Connection Between Epigenome, Selective Mutability, Evolution, and Human Disease
Li, Harris et al., PLoS Genetics
Researchers at the Baylor College of Medicine and elsewhere propose a "connection between the epigenome, selective mutability, evolution, and human disease" based on the findings of their study on associations of structural mutability with germline DNA methylation and with non-allelic homologous recombination mediated by low-copy repeats. "Combined evidence from four human sperm methylome maps, human genome evolution, structural polymorphisms in the human population, and previous genomic and disease studies consistently points to a strong association of germline hypomethylation and genomic instability," the Baylor-led team writes.
OraSure on Track to Catch Swelling Wave of Workplace Drug Testing
OraSure Technologies has won 510(k) clearance for a quartet of homogeneous, fully automated oral fluid drugs-of-abuse assays and plans to begin selling them later this year.
The tests, developed with Roche to be used exclusively on OraSure's Intercept oral fluid drug-testing system, look for the presence of phencyclidine, or PCP; cocaine; opiates; and methamphetamine.
Most common drugs of abuse assays rely on urine samples and are processed on microplate technology. By comparison, OraSure's tests — the companies say more are to come — can now be processed on saliva using automated analyzers. OraSure claims this medium could make for more efficient testing.
The clearances could also enable OraSure to benefit from a growth in workplace drug use, which has led to a rise in drug testing.
As I wrote last month, a drug-testing study performed annually by Quest has shown that workplace prescription drug use has increased "dramatically" in recent months.
The number of workers taking prescription narcotic analgesics — opiates, which is one of the four OraSure tests cleared by FDA — while on the clock increased 18 percent between 2008 and 2009, according to more than 5.5 million urine samples tested by the reference lab. The study didn't say whether the drugs are being taken illicitly, via a prescription, or through doctor-shopping.
Indeed, if there is a bright spot to Quest's study results it is that the practice of workplace drug testing is on track to become a significant volume driver for labs that perform or offer such services, including OraSure.
OraSure's assays, which use Roche's KIMS, or kinetic interaction of micro-particles in solution technology, were jointly developed under an ongoing agreement between the two companies.
The tests are designed to run on various clinical-chemistry automated analyzers, which "are intended to allow oral fluid samples to be processed with the same efficiency as current fully automated urine-based drug tests."
The combination of Roche's chops in lab-instrumentation and reagent-chemistry development and OraSure's experience in oral-fluid technology and sample-collection devices "has enabled us to bring to market a … system that will have an immediate and positive impact on laboratory efficiency for drugs of abuse testing," OraSure CEO Douglas Michels said in a statement.
Several additional assays are also in development and are currently in varying stages of submission with the FDA. The companies did not elaborate.
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