Molecular Diagnostics
EKF Molecular To Launch Cancer Gene Detection Technologies at ASCO 2013
EKF Diagnostics (Cardiff, UK) has announced it will launch its Molecular Diagnostics division's PointMan DNA Enrichment kits at the end of this month at the ASCO 2013 annual meeting in Chicago. The global launch will comprise three kits for enriching mutations in BRAF, KRAS, and EGFR T790M genes associated with skin melanoma and colorectal and lung cancers. PointMan kits offer highly specific and ultra-sensitive enrichment of mutant genes in a background of wild-type (normal) genes that is...
FDA Approves Lung Cancer Diagnostic by Roche
Roche (Indianapolis, IN) received FDA approval for a lung cancer companion diagnostic and its associated therapy, Tarceva. The Cobas EGFR Mutation Test looks for the presence of a specific mutation that is implicated in the development of non-small-cell lung cancer. The EGFR mutation test is used to check for the presence of epidermal growth factor receptors in a patient’s genome. Depending on test results, physicians will be able to prescribe Tarceva, a tablet cancer treatment that...
Cizzle, Fujirebio Join Forces to Develop Lung Cancer Dx
A new collaboration between a Japanese company and a startup in the United Kingdom could lead to the development of a new early-stage lung cancer diagnostic. Cizzle Biotechnology has licensed its technology and patents for a lung cancer diagnostic to Fujirebio Diagnostics. Under the terms of the loan, both companies will work together to develop the new test. U.K.-based Cizzle Biotechnology was spun out from York University. Fujirebio Diagnostics (Malvern, PA) is a division of Japan-based...
MSU Researchers Develop New Malaria Diagnostic
A new blood diagnostic by researchers at Michigan State University could help spot dangerous forms of malaria in children. Researchers detailed their findings in the Journal of Infectious Diseases. The research project was done as a joint collaboration with the University of Malawi. The mosquito-transmitted malaria parasite produces a unique protein known as HRP2. The new diagnostic developed by researchers looks for levels of HRP2 in a patient’s blood. Results from the study show that...
Sequenom's Revenue and Costs Up in First Quarter
Sequenom (San Diego, CA) released a positive first quarter earnings report, buoyed by solid sales of its MaterniT21 Plus test. With a 158% increase in first quarter revenue, the company has established itself as a solid player in the prenatal testing business. While revenues at the company were positive, these increases did come at a significant price. Costs at the company doubled from the first quarter of 2012. While revenue was $38.5 million, the company experienced a net loss of $29.4...
Spanish STAT-Diagnostica Scores $22 Million in Series-B Round
Barcelona-based STAT-Diagnostica announced the end of a Series B financing round that brought in $22.1 million (U.S., or 17 million Euros). The Spanish company says it will use the windfall to complete development of its near-patient-testing diagnostic system, and clinical validation of its first products. Led by Kurma Life Sciences Partners, a new investor, the round also drew participation from new investors Idinvest, Boehringer Ingeheim Venture Fund, and Caixa Capital Risc. STAT-Diagnostica...
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...
InstantLabs' Listeria Test Kit Earns AOAC Certification
Nonclinical diagnostics news: InstantLabs Medical Diagnostics Corp., the company that developed the portable Hunter Accelerated Real-Time PCR system, announced that its Listeria Species Food Safety Kit has received the Association of Analytical Communities' (AOAC's) Performance Tested Methods certification for environmental and food matrices. Bacteria of the Listeria genus are an increasingly prevalent and dangerous concern in the food-safety industry. The Listeria food-safety kit has been...
Natera Raises $54.6M for Panorama Test Marketing Push and Expansion
Natera, a genetic-testing company that is very active in the noninvasive prenatal testing space, announced today that it has completed a $54.6-million financing round to expand and globally market its Panorama test. The test detects such chromosomal abnormalities as Trisomy 21, Trisomy 18, Trisomy 13, and Monosomy X, and it demonstrates a specificity of 100% with no false positives for all the syndromes tested, Natera says. It uses fetal cell-free DNA found in maternal blood and can be deployed...