Keeping you up to date on recent headlines in diagnostics.

Researchers find new way to determine condition of tooth enamel using laser ... A group of researchers in Australia and Taiwan have developed a new way to analyze the health of human teeth using lasers. As described in the latest issue of Optics Express, the Optical Society's (OSA; Washington) open-access journal, by measuring how the surface of a tooth responds to laser-generated ultrasound, they can evaluate the mineral content of tooth enamel — the semi-translucent outer layer of a tooth that protects the underlying dentin. This is the first time anyone has been able to non-destructively measure the elasticity of human teeth, creating a method that can be used to assess oral health and predict emerging dental problems, such as tooth decay and cavities. "The ultimate goal is to come up with a quick, efficient, cost-effective, and non-destructive way to evaluate the mineralization of human dental enamel," says David Hsiao-Chuan Wang, a graduate student at the University of Sydney in Australia and first author on the paper in Optics Express. Wang and his advisor Simon Fleming, a physics professor at the University of Sydney's Institute of Photonics and Optical Science, collaborated on the study with dental researchers at the University of Sydney and ultrasonic evaluation researchers at National Cheng Kung University in Tainan City, Taiwan.

McKesson broadens InterQual Clinical Guidelines for molecular diagnostics with new tests ... McKesson (San Francisco) reported that it has updated its InterQual Molecular Diagnostics Criteria to cover more than 380 tests, including a new category of pharmacogenomic tests that determine if an individual will be responsive to a drug based on genetic makeup. As the first vendor to provide a comprehensive set of evidence-based criteria to support decision-making for molecular diagnostic tests, McKesson is now extending the power of this offering to help healthcare payors and providers to ensure patients receive the most appropriate medical care and better manage medical spend. The added content in InterQual Molecular Diagnostics Criteria nearly doubles the number of tests included and addresses about 85%-90% of the costs in this growing area. Criteria for more than 70 pharmacogenomic tests are now available, including BCR-ABL1 (Philly Chromosome) and C-Kit for response to tyrosine kinase inhibitors used to treat certain types of leukemia, and KRAS for response to tyrosine kinase inhibitors for non-small cell lung cancer and advanced pancreatic cancer. Pharmacogenomic tests, which can predict individual patient response to many specialty pharmaceuticals, help patients get needed, effective care faster. Although they may cost anywhere from a few hundred dollars to over $1,000, these tests have the potential to save as much as $100,000 per year in unnecessary pharmaceutical spending.

Continucare acquires Professional Sleep Diagnostics ... Continucare (Miami) said it has purchased Professional Sleep Diagnostics (Concord, North Carolina), a company that operates 13 sleep diagnostic centers, for an undisclosed amount. Continucare is a physician outsourcing company. Professional Sleep Diagnostics has facilities located in North and South Carolina, Virginia, West Virginia, Colorado, and Ohio. Its centers conduct sleep studies to determine whether a person has a sleep disorder, and if so, what type of problem the person has. The best known sleep disorder is obstructive sleep apnea. Continucare says more than 18 million U.S. adults have sleep apnea.

SRL to start carrying out swine flu tests in labs ... Super Religare Laboratories, India's largest diagnostics network, has reported its preparedness to carry out all Influenza- A viral tests including H1N1 (Swine Flu) at its facilities which include 4 world class Reference Labs and 50 networked labs including several leading hospital based labs in the country. In line with its existing corporate philosophy of offering the best test facilities at the truly affordable value, SRL has decided to offer the test at Rs 4,000 which is much lower than the perceived price indicators for the test. All the SRL Labs meet the required Bio-Safety, Technology and Handling standards and are accredited by NABL, Govt of India. Looking at the increasing number of Swine Flu cases, government authorities have been inspecting the SRL labs and the facilities being offered by them to check their readiness in conducting the H1N1 tests. "Our facilities are stocked with adequate levels of reagents and probes required to carry out mass screening and we are absolutely ready to offer our services for swine flu testing to the Government of India and the fellow citizens at an affordable price point. Today we are the first private sector diagnostic chain to be ready and make the test available with this level of preparedness," said Dr Sanjeev Chaudhry, CEO, Super Religare Laboratories.

Angiologix develops cardiovascular illness detection test ... Angiologix (Mountain View, California) says it has developed a system that can detect cardiovascular disease earlier than existing tests. The system uses a cuff placed on the patient's arm, a hardware box and software programmed to detect the earliest sign of cardiovascular disease. It does this by finding damage to endothelial cells that line blood vessels. When these become diseased or dysfunctional, the vessels stop working properly and develop plaque, which can cause chest pain, heart attacks and stroke. Angiologix is now raising money to get through an FDA approval. It's seeking to raise $1.5 million in a Series B round. Gen3 Capital invested $1 million in 2008 and has committed $500,000 to this round.

Hologic supports fFN testing for preterm pregnancy risk ... Hologic (Bedford, Massachusetts) a developer of diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, reported the publication of the first of its kind study evaluating the impact of fetal fibronectin (fFN) testing among both symptomatic and asymptomatic pregnant women at risk for preterm birth. The study, "Does fetal fibronectin testing change patient management in women at risk of preterm labor?" by researchers at King's College (London, England) appears in the on-line version of the European Journal of Obstetrics & Gynecology and Reproductive Biology. The study conducted at the Maternal and Fetal Research Unit at St. Thomas' Hospital in London included nearly 100 clinically symptomatic and asymptomatic patients between 23 and 34 weeks gestation. After using the fFN test in both populations, clinicians were asked to determine if the results from the test changed the medical management of their patients. Clinician responses indicated that fFN testing had the potential to change management in nearly 90% of cases. The study concluded that fFN testing has the potential to improve risk assessment and impact treatment decisions including the administering of steroids, increased surveillance, or cerclage intervention in the asymptomatic high-risk population involved in the study. Hologic's fetal fibronectin test is an FDA-approved, non-invasive test that assesses the risk of preterm birth in women from 22 to 35 weeks gestation with known risk factors or with signs and symptoms of preterm labor. The fFN test measures the presence of fetal fibronectin, the glue-like substance that holds the baby in the womb. A negative result means fetal fibronectin is minimally present and there is a less than one percent chance of delivering in the next two weeks. A positive result is a strong independent predictor of preterm birth before 32 weeks.

— Compiled by Omar Ford, MDD