molecular diagnostics
New Diagnostic Could Predict Risk of Recurring Prostate Cancer
A new molecular diagnostic may be able to accurately predict the risk of recurrent prostate cancer. In a study published in the Proceedings of the National Academy of Sciences, researchers at Massachusetts General Hospital and bioTheranostics (San Diego, CA) announced positive results for the new diagnostic based on a study of 270 prostate cancer tumor samples. The Prostate Cancer Index is a specialized 32-gene diagnostic that can help physicians predict the advance and recurrence of...
BioFire Lands $45-Million Cash Infusion
Biofire Diagnostics (Salt Lake City, UT; covered in IVD Technology last year when it rebranded from the former "Idaho Technology") transformed a $25-million financing round into a cash infusion of $45 million. The company secured the additional funding in an effort to spur commercialization of its molecular diagnostic tools. A financial firm named Athyrium Opportunities Fund provided the additional $25 million (with up to an additional $20 million). One principal at the firm...
Roche Cuts 170 Jobs in Germany and Conneticut
 Roche (Basel, Switzerland) will eliminate 170 jobs in its applied sciences division. Remaining employees and other resources will be shifted to the company’s diagnostics division. Over the past few years, Roche’s research technology division has been on the decline. In the last quarter, sales at the company’s applied sciences division dropped 10 percent. This is due in part to lower research budgets around the world. As a result, the company will cut 110 jobs at...
Thermo Fisher Acquires Life Technologies for $13.6 Billion
  Life Technologies (Carlsbad, CA) has agreed to an acquisition by Thermo Fisher Scientific (Waltham, MA). With Life Technologies, the healthcare products giant will gain access to the DNA sequencing market. In particular, Life Technologies’ marquee Ion Torrent sequencer is of interest. Thermo Fisher stated that many of Life Technologies’ products work well with its existing point-of-care, research and molecular diagnostics. Thermo states that the acquisition could be...
FDA Clears GI Assay by Luminex
Luminex (Austin, Texas) received clearance from FDA for its MagPix instrument, featuring the xTag Gastrointestinal Pathogen Panel (xTag GPP). According to a press release by the company, this is the first clinical assay designed for the MagPix platform to receive FDA clearance. The xTag GPP assay can detect 11 different parasitic, bacterial, and viral infections that can lead to gastroenteritis. The system has the ability to perform quantitative and qualitative analysis of nucleic acids...
LipoScience, HTG Molecular Diagnostics, BioNano Genomics Named MDEA Finalists
What do IVD products from LipoScience, HTG Molecular Diagnostics, and BioNano Genomics have in common? Remarkable design, according to those judging the Medical Design Excellence Awards (MDEAs) this year. Products from these three companies are the official finalists in the IVD category of the competition for 2013. MDEA judge Mark Vreeke, PhD The MDEA is the medtech industry’s premier competition for medical device and diagnostic design and innovation. This year marks the...
Quidel Corp. Earns CE Mark for HSV 1+2/VZV Molecular Assay
Quidel, a healthcare diagnostics manufacturer based in San Diego, California, announced that it received CE Mark clearance from the European Union for its new Quidel Molecular Direct test. According to a press release by the company, the Quidel Molecular Direct HSV 1+2/VZV assay can detect HSV 1, HSV 2 and VZV. HSV 1 is the virus that causes many cold sores and some cases of genital herpes. HSV 2 is responsible for some cold sores and the majority of genital herpes cases. VZV causes shingles in...
Asuragen Molecular Dx Test Shown to Be Effective at Detecting Fragile X Syndrome
Asuragen, a molecular diagnostics manufacturer based in Austin, Texas, announced positive research results for one of its molecular diagnostic tests. According to the company, the Xpansion Interpreter molecular test demonstrates efficacy in determining the likelihood that a mother will give birth to a child with Fragile X syndrome. Fragile X syndrome is a genetic syndrome that is the most common single-gene cause of autism and mental retardation. Fragile X syndrome can lead to intellectual...
PCR Technology Agreement with Focus Diagnostics Marks ‘Renewed Focus’ on Life Sciences for Evogen
Focus Diagnostics of Cypress, CA, has licensed the worldwide rights to incorporate Evogen’s HyBeacons PCR probe technology for use in molecular products and services, the companies announced. The technology has multiplex capability for identifying several targets in a single reaction, according to Evogen. Focus, a subsidiary of Quest Diagnostics, specializes in testing for infectious diseases and manufactures the Simplex line of test products for diagnosing flu, C. difficile, Epstein-Barr...
Biosearch Technologies, UMDNJ Stellaris Probe Alliance in Research and Clinical Applications
Biosearch Technologies Inc., a supplier of oligonucleotide components to the  molecular diagnostics industry, has announced that the company has acquired exclusive worldwide rights to continuing Stellaris RNA FISH--based inventions from the University of Medicine and Dentistry of New Jersey (UMDNJ). In addition to offering single-molecule detection of mRNA, lncRNA, and viral RNAs, Stellaris-based methods have been extended to directly and quantitatively detect chromosomal diseases caused...