On its front page, the New York Times (8/10, A1, Belluck, Subscription Publication) reports that according to a study published in the Journal of the American Medical Association, "a simple blood test that can determine a baby's sex as early as seven weeks into pregnancy is highly accurate if used correctly." Experts predict that "parents concerned about gender-linked diseases, those who are merely curious, and people considering the more ethically controversial step of selecting the sex of their children" are all likely to utilize this technology. The Times says similar tests have previously been commercially available but were often inaccurate. In response to concerns of gender selection, some companies require waivers from customers saying they will not use the test for that purpose.

USA Today (8/10, Szabo) reports, "The technology works by detecting 'cell-free fetal DNA,' or DNA from the fetus, which floats freely in a pregnant woman's blood." USA Today also notes specific concerns about possible misuse of the technology, citing a study in The Lancet estimating that "between 4.2 million and 12.1 million female fetuses were 'selectively' aborted in India from 1980 to 2010, a practice that is noticeably skewing the ratio of boys and girls in that country."

The AP (8/10, Tanner) specifies that the procedure tested in this study uses a PCR test for Y chromosome DNA to tell whether the fetus is biologically male or female. AP notes that testing was performed in research settings, while "tests that companies sell directly to consumers were not examined in the analysis." Researchers stated that "blood tests like those studied could be a breakthrough for women at risk of having babies with certain diseases, who could avoid invasive procedures if they learned their fetus was a gender not affected by those illnesses."

The Los Angeles Times (8/9, Khan) "Booster Shots" blog reported, "The researchers found that tests...are about 95% to 99% accurate, depending on several factors. They can be used well before ultrasound...and aren't invasive, unlike amniocentesis, which carries a small but real risk of miscarriage." However, science writer Karen Kaplan warns that "There's a whole industry of questionable genetic tests put out by 'entrepreneurs' that promise to tell parents-to-be practically anything about their future children, from ethnic heritage to most viable future sports activities."

The Wall Street Journal (8/9, Hobson, Subscription Publication) "Health Blog" noted that some diseases, such as congenital adrenal hyperplasia, require corticosteroid treatment of the mother throughout her pregnancy if the fetus is female. Therefore, the test would find that a woman carrying a female child with this condition should be treated, while a woman carrying a male child with the condition could avoid such treatment.

According to the Boston Globe (8/9, Kotz) "Daily Dose" blog, currently available tests in the US are unregulated by the US Food and Drug Administration. Notably, "Several years ago, Lowell-based Acu-Gen Laboratories promised that its Baby Gender Mentor blood test was '99.9 percent accurate' in detecting a fetus's sex at five weeks and offered refunds to anyone who received wrong results. The company was forced into bankruptcy in 2009 after hundreds of women with false results filed class action lawsuits after they said they weren't given any refunds." The researchers who published this study said the Acu-Gen test detected the "Y chromosome only 41 percent of the time." 

In a commentary for MSNBC (8/9), University of Pennsylvania Center for Bioethics director Arthur Caplan wrote that outside of testing for sex-linked genetic diseases, "everything about the early testing of fetal genes for sex identification spells ethical trouble." Caplan predicted these tests will soon be used for gender-selective abortion, paternity testing, and whether "your 7-week-old fetus is prone to early onset breast, colon or ovarian cancer, Down syndrome, cystic fibrosis, sickle cell disease, dwarfism, deafness, Alzheimer's." Caplan argued this test "promises to soon be a very morally contentious technology." 

MedPage Today (8/9, Fiore) reported, "In a review and meta-analysis, detection of Y-chromosome sequences had a sensitivity of about 95% and a specificity of nearly 99%, Stephanie Devaney, PhD, of the National Institutes of Health in Bethesda, Md., and colleagues reported." Researchers stated "that a disadvantage of fetal DNA blood testing is the need to validate female sex, because the test looks for male, or Y-chromosome, DNA." MedPage Today also noted that the National Human Genome Research Institute funded the study.

10 August 2011 -- Fenway, MA. After many years of anticipation, a killer application has finally been discovered for digital pathology, by researchers at the Fenway University in Boston, Massachussetts. "One would think that simply being able to work from anywhere, share anything, with a full audit trail of what was viewed, and the ability for the computer to assist in scoring would be enough to drive digital pathology adoption," said Dr. Mark Lowell, Professor at Fenway University. "However, the industry has been waiting for a killer application to drive adoption, and we believe we have finally found it."

"We studied pathologist patterns while at the microscope and while traveling to peer reviews, conferences, and tumor boards, and we were struck by an amazing pattern. Pathologists that regularly flew through Newark Airport, were far more likely to go digital in their work than those that did not fly through this airport. Basically, we modified an advanced pattern recognition software that was previously only used in over-training results in gene expression datasets, and applied this to pathologist commuting patterns. The trend was consistent everywhere in the United States, the more a pathologist has to travel through Newark Airport, the more likely he or she will stay home and read slides digitally." 

"These results fit well with other evidence we examined in our algorithm," said Dr. Karlton Phisk, a co-author in the study. "First, a ranking of airports has Newark rated first for the most delays. Second, we noticed that pharmaceutical pathologists seem to be adopting digital slides faster than clinical anatomic pathologists, and we can attribute this directly to them having to fly more frequently through Newark for corporate pharma meetings. Third, the Cambridge area of Boston is adopting digital pathology faster than other parts of the United States. Clearly Boston pathologists hate having to travel through the New York area more than other pathologists would, given the historic rivalry between these two cities."

"Saving even one trip through Newark is well worth the purchase of multiple scanners," said Dr. Karl Yastemsky, a third author on the study. "Actually, avoiding New York City for any reason is worth spending a few additional seconds to view the images digitally versus with glass." 

The results are not without controversy, on both sides of the Atlantic. In the United States, Professor R. Ruffen of Yanqui University in New York City strongly disagreed with the study's conclusions. "First, scientists in Cambridge will buy anything, and second, Newark is a beautiful airport.  You can see all of New York City multiple times while circling the airport on most flights. If we applied the logic used in this study, we would expect to see British pathologists also adopting whole slide imaging faster than their peers, because Heathrow Airport is one of the worst to fly through." 

The study's original authors disagreed with Dr. Ruffen's logic challenge comparing Heathrow to Newark. "Everyone knows that British pathologists will take every chance they can get to travel, in hopes of escaping bad food and bad weather, so the effect of Heathrow is a net neutral effect," said Mr. Jon Riddeck, a up and coming star and graduate student at Fenway University, and the fourth author on the study. "Although to be fair, the British breakfasts are quite good, but probably not enough to keep pathologists from traveling abroad" he added.

At a recent pathology meeting, several English pathologists first apologized for their Heathrow Airport as well as their weather and their food, but then asked why they were included in this controversy, that seemed entirely American in nature and had nothing to do with them.

Submitted anonymously to avoid reprisals from anyone and everyone

One of the characteristic features of a chronic colitis is abnormal glandular branching.  Often times the glands take on peculiar shapes that resemble other things, in this case, an animal.  Is it me or does this resemble a bear?

Last month it was announced that Mayo Medical Laboratories entered into a pathology testing agreement with a Chinese medical laboratory.  Earlier this year both UCLA and UPMC announced telepathology initiatives with China.  Now comes word that Leica has entered into collaborative efforts for joint sales, research and development with a Chinese company:

Beijing, China / Wetzlar, Germany. China Medical Technologies, Inc. (CMED) (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic (“IVD”) company, and Leica Biosystems, a division of Leica Microsystems, a world leader in microscopes and scientific instruments, today announced that they have established a sales, research and development collaboration to co-develop and market automated FISH kits to be used on the Leica BOND system. CMED will sell the Automated FISH Kits in China and Leica will have an option to sell the FISH kits in the rest of the world.

 Under the collaboration, CMED and Leica Microsystems will jointly develop automated FISH solutions for tissue sample tests on HER-2, EGFR and TOP2A on the Leica BOND system, an automated advanced staining platform. HER-2, EGFR and TOP2A are genes in connection with the targeted cancer therapy drugs for breast cancer, lung cancer and stomach cancer patients. Automation of these FISH tests on the Leica BOND system will enable pathology laboratories and independent service laboratories to run these diagnostic tests more efficiently and with higher and more consistent quality. The automation of FISH tests will also help users to reduce the work load pressure created by increasing test volumes. Both parties agreed to add further FISH applications into the collaboration during the term, including for cytology and pre-natal applications.

“These collaborations with Leica mark a significant milestone for us,” commented Mr. Xiaodong Wu, Chairman and Chief Executive Officer of CMED. “We believe that FISH applications will be more widely used in various clinical applications on automated basis in the future. By partnering with Leica, one of the leading global players anatomic pathology, we can provide more efficient and higher quality FISH diagnostic solutions to the end users not only in China, but also in the global markets through Leica’s extensive global network.”

“CMED is the market leader for FISH based diagnostics in China and has played a key role in the rapid development in the use of FISH in China, especially for tissue based companion diagnostic testing. This partnership will help Leica and CMED to offer customers in China a broad test menu of high quality FISH tests automated on the Leica BOND system,” commented Arnd Kaldowski, President of Leica Biosystems.

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Leica Microsystems is a world leader in microscopes and scientific instruments. Founded as a family business in the nineteenth century, the company’s history was marked by unparalleled innovation on its way to becoming a global enterprise. Its historically close cooperation with the scientific community is the key to Leica Microsystems’ tradition of innovation, which draws on users’ ideas and creates solutions tailored to their requirements. At the global level, Leica Microsystems is organized in four divisions, all of which are among the leaders in their respective fields: the Life Science Division, Industry Division, Biosystems Division and Medical Division.

Leica Microsystems’ Biosystems Division, also known as Leica Biosystems, offers histopathology laboratories the most extensive product range with appropriate products for each work step in histology and for a high level of productivity in the working processes of the entire laboratory.

The company is represented in over 100 countries with 12 manufacturing facilities in 7 countries, sales and service organizations in 19 countries and an international network of dealers. The company is headquartered in Wetzlar, Germany.

China Medical Technologies, Inc. is a leading China-based advanced IVD company using molecular diagnostic technologies including Fluorescent in situ Hybridization (FISH) and Surface Plasmon Resonance (SPR) and an immunodiagnostic technology, Enhanced Chemiluminescence Immunoassay (ECLIA), to develop, manufacture and distribute diagnostic products used for the detection of various cancers, diseases and disorders as well as companion diagnostic tests for targeted cancer drugs. The Company generates all of its revenues in China through the sale of diagnostic consumables including FISH probes, SPR-based DNA chips and ECLIA reagent kits to hospitals which are recurring users of the consumables for their patients. The Company sells FISH probes and SPR chips to large hospitals through its direct sales force and ECLIA reagent kits to small and mid-size hospitals through distributors. For more information, please visit http://www.chinameditech.com.

The VS120 virtual microscopy slide scanning system from Olympus scans faster than ever before, offers image deconvolution/deblurring for ultra-sharp images and provides important fluorescence imaging capabilities. Virtual slide creation could not be simpler—just set the slide in place and press Start. The system creates outstanding brightfield slide scans up to three times faster than was possible with earlier systems, making it ideal for training, education, archiving and research.

The VS120 is the latest in a series of Olympus virtual microscopy systems that can scan up to 100 slides at a time at very high fidelity, so that users anywhere in the world can view and fully navigate high-resolution images of entire microscope slides or slide areas using a computer. It comes equipped with a 5-megapixel CCD brightfield camera that improves brightfield scanning speeds while delivering superb color reproduction and ultra-high resolution.

Olympus is a world leader in fluorescence microscopy, and no other virtual microscopy system available today can match the fluorescence slide scanning performance of the VS120.

Acquiring sharp images at multiple depths using six or more fluorescence labels is possible, thanks to OlympusFluorescence Virtual-Z capability. The software adjusts for the potentially different focal positions of various wavelengths in multichannel acquisition. Automated batch scanning can be accommodated with fluorescence samples and individual shading correction isavailable for each color channel. In addition, the VS120 provides for online deblurring during fluorescence acquisition, which vastly improves image sharpness in real time.

“The VS120 provides users with the exceptional optical performance and reliability people have come to expect from Olympus, which is renowned for both research microscopy and pathology imaging,” said Brad Burklow, director of business development for the Olympus America Scientific Equipment Group.

In addition to its faster scan speeds, the system offers more than 30 software enhancements. No-neighbor and nearest-neighbor deconvolution are available offline and a wide range of measurement and annotation functions are supported. Images can now be saved in .tiff and .btf file formats, along with the .vsi virtual slide file format. To support users working simultaneously with images from the Nanozoomer virtual microscopy scanning system, the .ndpi file format is supported.

The VS120 is built around the Olympus renowned optical and microscope technologies. For superior optical performance and scanning flexibility, Olympus Plan Apo 2x, 10x, 20x and 40x objectives come as standard, with optional 60x and 100x Plan Apo oil objectives for high-magnification oil immersion scanning.

Source: Olympus America Inc.

Read more at Olympus Virtual Microscopy site.