Translational Sciences Corporation Receives FDA 510(k) Clearance For Commercialization Of OncoTrac™ In The United States

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Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 27 Nov 2011 - 1:00 PST

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Translational Sciences Corporation (TSC) announced that it has received FDA 510(k) clearance for commercialization of its OncoTrac™ medical imaging software. OncoTrac™ is designed for efficient quantitative assessment of treatment response of metastatic tumors including breast, lung, colorectal, prostate, and lymphoma. The OncoTrac™ family of products provides a structured workflow solution for cancer practitioners and researchers to report precise measurements of solid and metastatic tumors for routine clinical care and cancer drug trials. As a vendor-neutral platform, OncoTrac™ software architecture is suitable for use in daily radiology practice, and can be easily integrated into most existing Picture and Archive Communications Systems (PACS) environments without any product customization. OncoTrac™ will be available for demonstration at the Annual Meeting of the Radiological Symposium of North America (RSNA) in Chicago in November 2011.

OncoTrac™ enterprise software facilitates tumor response assessment using widely accepted standards such as RECIST 1.0, RECIST 1.1, and WHO, as well as emerging standards such as the Choi criteria. Assessments using these criteria are commonly required by clinical trial protocols and are often submitted as primary and secondary end-point data in new anti-cancer FDA drug approval applications. Yet, not all clinical cancer research reports tumor response correctly. OncoTrac™ is designed to assure conformity to response assessment standards and to aid compliance with established clinical research standards including FDA Good Clinical Practice (GCP) and Part 11 Electronic Medical Records.

"With OncoTrac™, formal response assessment methods used in clinical trials can be efficiently implemented in routine radiological cancer evaluations in support of patient management," said Howard Pinsky, CEO of Translational Sciences Corporation. "Subject assessment data are integrated into existing research workflows, thereby providing capabilities comparable to those performed at core imaging laboratories in support of drug applications."

OncoTrac™ features advanced report generation capabilities that provide additional value to ordering oncologists, radiologists, and cancer patients through improved visualization of quantitative response to therapy. Reports can be exported and stored in both a PACS system and in an electronic medical record (EMR).

OncoTrac™ was originally developed by Mint Medical GmbH at the German Cancer Research Center (Heidelberg) and is currently in use at major cancer centers in Europe under the brand Mint Lesion™.

Additional References Citations Article adapted by Medical News Today from original press release. Source: Translational Sciences Corporation
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Translational Sciences Corporation. "Translational Sciences Corporation Receives FDA 510(k) Clearance For Commercialization Of OncoTrac™ In The United States." Medical News Today. MediLexicon, Intl., 27 Nov. 2011. Web.
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Translational Sciences Corporation. (2011, November 27). "Translational Sciences Corporation Receives FDA 510(k) Clearance For Commercialization Of OncoTrac™ In The United States." Medical News Today. Retrieved from
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MedUni Vienna: Development Of The Brain Network In The Foetus Now Measurable For The First Time In The Womb

A team of researchers at the MedUni's Clinical Department of Neuroradiology and Musculoskeletal Radiology has demonstrated for the first time ever that there are foetal brain developments that can be measured using functional magnetic resonance tomography in the womb. This means, says study leader Veronika Schöpf, that pathological changes to brain development will be detectable earlier than they are currently and appropriate measures can be taken in good time.
In the study, 16 foetuses between the 20th and 36th weeks of pregnancy were measured. Measurements were taken of the brain's resting state networks. These networks remain in a state of readiness at rest and their activity increases after appropriate stimulation. The examinations are completely stress-free for the mothers and extend "normal" MRI scans by just a few minutes.
Functional defects are detected earlier
"We have been able to demonstrate, for the first time ever, that the resting state networks are formed in utero and that these can be imaged and measured using functional imaging," explains Schöpf, who is part of the working group led by Daniela Prayer, Head of the Department of Neuroradiology and Musculoskeletal Radiology and head of the world's leading centre for pre-natal magnetic resonance imaging at the MedUni Vienna.
This discovery means that, in future, the developmental progress of brain activity in the foetus can be measured and other findings and prognoses made regarding possible malfunctioning processes. As a result, functional defects, such as of the optic nerves or motor system, can be detected while the foetus is still in the womb - an achievement that was previously impossible so that parents can be offered more informed advice and counselling, for example.
Article adapted by Medical News Today from original press release. Source: Medical University of Vienna
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Mammotome Marks Key Milestones As It Grows U.S. And Global Presence

Mammotome Marks Key Milestones As It Grows U.S. And Global Presence@import "/css/pagelayout.css";@import "/css/default.css";@import "/css/defaultnews.css"; Your MNT
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Article Date: 27 Nov 2011 - 1:00 PST

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About 16 months after becoming a division of Devicor® Medical Products, Inc., Mammotome the company that helped create and build the vacuum-assisted breast biopsy market has made significant progress toward its new product development and growth goals.

"As the only company with a singular focus on breast biopsy, Mammotome is re-focused, re-energized, and re-committed," says CEO Tom Daulton. "We've spent more than a year solidifying our foundation for growth through product development and acquisition efforts. We're excited to start sharing new products and initiatives with the clinicians who've helped to make Mammotome the trusted, market-leading brand it is today."

With the support of a world-class, cross-functional leadership team, Daulton points to the development of next generation products and platforms as the primary driver of growth and innovation. The first of these products a single insertion, tetherless device for use in ultrasound-guided biopsies is currently undergoing FDA approval and is slated to be commercially available globally early next year.

In addition to preparing for next year's new products rollout, several major milestones were reached in 2011:

Mammotome continues to build its global team with the best and brightest talent in the industry, adding approximately 100 new team members in the past year. With offices in the United States, France, Germany, Italy, Japan, China, Korea and Mexico, the company now employs more than 400 people globally.

A new manufacturing facility in Tijuana, Mexico, is now fully operational. The plant produces nearly all disposable Mammotome products globally.

Devicor acquired the neoprobe® GDS portfolio of products from Neoprobe Corporation. The acquisition expands the company's dedicated breast care portfolio and product offerings as Devicor works towards its goal of building a $500 million global medical device business.

Construction began on a new Design and Education Center that grows the company's presence at its Sharonville, Ohio headquarters. The expansion is set to be completed in spring of 2012 and will help Mammotome continue its leadership in hands-on customer training.

"We've celebrated some great accomplishments over the past year, but we do so with our eyes firmly on the future," says Daulton. "Our number one priority in every step we take along the way is to work toward our mission of developing superior, minimally-invasive tools and technologies that help clinicians best diagnose and care for their patients."

Additional References Citations Article adapted by Medical News Today from original press release. Source: Mammotome
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Keeping One's Eyes On The Goal Despite Stress

Stressed people fall into habits and their behaviour is not goal-directed. That the neurotransmitter norepinephrine plays a decisive role here is now reported in the Journal of Neuroscience by scientists from Bochum led by Dr. Lars Schwabe (RUB Faculty of Psychology). If the effect of norepinephrine is stopped by beta blockers, the stress effect does not occur. "The results may be important for addictive behaviours, where stress is a key risk factor" said Schwabe. "They are characterised by ingrained routines and habits."

Stress experienced with and without beta blockers

In a previous study, the Bochum researchers had already found that stress affects goal-directed behaviour during a learning task. Now they explored how these negative effects can be prevented. Schwabe and his colleagues subjected half of the participants to a stressful situation. Beforehand, the researchers administered the drug propranolol, a beta blocker, to part of the stressed group. This occupies certain receptors and thus prevents norepinephrine from working. The remaining subjects took a placebo pill.

Learning with cocoa and orange juice

Then, all the subjects learned that they received cocoa or orange juice as a reward if they clicked on certain icons on the computer. After this learning phase, the participants were allowed to eat either as many oranges or as much chocolate pudding as they wanted. "That weakens the value of the reward" explained Schwabe. "For someone who eats chocolate pudding, the cocoa loses its appeal. And someone full of oranges has less craving for orange juice." In the subsequent test series, non-stressed subjects who had eaten chocolate pudding clicked less frequently on the icons which led to a reward of cocoa. Non-stressed participants who had previously eaten oranges opted less for symbols that were associated with orange juice.

Norepinephrine mediates stress effects

The behaviour of the stressed subjects who had been administered a placebo tablet was completely different. Regardless of what they had eaten, they continued to choose both the symbols associated with orange juice and with cocoa. So they stayed in their habits. The behaviour of the stressed subjects in the beta-blocker-group, on the other hand, was just as goal-directed as that of the subjects who had experienced no stress. If they were full of chocolate pudding, for example, they rarely chose the symbols which led to a reward of cocoa. This result demonstrates that norepinephrine mediates the effect of stress and that beta blockers can avert the negative consequences of stress. The study was funded by the German Research Foundation and the RUB's Rectorate programme.

Article adapted by Medical News Today from original press release. Source: Ruhr-Universitaet-Bochum
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Moderate Alcohol Intake Linked To Lower Female Diabetes Risk

Females in middle age who drink alcohol moderately and consume large amounts of refined carbohydrates have a 30% lower chance of developing diabetes type 2, compared to women with similar dietary habits who don't drink, researchers from the Harvard School of Public Health wrote in the American Journal of Clinical Nutrition. Examples of refined carbohydrate foods include sugary drinks, white bread, some pastas, and (polished) white rice.

The authors explained, as background information to their report, that very little prior research has focused on whether there might be an association between glycemic index load, glycemic index, alcohol consumption and diabetes type 2 risk.

Dr. Frank Hu and team set out to determine what impact alcohol intake (or lack of it) might have on diabetes risk in middle aged women whose refined carbohydrate (carb) intake was high. They tracked 81,827 women for 26 years. The women had participated in the Nurses' Health Study and were all free of diabetes type 2 when the study began.

Their cumulative averages of glycemic index, glycemic load, total carb intake and total alcohol intake were calculated every two to four years using questionnaires.

During the follow-up period 6,950 participants developed diabetes type 2.

They found that the women with a high refined-carb intake who consumed moderate amounts of alcohol had a 30% lower chance of developing diabetes type 2 compared to women whose refined-carb intake was also high but consumed no alcohol.

In an interview with Reuters news agency, Dr. Hu said:

"If you eat a high carb diet without drinking alcohol, your risk of developing diabetes is increased by 30 percent.

However, if you eat a high carb diet, but (drink) a moderate amount of alcohol, the increased risk is reduced."

The authors concluded in an Abstract in the journal:

"Our findings suggest that a higher alcohol intake (=15 g/d) attenuates the positive association between GL and T2D incidence."

The moderate drinkers in this study consumed an average of 0.8 once (24 grams) of alcohol each day, the equivalent of approximately two drinks each week. A very small percentage were classed as heavy drinkers - consuming at least two ounces of alcohol each day - they did not have a lower diabetes type 2 risk.

The authors stressed that their study should not encourage people to start drinking if they do not do so now. Rather, they encourage a diet low in refined carbs and high in whole grains. If you are a drinker, they added, you should do so with moderation.

Refined grains have been milled so that their outer bran coating has gone, leaving just the endosperm. Examples include white rice, white pasta and white bread. When referring to rice, the term polished is often used with the meaning 'milled'.

Unpolished long-grain rice with bran

Polished Indian sona masuri rice grains

In whole grain products, the germ and endosperm are still there. Bran is a good source of fiber, while the germ has protein, minerals and vitamins - the endosperm has carbohydrates (mainly in the form of starch).

Whole grains, also known as unrefined grains (unrefined carbs) are rich in antioxidants and phytochemicals - these help protect us against diabetes, some cancers and coronary heart disease. Some studies have demonstrated that individuals who consume at least three portions of whole grains each day have a lower risk of developing heart disease compared to people who don't.

Here you can see the bran, germ and endosperm

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

Visit our nutrition / diet section for the latest news on this subject. "Joint association of glycemic load and alcohol intake with type 2 diabetes incidence in women"
Rania A Mekary, Eric B Rimm, Edward Giovannucci, Meir J Stampfer, Walter C Willett, David S Ludwig, and Frank B Hu
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(Hover over the stars then click to rate) posted by sam on 25 Nov 2011 at 7:26 am

Oh yea sure,Keep on Backing UP ALCOHOL USE.....Yea OK

But drink more than the recommended one glass per day and you reverse the heart-healthy benefit.

“Chronic heavy drinking is a leading cause of cardiovascular disease,” Eskapa says.

Excessive drinkers also face:
A higher risk of damaging heart muscle – and that occurs earlier in drinking women than in men
Higher triglyceride (fat) levels in the blood
High blood pressure
Heart failure
Diabetes
Stroke
Cardiac arrhythmia (irregular heartbeats)
Death from heart attacks
Anemia (a shortage of red blood cells, which carry oxygen to the body)

Brain Damage
Women drinkers are more vulnerable to brain damage.

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posted by selenar on 25 Nov 2011 at 11:39 pm

selecting better alcoholic options is important as well. I have heard there are some low calorie vodkas that can be used for cocktails that contain electrolytes and natural flavors

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posted by Branden on 26 Nov 2011 at 2:40 am

Alcohol is not good for you one bit, honestly it's not even worth posting the reasons why...Alcohol is not good in any which shape or form...just do not drink

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Construction Workers And Electricians At High Risk Of Asbestos Exposure

Asbestos exposure is known to cause : Statistics show it is particularly prevalent amongst construction workers and electricians due to their constant contact with construction materials and dust, some of which is likely to include asbestos, no matter how careful they are.

Asbestos, although a natural fiber, when swallowed or inhaled, can cause grave health risks as fibers trapped in the body begin to cause irritation, tumors and especially pulmonary problems. Unfortunately, it was a commonly used construction material in the early half of the 20th century, preferred for its low cost, ease of manufacture, as well as its fire and water resistant properties.

Modern construction no longer uses asbestos due to improvements in synthetic materials and cements and more awareness of the dangers it poses.

Mesothelioma is a type of cancer specific to asbestos exposure. There are no cases of Mesothelioma not associated with Asbestos. It normally occurs in the linings of the lungs (pleural mesothelioma) and abdomen (peritoneal Mesothelioma), but the cancer can occur in the lining of many internal organs. Sadly, Mesothelioma is incurable because it is typically diagnosed late, and, according to the Mayo Clinic, treatment has to be focused on keeping the patient as comfortable as possible.

Mesothelioma can take years to develop, so that a worker who was exposed to asbestos many years ago, may develop it long after retirement. It can take 20 to 40 years to develop, however once diagnosed it is characteristically very aggressive.

Exposure to asbestos may also cause regular lung cancer. Asbestos related lung cancer occurs in the lungs themselves and may result in tumors that reduce pulmonary function and begin to block airways.

Asbestosis, which only occurs from exposure to asbestos, is not a form of cancer, but rather the buildup of scar tissue in the lungs caused by the irritation and damage from the fibres.

Until the 1980s, asbestos was regularly used in construction and other industrial applications. Awareness of problems with asbestos combined with lawsuits against employers and manufacturers put an end to its use.

Asbestos is naturally heat resistant and can provide a useful fireproof layer in products, ranging from flooring and walling to vehicle brakes and insulation, thus many workers were literally in contact with asbestos on an almost daily basis, which is known as "occupational exposure". They are clearly at a much greater risk of developing lung cancer, mesothelioma or asbestosis.

The areas of industry include :
Auto mechanicsBrick and stone masonsConstruction workersElectriciansFirefightersHVAC workers/Boiler MechanicsInsulation InstallersPlumbersRailroad workersRoofersWeldersIn construction asbestos was used in many products, including, but not limited to :
BoilersCeiling tiles DrywallFireproofing materialsFlooringInsulationRoof panels Workers would often cut the asbestos material to fir the installation. Asbestos is most commonly known as a grey fibrous board, similar to compressed cement board. The problem of exposure continues, even though new projects are not using the material any longer, any renovations of pre 1990s buildings can come across large usage of asbestos, the removal of which poses a genuine hazard. Even the World Trade Center Towers, relatively modern buildings, were riddled with asbestos - there are real concerns for firemen and contractors involved with cleaning up the site. Electricians have a dual set of risks, not only in dealing with standard construction materials that they need to cut through or install, but also electrical products themselves which used asbestos. They risk exposure to asbestos almost daily.

When drilling conduits for wiring, electricians often encounter asbestos products in the walling. The drilling itself being one of the worst exposures, producing large amounts of dust that many not be immediately identifiable as asbestos. Some electrical products that include asbestos are : Ceiling tilesCement sidingCircuit BreakersInsulationSwitchgearsThermal paperWall plasterOlder equipment in buildings that electricians may be working on or around, including turbines, generators, heating units, hot water tanks etc. may also have asbestos in their installations. Whilst not being in the most immediately obvious industry for asbestos exposure, electrical workers are besieged from all sides by asbestos risk. Asbestos is a very small fiber that is transmitted in dust and can easily attach to clothing, shoes, hair, skin, collect in work vehicles and be taken back to the home. Thus many family members of workers who were exposed on the job may have been exposed to harmful amounts of asbestos, via transmission of the particles from the work site to the home.

Because of the latency period of developing mesothelioma or other lung diseases caused by asbestos, many workers are still discovering that they have, or are developing, complications due to asbestos exposure.

If you or a family member work, or previously worked, in a job that brought exposure to asbestos, contact a personal injury attorney experienced in handling asbestos related claims.

This articles has been adapted from a press release issued by Gori Julian & Associates on behalf of www.gorijulianlaw.com/

Written by Rupert Shepherd
Copyright: Medical News Today
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New Paper In The Lancet Describes Proof-of-Concept Study Involving Implantation Of Synthetic Tissue-Engineered Windpipe

Tracheal tumors can be surgically removed, but most are too large for the surgery to be successful by the time they are discovered. Therefore, new therapeutic options are needed. Even in patients with operable tumors, the proportion of complete tumor resection is less than 60%. This outcome would be greatly improved if a trachea substitute with similar anatomical, physiological and biomechanical properties of the patient's original trachea were available. A team led by Paolo Macchiarini, MD, PhD, of Karolinska University Hospital and Karolinska Institutet in Stockholm, Sweden, successfully performed this type of procedure on a 36-year-old male patient with tracheal cancer in June 2011.

In November, the Macchiarini team repeated its success: A 30-year-old Baltimore engineer with a cancerous tumor on his trachea, who had been told by American doctors that the tumor was too large to be excised completely, traveled to Sweden for the identical surgery.

Dr. Macchiarini, in collaboration with his research ream, recently published a paper detailing the first of the two surgeries titled "Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study" in the British medical journal The Lancet.

In addition to Dr. Macchiarini, the international team involved Professor Alexander Seifalian from University College London who designed and built the nanocomposite tracheal scaffold, and Harvard Bioscience of Holliston, Massachusetts, which produced a specifically designed, shoebox-sized bioreactor used to seed the scaffold with the patient's own stem cells. The cells were grown on the scaffold inside the bioreactor for approximately two days; the scaffold was rotated while its surface was soaked with stem cells obtained from a bone marrow biopsy from the patient's hip. The patient's stem cells settled into the pores within the scaffold and began to grow into each other, slowly transforming from individual cells into genuine tissue. A few days after the implantation of the new trachea, the man's own blood vessels actually started to grow into it, transforming the new organ into a part of his own body. Because the cells used to regenerate the trachea were the patient's own, there was no rejection of the transplant and the patient is not taking immunosuppressive drugs.

The patient had been suffering from late-stage tracheal cancer. Despite maximum treatment with radiation therapy, the tumor had reached approximately 6 cm in length and was extending to the main bronchus. It was progressing and almost completely blocked the trachea. Since no suitable donor windpipe was available, the transplantation of the synthetic tissue-engineered trachea was performed as the last possible option for the patient, referred by Professor Tomas Gudbjartsson of Landspitali University Hospital (Iceland) who was also part of the surgical team.

The successful transplantation of tissue-engineered synthetic organs, referred to as regenerative medicine, could open new and very promising therapeutic possibilities for the thousands of patients who suffer from tracheal cancer or other conditions that destroy, block or constrict the airway. This procedure is still experimental and will need to be sanctioned by the U.S. Food and Drug Administrations for the more than 100,000 Americans who are actively waiting for organ transplants to benefit from it. "[A] tailor-made synthetic tracheal scaffold is an urgent clinical need," the authors write.

"Transplantations of tissue-engineered windpipes and potentially other tubular organs like esophagus, blood vessels and ureters with synthetic scaffolds in combination with the patient's own stem cells, as a standard procedure, means that patients would not have to wait for a suitable donor organ," said David Green, President of Harvard Bioscience, which produced the bioreactor. "This would be a substantial benefit for patients since they could benefit from earlier surgery and have a greater chance of cure. In addition to treating adult patients, tissue-engineered synthetic trachea transplants would, not least, be of great value for children, since the availability of donor tracheas is much lower than for adult patients."

Article adapted by Medical News Today from original press release. Source: Harvard BioSciences
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