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.
IRIS Expects to Debut Post-Prostatectomy Cancer-Risk IVD in Late 2010
IRIS International's molecular diagnostics division has submitted its prostate cancer-recurrence prognostic for 510(k) review, the company said today.
The test, called ProsVue, monitors residual PSA levels to help identify patients who have undergone radical prostatectomy and who are at low risk of cancer recurrence. The "low-risk" distinction is aimed at reducing unnecessary treatment.
There are around 85,000 new radical prostatectomies performed in the US each year, and success rates for the procedure can range from 30 percent to 98 percent.
IRIS, based in Chatsworth, Calif., has said it expects to launch the assay late this year or early next year and begin generating "significant" revenue from it in 2011.
ProsVue can expect some competition. Myriad Genetics last month launched its Prolaris assay, a 46-gene prognostic the company claims is the first test to gauge post-prostatectomy cancer recurrence.
Another test is the Prostate Cancer Microarray assay, developed by embattled Combimatrix Molecular Diagnostics, which aims to stratify cancer patients according to risk of recurrence and metastasis post-prostatectomy.
And German test maker Epigenomics is developing an array-based assay designed to assess the risk of prostate cancer recurrence by profiling 21 distinct detection probes in the PITX2 gene that affect DNA methylation.
IRIS said the ProsVue is the first based on its NADiA technology, which stands for Nucleic Acid Detection Immunoassay. The others include a test designed to monitor HIV viral load during anti-retroviral therapy and a Her-2/neu assay.
The HIV test, which is "in development," is designed to measure the p24 protein, which is believed to be present in greater numbers relative to HIV RNA, which is what traditional viral-load tests scrutinize. The Her-2/neu test, which IRIS says is in the "feasibility" stage, will be designed to identify and quantify levels of Her-2/neu in circulating breast cancer cells.
IRIS Molecular Diagnostics was formed in 2006 after its parent company acquired Leucadia Technologies in order to tap into the "higher value" MDx market, an IRIS spokesperson told me today.
The firm is still building its molecular diagnostic web page. The parent company's 2009 year-end SEC filing has some basic information about its MDx play.