected in December.