Archives: 8/2007

perivision TrueField® Analyzer Approved by FDA
A new device from Seeing Machines, an Aussie firm, has been given FDA approval to assess issues within the visual field of the eye.

Unlike traditional standard automated perimetry (SAP) devices, the TFA measures both eyes on currently [sic], and does the entire test of both eyes in approximately 5 minutes (including rest breaks within the test). The objectivity of the TFA test offers doctors the possibility of significant improvements over the test-retest variability issues that impact SAP. For patients it means an end to the button pressing associated with SAP – the only task required of the patient in the TFA test is simply to look at the display.
The clearance of the device by the FDA satisfies this regulatory hurdle and allows the TFA to be commercially introduced into the United States market – the largest healthcare market in the world. Receipt of this FDA clearance allows us to remain on track to meet our original objective of launching the TFA in late 2007, and as such the device will be exhibited at the upcoming Annual Meeting of the American Academy of Ophthalmology in New Orleans in November 2007.

More from RNS
Truefield® Analyzer product page

genetransfer Parasitism Taken to New Levels
University of Rochester scientists discovered a bacterial parasite that is capable of inserting almost its entire genome into the genome of the host. This throws another wrench into the evolution debate, as different species are shown to modify the genes of each other, not just within the species due to environmental factors.

How does Wolbachia transfer its genes to other species? When the Wolbachia invades an organism, usually an insect, it eventually reaches the host’s eggs or sperm. Once there, Wolbachia DNA is ensured passage to its host’s offspring. But if the host cells accidentally pick up Wolbachia DNA as they routinely repair their damaged DNA, resulting genetic changes in the host cells may also be passed on to the host’s offspring.
It was the Wolbachia’s known ability to infect its hosts’ reproductive organs together with an earlier discovery by other researchers of a Wolbachia genome incorporated into a beetle genome that initially inspired the research team to screen the genomes of invertebrates for Wolbachia genes. Early in the screening, they found evidence that some Wolbachia genes were fused to the genes of the fly, as if they were part of the same genome.
In an attempt to isolate the fly genes from the Wolbachia genes, the researchers killed all of the Wolbachia in a colony of fruit flies by feeding antibiotics to the flies. Follow-up testing of the fly DNA for Wolbachia DNA revealed, to their dismay, that it still tested positive for Wolbachia DNA. The researchers eventually discovered that they were detecting copies of the parasite’s genome that remained in the fly genome, not the bacteria itself.
The researchers also verified that the Wolbachia genes were inherited like “normal” insect genes in the chromosomes. In addition, they confirmed that some of the genes were “transcribed” in uninfected flies, meaning that they contain copies of the gene sequence that could be used to make Wolbachia proteins.
The discovery of frequent lateral gene transfer has important implications for genome-sequencing projects in which bacterial DNA has typically been discarded as contamination. This study indicates that such discarded bacterial DNA may very well be part of the organism’s genome, and may even carry functioning traits.
The discovery of frequent lateral gene transfer also has important implications for pest and disease control. If, for example, laterally transferred genes become vital to a disease-causing or transmitting host species, the transferred genes could serve as new disease-fighting targets.
In the future, the researchers hope to investigate whether other bacteria besides Wolbachia are engaging in frequent lateral gene transfer.

National Science Foundation Press Release: One Species’ Genome Discovered Inside Another Species’ Genome

SiemensADmamogrophy 5 Megapixel Medical Monitor from Siemens
Siemens has announced its introducing a new computer monitor for medical applications that features an impressive 5 megapixel resolution, precision contrast, and other features important to the medical imaging community.

The high-resolution monitor has 2048 x 2560 pixels and a luminance of 750 cd/m2 (candelas per square meter). Two independently functional sensors are used to continuously monitor the luminance and grayscale levels. The “Integrated Stability Sensor” (ISS) monitors the backlight at the center of the display while the “Integrated Consistency Sensor” (ICS) reviews performance on the front right corner without obstructing the user’s view of the display. This redundant monitoring system ensures consistently high image quality and conformance with medical imaging standards such as Dicom (Digital Imaging and Communications in Medicine). The blue tinted CCFL (Cold Cathode Fluorescent Lamp) backlight is optimally suited to the human visual system, which is especially sensitive to light in this color range. This enables diagnoses with maximum sharpness and minimum eye fatigue.

Press Release: 5 megapixel monochrome display for mammography diagnosis

456534mic Supersize My Mouse
Se-Jin Lee, MD, PhD and colleagues at the Department of Molecular Biology and Genetics at Hopkins are creating stronger and meaner looking mice, by targeting genes in specific signaling pathways. At one point, we think, these engineered beasts will be ready to defend democracy from enemies foreign and domestic:

The Johns Hopkins scientist who first showed that the absence of the protein myostatin leads to oversized muscles in mice and men has now found a second protein, follistatin, whose overproduction in mice lacking myostatin doubles the muscle-building effect.
Results of Se-Jin Lee’s new study, appearing this Wednesday in PloS One, show that while mice that lack the gene that makes myostatin have roughly twice the amount of body muscle as normal, mice without myostatin that also overproduce follistatin have about four times as much muscle as normal mice.
Lee, M.D., Ph.D., a professor of molecular biology and genetics, says that this added muscle increase could significantly boost research efforts to “beef up” livestock or promote muscle growth in patients with muscular dystrophy and other wasting diseases.
Specifically, Lee first discovered that follistatin was capable of blocking myostatin activity in muscle cells grown under lab conditions. When he gave it to normal mice, the rodents bulked up, just as would happen if the myostatin gene in these animals was turned off.
He then genetically engineered a mouse that both lacked myostatin and made extra follistatin. If follistatin was increasing muscle growth solely by blocking myostatin, then Lee surmised that follistatin would have no added effect in the absence of myostatin.
“To my surprise and delight, there was an additive effect,” said Lee, who notes these muscular mice averaged a 117 percent increase in muscle fiber size and a 73 percent increase in total muscle fibers compared to normal mice.
“These findings show that the capacity for increasing muscle growth by targeting these pathways is much more extensive than we have appreciated,” adds Lee. “Now we’ll search for other players that cooperate with myostatin, so we can tap the full potential for enhancing muscle growth for clinical applications.”
Lee adds that this issue is of particular significance, as most agents targeting this pathway, including one drug being currently tested in a muscular dystrophy clinical trial, have been designed to block only myostatin and not other related proteins.

Press release from Johns Hopkins: “MIGHTY MICE” MADE MIGHTIER …
PLoS One paper: Quadrupling Muscle Mass in Mice by Targeting TGF-β Signaling Pathways

Exubera Exubera, Pfizers Insulin Spray OrdealBad news for the insulin spray gun, as sales are not meeting expectations.

Analysts were forecasting blockbuster annual sales of $2bn (£1.01bn, E1.49bn) for the insulin spray. It delivered just $4m in the second quarter of 2007 – the first time Pfizer disclosed sales of the product.
In July, Pfizer launched a massive television and print ad campaign in the US to jump-start sales. Reducing the number of inhalers produced is a clear indication management are unsure their next campaign will have much impact on sales.
The cutbacks are spelt out in a report filed with the US Securities and Exchange Commission by West Pharmaceutical Services, the American drug technology firm that makes about 60% of the device.
It said: “We expect Pfizer’s high inventory levels and slower-than-expected demand will affect our fourth-quarter 2007 and full-year 2008 sales levels. In coordination with our customer, Nektar, we have reduced production to one shift per day at our dedicated facility beginning in the third quarter of 2007.”

Perhaps the diabetics feel self conscious pulling out what looks like a bong in the middle of a restaurant, and taking a hit.
More from The Business
Exubera website …
(via KevinMD, and PharmaGossip)

redprotein20070826 287 New Fluorescent Protein for Medical Imaging Found in FishtankAn interesting development that comes from an unusual source, may soon help doctors see all those tumors much more clearly.

The development of the red fluorescent protein, which the researchers call Katushka, was reported by Howard Hughes Medical Institute international research scholars Andrey Zaraisky, Sergey A. Lukyanov, and their colleagues August 26, 2007, in the online version of Nature Methods. Principal development of Katushka was carried out by Dmitry Chudakov and colleagues in Lukyanov’s laboratory at the Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry in Moscow. Zaraisky and his colleagues are also at the institute.
According to the researchers, Katushka solves a major problem in the field of fluorescent reporter proteins. Fluorescent proteins have become invaluable research tools for labeling specific genes and tissues. This labeling permits researchers to follow gene activity visually or to track cellular development. However, there is no tracer that glows brightly in a particular “window” of the far-red spectrum favorable for maximally penetrating living tissues. Thus, such proteins were not practical for optically imaging tagged genes, cells or tissues in whole animals.
The development of Katushka might never have happened had it not been for the shrewd bargaining of Lukyanov. Visiting a Moscow pet shop, Lukyanov saw a brilliant red sea anemone among the denizens of the store’s aquarium. Sensing that the vivid red coloring in the anemone might provide the blueprint for a new biological tracer, he tried to buy the anemone. He was told by the shopkeeper that it had already been sold, and the buyer was expected shortly. Unfazed, Lukyanov persistently outbid the buyer and procured the creature.
Back in Lukyanov’s laboratory, Chudakov and his coworkers isolated the red protein from the anemone and then developed an enhanced version, which they named turbo red fluorescent protein (TurboRFP). The protein comprised a string of identical protein subunits, so the researchers also developed a single-unit monomeric version, which they called TagRFP.
Although TurboRFP was twice as bright as a comparable red protein, DsRed2, the researcher set out to improve its brightness in the far-red window. They created about 100,000 variants of the gene for TurboRFP, screening the resulting proteins for high brightness in the near-infrared. This screening yielded a highly bright variant protein, which they further optimized by randomly mutating the gene and selecting the brightest protein. They named this protein Katushka, a Russian diminutive for the name Ekaterina – after co-author Ekaterina Merzlyak, in recognition of her work developing TurboRFP and TagRFP. Katushka proved to be up to 10-fold brighter in the far-red, compared to the spectrally close fluorescent proteins HcRed and mPlum. mPlum was developed in 2004 by HHMI investigator Roger Y. Tsien at the University of California, San Diego, a leader in the study of fluorescent proteins for cell biology research. The researchers also generated a monomeric version of Katushka, called mKate, which is useful for molecular labeling of proteins.

Howard Hughes Medical Institute: New Red Fluorescent Protein a Glowing Success …
Image Caption: “Transgenic 2.5 month old Xenopus laevis expressing Katushka (left) and DsRed-Express (right) under the control of muscle actin promoter. The frogs are shown from the dorsal side under white light.”

300px Human embryonic stem cell colony phase Store Stem Cells from Excess IVF EmbryosStemLifeLine, a California firm, plans to offer the ability to collect and store stem cells from excess embryos that occur during IVF procedures. The MIT Technology Review has the story:

The new service is meant to take advantage of a growing interest in the field of regenerative medicine. Stem cells from adult blood or umbilical-cord blood are already used to treat some diseases, including sickle-cell anemia and several forms of leukemia. But these cells are largely limited to treating blood-related disorders and can’t be grown in large numbers. Embryonic stem cells, on the other hand, can be coaxed to form virtually any type of cell in the body and can theoretically be replicated indefinitely. Scientists are developing ways to use them to replenish cells lost or damaged in ailments such as diabetes, Parkinson’s disease, and heart disease. But as of now, those treatments are limited to the lab: no embryonic stem-cell-based therapies are approved for human use.
Couples who have had children via IVF are often left with extra embryos–and the rather difficult decision of what to do with them. As of 2003, an estimated 400,000 embryos remained in cryopreservation in the United States. Embryos can be donated to research or to other couples, destroyed, or left languishing in frozen storage. According to Ana Krtolica, StemLifeLine’s CEO, the inspiration to form the company came from requests from clients at IVF clinics who were donating their embryos to research but wanted to know if they would have access to those cells if they were ever needed. (The answer is no.)

More details at the MIT Tech Review
StemLifeLine home page

heartmateII HeartMate II Shown Effective In Waiting Transplant Candidates
A study conducted by a team from the University of Michigan and cardiologists from the Washington Hospital Center has shown that the HeartMate II from Thoratec increases life expectancy for those waiting for a new heart.

The new study included 133 patients, and assessed the device’s ability to support patients for six months, or until they received a transplant or recovered heart function, whichever came first. The researchers assessed patients’ functional heart status, as measured by their class of heart failure severity and their ability to walk for six minutes, as well as kidney (renal) and liver (hepatic) function, which are usually diminished by the decreased blood flow from a heart failure patient’s heart. The patients’ quality of life was measured using two standard questionnaires that assess everything from patients’ ability to enjoy social activities, to their physical day-to-day symptoms and mental health.
Three-quarters of the study participants were men, with an average age of 50. Two-thirds of the patients had heart failure not related to an ischemic cause such as a heart attack – and all were in the most severe stage of heart failure, called class IV. Many had already received other heart-assisting technologies including pacemakers and implanted defibrillators to regulate their heartbeats; 41 percent had pre-surgery help from an intraaortic balloon pump.
In all, 100 of the patients had successful outcomes by the end of six months, with 56 receiving transplants, 43 remaining on the device and one recovering enough to allow the device to be removed. But the 25 deaths in the study before six months, including 18 patients who died before leaving the hospital, show that serious complications do occur even with the newer generation of device due to the acuity of illness of these patients. Many patients experienced bleeding related to blood-thinning drugs used with the device.
But nearly all patients experience cardiac recovery so significant that by the end of three months they were moved to a less-severe stage of heart failure. There were significant improvements in quality of life scores and liver and kidney function.

Press release: U-M study: Device helps heart transplant candidates survive & regain heart function while they wait for donor
Flashbacks: HeartMate® II Left Ventricular Assist System, Canadian Receives HeartMate II Non-Pulsatile LVAD, Eh?

The NIH is funding a study to adapt a “non-invasive radiometric-sensing device” from Meridian Medical Systems of Woolwich, ME, in order to measure the temperature of newborns’ brains that have to undergo a brain cooling technique which prevents damage in cases of low oxygen levels.

A neonatologist at Children’s Hospital of The King’s Daughters (CHKD) is leading the clinical trials of a $750,000 study funded Friday, Aug. 31, to develop a device to measure the precise temperature of a newborn’s brain.
The National Institutes of Health (NIH) grant stems from recent studies showing that cooling of the brain of oxygen-starved newborns dramatically reduces the incidence of Cerebral Palsy, other neurological damage, and death.
While recent studies have demonstrated the effectiveness of the brain-cooling regimen, doctors don’t yet have a precise way to measure the brain’s temperature. The NIH grant will allow researchers to adapt a non-invasive radiometric-sensing device — developed by Meridian Medical Systems of Woolwich, ME — to provide precise temperatures of brain tissue beneath the skull…
Under the NIH grant, Bass, Meridian and a team of EVMS research scientists will exploit the fact that all human tissue emits energy at microwave frequencies. Those emissions can travel through tissue, but only for a few millimeters, depending on the frequency. As the tissue’s temperature rises, emissions increase.
By tabulating the frequency and strength of electromagnetic emissions emanating from the body, Meridian has developed a device that can measure the temperature of tissue a given distance below the skin’s surface, even through a baby’s skull.
The research team hopes to use this technology to develop a small, lightweight device that can be affixed to an infant’s head to detect electromagnetic emissions generated 15 millimeters below the surface, giving doctors the exact temperature of the child’s brain.

Press Release: NIH grants $750,000 to develop device to determine temperature of neonate’s brain