Molecular Diagnostics
Signal Genetics Acquires ChipDX, a Prognostic-Cancer-Test Company
Signal Genetics, a privately held predictive-genetic-testing company focused on oncology and headquartered in New York City, announced that it will acquire all assets of ChipDX LLC (New York City), a prognostic-cancer-test company, including patents for prognostic tests in lung, breast, and colon cancers. The announcement appeared on MarketWatch.com. As part of the transaction, Signal will acquire the BreastGeneDX, ColonGeneDX, and LungGeneDX tests, all of which are in...
Roche vs. Illumina: The Drama Intensifies
  Update: The New York Times' Dealbook blog posted this in-depth look at the loophole in Illumina's organizational documents that is making it possible for Roche to gain the advantage.   As we blogged about last week, Roche intends to buy Illumina Inc., an international company headquartered in San Diego that develops and manufactures array-based systems for DNA, RNA, and protein analysis. However, Illumina's Board of Directors appears to be uninterested in Roche’s offer and has...
A Roche Technology Helps to I.D. Genetic Mutations Related to Hearing Loss
Roche reports that a German research team led by Ingo Kurth from the Institute of Human Genetics at the University Hospital used various methods, including Roche’s NimbleGen Custom Sequence Capture 385K array, to identify the gene mutated in the disease locus of the X-chromosome of a Spanish family with hereditary hearing loss. Targeted enrichment was performed by the German Service Provider ATLAS Biolabs GmbH. In particular, the DNA of two affected males was subjected to target...
LipoScience Submits 510(k) for Nuclear Magnetic Resonance-Based Diagnostic
LipoScience Inc., a North Carolina-based diagnostic company that utilizes nuclear magnetic resonance (NMR) technology in clinical tests, announced that it has submitted the Vantera Clinical Analyzer and the NMR LipoProfile test to FDA for 510(k) clearance. If cleared, Vantera would become the first clinical diagnostic platform based on NMR commercially available for IVD use, the company says. Vantera combines proprietary signal processing algorithms and NMR...
Noninvasive prenatal testing for Down syndrome discussed at AMP annual meeting
GenomeWeb's The Daily Scan reports the following today: At the annual meeting of the Association for Molecular Pathology this week, the Chinese University of Hong Kong's Dennis Lo spoke about bringing non-invasive prenatal diagnostic testing to the clinic using next-generation sequencing. Some women choose to undergo invasive prenatal diagnostic testing for Down syndrome, Lo said. Testing for Down syndrome using the mother's blood is challenging, because trace amounts of fetal DNA are...
MDxHealth Reports Positive Results for Prostate Cancer Diagnostic Test
MDxHealth SA announced data showing that a prototype of its Prostate ConfirmMDx test can help urologists distinguish patients who have a true negative biopsy from those who may have occult cancer undetected by prostate biopsy and histopathological review. If this early data is validated in a larger study, the results suggest that 30% of men suspicious for cancer after an initial negative biopsy could be spared a repeat biopsy. Prostate ConfirmMDx detects epigenetic changes in specific prostate...
Meridian Bioscience Plans To Launch Several New Illumigene Tests
Included in Meridian Bioscience's press release summarizing the company's fourth-quarter and full-year earnings are comments regarding soon-to-be-launched Illumigene tests. Illumigene is a molecular-amplification platform. Meridian Bioscience says in the release that it is awaiting FDA clearance to market two new tests: Illumigene GBS for streptococcus Group B, and ImmunoCardSTAT! GDH, a rapid screening test for C. difficile. "In addition," the release reads, "we expect two to...
Rosetta Genomics Announces Exclusive License with Avatao Biotech
As reported in PR Newswire, Rosetta Genomics (Rehovot, Israel), a developer and provider of microRNA-based molecular diagnostic tests, announced that it has executed a license agreement with Avatao Biotech, a biotechnology company developing and distributing diagnostic products in China. The license grants Avatao the exclusive rights to market miRview mets and miRview mets(2), Rosetta's microRNA-based diagnostic tests, in China. Avatao will also have the exclusive rights to market one...
Study Gauges Emotional Toll of Direct-to-Consumer Genetic Testing
Among the latest healthcare trends seeking to advance individualized medicine are private companies marketing genetic testing directly to patients. The mail-in kits, with price tags as high as $2,500, use a saliva specimen to identify small variations in the human genome (called single nucleotide polymorphisms or SNPs) associated with heightened risk for diseases such as diabetes and prostate cancer. FDA has raised concerns about whether the tests are clinically beneficial and has advocated...
HTG Molecular Diagnostics Launches New Version of MicroRNA Screening Product
HTG Molecular Diagnostics announced the availability of the qDiscovery miRNA Whole Transcriptome Array (WTA) Version 16, a complete solution for microRNA (miRNA) analysis on any sample type or size. This array is an update to the previous Version 11 which measures all known human, rat and mouse miRNA in a single sample well with a quality control tested list of available miRNA genes. It also includes 35 of the top endogenous housekeeping mRNA genes for data...