Keeping you up-to-date on recent headlines in diagnostics.

Daktari gets $2.5M financing ... Daktari Diagnostics (Arlington, Massachusetts) a company focused on global health diagnostics, reported that it has received $2.5 million of a planned $2.9 million equity financing, according to a federal regulatory filing. Daktari develops a handheld CD4 cell counter intended as an easy-to-use blood test. The device uses two technology developments to simplify blood testing: microfluidic cell chromatography and lysate impedance spectroscopy. The handheld device essentially captures "only the few hundred CD4 cells of interest" and measures their contents, offering the CD4 count in six minutes, Daktari said on its web site. The company was co-founded in 2008 by William Rodriguez and Mehmet Toner. In 2007, Mass High Tech reported that Toner was one of two New England researchers to have won $3.4 million in a grant from the National Science Foundation for his research in the development of a microchip device capable of identifying cancer cells. At the time, Toner was identified as a member of the senior scientific staff at the Shriners Hospital for Children and the founder of the NIH BioMicroElectroMechanical Systems Resource Center at Massachusetts General Hospital (Boston).

Axis-Shield profits up this year ... Axis-Shield (Norton, Massachusetts) has reported half year profits of £7.5 million up from £1.6 million in 2008. The company has developed testing systems for a wide variety of conditions and diseases like diabetes, athritis and septicemia. Axis-Shield said it had performed well over the past year, despite the global recession. It said healthcare expenditure had remained relatively immune to the current economic downturn.

Diagnostic Hybrids gains FDA clearance for Thyretain Assay ... Diagnostic Hybrids (Athens, Ohio) reported the FDA clearance, for marketing under the 510(k) pre-notification process, of the Thyretain TSI Reporter BioAssay. Thyretain is an in vitro diagnostic use test that specifically detects auto-antibodies called thyroid stimulating immunoglobulins (TSI) in patient serum. Thyretain is the first FDA-cleared test that specifically detects TSI and is to be used as an aid in the differential diagnosis of Graves' disease, an autoimmune thyroid disorder. The Thyretain TSI Reporter BioAssay Kit is available for commercial use after a recently completed, 2-phase multi-site, clinical trial of the product in nearly 600 patients. Graves' disease is characterized by the presence of TSI in the bloodstream which results in over-stimulation of the thyroid gland and low thyroid stimulating hormone (TSH) levels, a condition known as hyperthyroidism. Eighty percent of Graves' disease cases occur in women, and can be difficult to diagnose because symptoms vary greatly and often mimic other illnesses. "Initial symptoms for thyroid disorders can often be nonspecific," said Frank Schwartz, MD. "By finding TSI's in patient serum, Thyretain is a rapid and reliable bioassay that provides a definitive assessment that could lead to earlier diagnosis of Graves' disease and better patient management." Schwartz is Professor of Endocrinology and J.O. Watson Chair for Diabetes Research and Director of the ARHI Diabetes Center at the Ohio University (Athens, Ohio) College of Osteopathic Medicine. Thyretain provides laboratories with the ability to test for TSI using standard laboratory equipment, and unlike other non-specific thyroid-related assays, does not require the use of radioactivity and eliminates ambiguity of test results that can be confounded by the presence of non-TSI auto-antibodies. The kit includes a genetically-engineered cell line that produces the reporter enzyme luciferase in response to specific TSI binding and the amount of luciferase produced is then rapidly detected using a luminometer. Graves' disease affects 1%-2% of the population, and mostly appears in women in their forties. Thyretain will enable physicians to detect TSI in the bloodstream and assist them in confirming the diagnosis of Graves' disease sooner than with standard thyroid test panels only.

Safeguard reduces stake in Clarient ... Safeguard Scientifics (Wayne, Pennsylvania) has reduced its stake in Clarient (Aliso Viejo, California) a lab-diagnostics company, to about 31% after selling 16 million shares. Safeguard sold its shares to institutional investors, and now holds 30.5 million shares of Clarient common stock, and warrants to purchase an additional 2.8 million shares. An overallotment option will let the underwriters buy up to 2.4 million more shares from Safeguard over the next 30 days. Clarient has been partnered with Safeguard since 1996.

Researchers find new cancer prognosis method ... Researchers led by Dr. Soheil Dadras at the Stanford University Medical Center (Stanford, California) reported that they have developed a novel methodology to extract microRNAs from cancer tissues. The related report by Ma et al, "Profiling and discovery of novel miRNAs from formalin-fixed paraffin-embedded melanoma and nodal specimens," appears in the September 2009 issue of the Journal of Molecular Diagnostics. Cancer tissues from patients are often stored by a method that involves formalin fixation and paraffin embedding to retain morphological definition for identification; however, this method frequently prevents further molecular analysis of the tissue because of mRNA degradation. Even so, these tissues contain high numbers of microRNAs (miRNAs), which are short enough (~22 nucleotides) to not be broken down during the fixation process.In this study, Dr. Dadras and colleagues optimized a new protocol for extracting miRNAs from formalin-fixed paraffin-embedded tissues. Using their new procedure, they identified 17 new and 53 known miRNAs from normal skin, melanoma, and sentinel lymph nodes. These miRNAs were well-preserved in a 10-year-old specimen. This new protocol, therefore, will allow for the identification of novel miRNAs that may differ in cancerous and healthy tissue, even from long-preserved tissue, leading to better predictions of disease prognosis and treatment response. Ma et al suggest that their "cloning strategy has the advantage of not only discovering novel and known miRNA sequence identity but also providing an estimate of relative expression level ... [This methodology may provide] a more robust strategy to obtain an accurate expression profile for novel and/or previously characterized small RNAs from clinically defined [formalin-fixed paraffin-embedded] tumor specimens, thereby facilitating the discovery of 'oncomirs' as biomarkers."

Electric nose 'sniffs' out kidney disease ... An "electronic nose" that can sniff out chronic renal failure could offer a noninvasive and fairly inexpensive way to detect kidney disease in the earliest and most treatable stages, according to Technion-Israel Institute of Technology (Haifa, Israel) researchers who developed the technology. In tests, the technology identified 27 volatile organic compounds in the exhaled breath of laboratory rats with no kidney function. The scientists then narrowed that down to the five most important compounds that signal the development of kidney disease. The findings were published recently in the journal ACS Nano. The next step in the research is to get the technology to distinguish between various types of kidney disease and identify their stages, the researchers said. The technology, developed to detect cancer from breath samples, is now being tested on breath samples from kidney disease patients.

– Compiled by Omar Ford, MDD;