The trial will include 412 patients at 12 large medical centers in the US as well as at Hadassah Medical Organization in Jerusalem. Exalenz says that it believes that this is the largest clinical trial of its kind ever conducted by an Israeli company. The trial aims at replicating the results of the Phase II clinical trial in Israel and Europe, which was completed a few months ago.

Here's a video overview of the BreathID system:

Press release: FDA approves Exalenz Liver Trial (.pdf)...

BreathID technology page...

The Magnetic Resonance working group at the Fraunhofer Institute for Biomedical Technology Engineering IBMT in Sankt Ingbert has made magnetic resonance imaging mobile. They collaborated with the New Zealand company Magritek to develop small portable devices. Dr. Frank Volke, head of the Magnetic Resonance working group, explains the core technology: "Instead of the large superconducting magnets that have to be cooled with liquid helium and nitrogen, extra-strong permanent magnets are installed in our devices. There is no need for cooling anymore." To make this possible, several permanent magnets are so arranged that the magnetic field lines overlap to form a homogeneous field. In this way, the developers have succeeded in developing small, less expensive, and above all portable magnetic resonance spectrometers that can even be powered by batteries.

Press release: Pocket-sized magnetic resonance imaging ...

Magritek technology page...

The biosensor device works to painlessly remove this outer-dermis, or dead-skin layer, by using a “micro-hotplate” (or micro-heater), which measures about 50 microns square and is carefully controlled to apply a small amount of power. (To imagine how small this area is, note that the period at the end of this sentence is about 10 times larger than the hotplate). For 30 milliseconds (that’s 30 one-thousandths of a second) the “hotplate” is turned on to a temperature of 130 C. Sounds hot, but in such a small spot, and for such a short time, a person cannot even detect the heat, or feel any pain, as it is applied to the outer layers of skin.

This hotplate causes a tiny micro-pore to form through which a little bubble of fluid passively emerges. The bio-sensor then reads the glucose levels in the sample fluid through tiny electrodes coated with a substance that reacts specifically to the glucose.

The bio-sensor project initially began through funding from the military, with the intention of developing a miniature device to remotely monitor the health status of soldiers in a battlefield. This tiny prototype chip, which acts as a patch on the skin and is called the B-FIT (Bio-Flips Integrable Transdermal MicroSystem), can obtain samples of fluid from under the skin one time every hour for a 24-hour period.

To support the design and development of the device, Currie and Paranjape received a Department of Defense contract for $3 million over 3 years from DARPA (Defense Advanced Research Projects Agency).

Full story at Georgetown: Monitoring Diabetes Without Pain and Blood: Biosensors Offer New Alternatives ...

The heart of the Microvisk system is a micro sensor that is less than a millimetre in size. The sensor is created using a microscopic cantilever device, which bends when heated. The degree and the speed at which the cantilever device bends is indicative of the thickness of the blood surrounding the sensor. A hand held measuring instrument provides an immediate read-out of results which can be downloaded directly onto a computer. These miniature devices are cheap to manufacture in large quantities and are therefore disposable. Unlike other conventional sensors, the measurements can be made with a very small blood sample, causing less pain and tissue damage to the patient.

John Curtis, Chief Executive at Microvisk said: “Medical diagnostics is rapidly moving towards more effective and immediate testing for patients and away from the traditional, lengthy processes of sampling at a doctor's surgery and getting the results back from a lab weeks later. Microvisk's revolutionary new technology provides instant testing and analysis to measure blood clotting, using just a pin prick of blood. This is an easier, quicker and less intrusive approach to measure whether a patient is receiving the correct treatment dosage. The market for testing patients on Warfarin is huge, with a global value at over $2.25bn.”

UK Science & Technology Facilities Council press release: Immediate blood clotting analysis - at the doctor's surgery ...

Top image: Electron microscope image of the microfabricated cantilever device. Side image: Abstract top-view visualization of the device.

(hat tip: The Engineer Online)

It consists of a smooth surface that is studded with 250,000 tiny plastic columns measuring only five microns in diameter, rather like a fakir’s bed of nails. These columns are made of elastic polyurethane plastic. When a cell glides across them, it bends them very slightly sideways. This deflection is registered by a digital camera and analyzed by a special software program. The researchers working with project manager Dr. Norbert Danz of the Fraunhofer Institute for Applied Optics and Precision Engineering IOF in Jena have already shown that their ‘Cellforce’ sensor works. It will be the task of initial biological tests to show how different cell types behave. “Analysis of cell locomotion is important for numerous applications,” says Danz. “It could be used to check whether bone cells are successfully populating an implant, or how well a wound is healing.”

Developing the sensor was no easy undertaking. For one thing, the columns have to be coated in such a way that living cells are happy to move across their tips. The cells would otherwise avoid the tips and continue their journey lower down between the columns. In that case, there would be no deflection at all. Danz had the task of adapting the microscope required for cell magnification to make it exactly right for the application. Building the delicate column structure developed by researchers at the Fraunhofer Institute for Manufacturing Engineering and Applied Materials Research IFAM in Bremen is no less tricky: The researchers press liquid plastic at a pressure of 2000 bar into a negative mold and allow it to harden. It is a challenge even to manufacture the required mold, with its 250,000 micron-sized holes. To allow cost-effective production of the ‘Cellforce’ sensor in future, the researchers utilize commercially available plastics and well-established techniques from chip manufacture. The first ‘Cellforce’ prototype is expected to be ready in a year’s time.

Press release: Measuring the footprint of cells ...

Project info page: Development of a single cell based biosensor for subcellular on-line monitoring of cell performance for diagnosis and healthcare...

Here's what The Engineer says about the technology:

The patented system combines microfluidic lab-on-a-chip technology with light-emitting polymers (LEPs) and photodetectors to carry out a battery of medical tests simultaneously. The chip incorporates up to 10 channels, allowing the level of multiple analytes to be measured simultaneously alongside internal controls and reference samples. It does this by measuring absorbance, fluorescence, chemiluminescence and phosphorescence.

Ian Campbell, Molecular Vision's chief executive, said: 'Essentially we have an organic polymer that can be deposited on both the top and bottom sides of the microfluidics. The top polymer acts as a light-emitting diode, so when a current in the slide passes through the polymer it lights up. The polymer at the bottom acts as a photon receiver and translates the signal from light to amps. The amount of signal it receives is proportional to the amount of active material in the sample, which can then be displayed on a readout.'

Results are output within minutes and can be displayed on a LCD screen on the device, or via a PDA, mobile phone or home computer. Each could also be used to power the device, which can also run on a small internal 'button' battery.

The sample body fluid will be mixed with reagents through the microfluidic network. Sample pre-treatment, chemical reactions, analytical separations and detection are all carried out on a single chip. The system is low risk as it uses established assay technology and reagents.

To check out more about Molecular Vision technology, head on to company's website...

Full story from the Engineer: Doctor on a chip...

From a NASA statement:

This biosensor will be used to help prevent the spread of potentially deadly biohazards in water, food and other contaminated sources.

NASA's Ames Research Center at Moffett Field in California licensed the biosensor technology to Early Warning Inc., Troy, N.Y. Under a Reimbursable Space Act Agreement, NASA and Early Warning jointly will develop biosensor enhancements. Initially, the biosensor will be configured to detect the presence of common and rare strains of microorganisms associated with water-borne illnesses and fatalities.

"The biosensor makes use of ultra-sensitive carbon nanotubes which can detect biohazards at very low levels," explained Meyya Meyyappan, chief scientist for exploration technology and former director of the Center for Nanotechnology at Ames. "When biohazards are present, the biosensor generates an electrical signal, which is used to determine the presence and concentration levels of specific micro-organisms in the sample. Because of their tiny size, millions of nanotubes can fit on a single biosensor chip."

Early Warning company officials say food and beverage companies, water agencies, industrial plants, hospitals and airlines could use the biosensor to prevent outbreaks of illnesses caused by pathogens - without needing a laboratory or technicians.

"Biohazard outbreaks from pathogens and infectious diseases occur every day in the U.S. and throughout the world," said Neil Gordon, president of Early Warning. "The key to preventing major outbreaks is frequent and comprehensive testing for each suspected pathogen, as most occurrences of pathogens are not detected until after people get sick or die. Biohazards can enter the water supply and food chain from a number of sources which are very difficult to uncover."

Early Warning expects to launch its water-testing products in late 2008.

NASA press release: NASA Nanotechnology-Based Biosensor Helps Detect Biohazards...

Read: Probing biomolecular interactions with single plasmonic nanoparticles...

Abstract: Protein--Membrane Interaction Probed by Single Plasmonic Nanoparticles ASAP Nano Lett., ASAP Article, 10.1021/nl080805l

A pinprick of blood or drop of urine soaked up at the edge of the Whitesides device moves naturally through the paper, in much the way that wine will spread through a paper napkin. But the paper is treated with a hydrophobic polymer, which directs the liquid along prescribed channels. Once the liquid reaches the wells at the ends of the channels, it interacts with reagents, turning the paper different colors. The colors can be matched to those on a color key, much as they are in a pH test. One test design that looks like a miniature, three-branched, geometric tree might have wells at the end of two branches for a glucose assay and one at the end of the third for a protein assay, for example.

The design dispenses with expensive components common in conventional microfluidic devices: chemical reactions that color parts of the paper replace sophisticated sensors and analyzers, while using paper's natural capillary action to absorb liquids avoids the need for external pumps or power sources. Diagnostics for All--a spinoff cofounded by Whitesides and Harvard visiting scholar Hayat Sindi, with the support of partners from MIT--is commercializing the technology.

Instead of etching channels into a material, as most microfluidics designers do, Whitesides and Sindi were able to take advantage of the network of channels inherent in paper; the hydrophobic polymer simply seals off the channels that the researchers don't want to use. "What's really clever about this system is that they've actually patterned the whole volume of the substrate," Folch explains. "The paper itself forms a network of capillaries."

More at MIT Tech Review...

“Many heart attack victims, especially women, experience nonspecific symptoms and secure medical help too late after permanent damage to the cardiac tissue has occurred,” says John T. McDevitt, principal investigator and designer of the nano-bio-chip. “Our tests promise to dramatically improve the accuracy and speed of cardiac diagnosis.”

McDevitt, a professor of chemistry and biochemistry at The University of Texas at Austin, collaborated with scientists and clinicians at the University of Kentucky, University of Louisville, and The University of Texas Health Science Center at San Antonio...

McDevitt and his co-workers and collaborators took advantage of the recent identification of a number of blood serum proteins that are significant contributors to, and thus indicators of, cardiac disease.

Leveraging microelectronics components and microfabrication developed initially for the electronic industry, the research group developed a series of compact nano-bio-chip sensor devices that are biochemically-programmed to detect sets of these proteins in saliva. They looked at 32 proteins currently used for diagnosis of blood serum in cardiac clinical practice.

The new diagnostic test works like this: A patient spits into a tube and the saliva is then transferred to a credit card-sized lab card that holds the nano-bio-chip. The loaded card is inserted like an ATM card into an analyzer that manipulates the sample and analyses the patient’s cardiac status on the spot.

The test can reveal that a patient is currently having a heart attack and that they should receive treatment quickly. It can also tell a patient that they are at high risk of having a future heart attack.

The researchers have currently measured 80 clinical patients and their data shows that the saliva tests were nearly equivalent to more standard tests on blood serum using FDA-approved instruments.

“What’s novel here is our ability to measure all such proteins in one setting and to use a noninvasive saliva sample, where low protein levels make such tests difficult even with large and expensive lab instruments,” McDevitt says.

The new technology is still in the clinical testing phase, but it is a strong candidate for further commercial development through the Austin, Texas company LabNow, Inc., a start-up venture that licensed the lab-on-a-chip technologies from The University of Texas at Austin. LabNow’s first lab-on-a-chip product, now in development, targets HIV immune function testing and can be used in resource poor settings like Africa.

Press release: Saliva Can Help Diagnose Heart Attack, Study Shows...

More: McDevitt Research Labs - Lab-on-a-Chip Sensors...

Flashback: Sampling Saliva for Breast Cancer at The Dentist's

(hat tip: Technology Review)