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FDA Approves Qiagen's PIK3CA Test as Companion Test for Novartis Breast Cancer Drug
2019-05-29
The US Food and Drug Administration has approved Qiagen's Therascreen PIK3CA RGQ PCR Kit as a companion diagnostic for identifying which advanced breast cancer patients have PIK3CA mutations and are likely to respond to Novartis' alpelisib (Piqray).
Roche Obtains FDA Clearance for Sexually Transmitted Disease Test
2019-05-29
Roche said recently that it has received US Food and Drug Administration 510(k) clearance for its Cobas TV/MG test for the detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in symptomatic and asymptomatic patients.
PreludeDx Receives New York State Approval for DCIS Test
2019-05-27
PreludeDx said recently that the State of New York Clinical Laboratory Evaluation Program (CLEP) has approved its DCISionRT test
Thermo Fisher Scientific to Invest $50 Million in Bioproduction Expansion
2019-05-27
On May 20, 2019, Thermo Fisher Scientific announced that it is investing more than $50 million into its global bioproduction capabilities.
Velano Draws $10M Growth Funding for Needle-Free Blood Collection Technology
2019-05-27
Velano Vascular has secured $10 million as the initial tranche of a growth financing to fuel commercialization and the launch of new vascular access solutions.
New Vein Access Device Could Benefit Nurses and DIVAs Alike
2019-05-27
Schaffhausen, Switzerland-based Physeon is trying to bring its Veinplicity device to the U.S. market.
Medical Design Excellence Awards 2019 Finalists: Testing and Diagnostic Products and Systems
2019-05-27
Atellica Solution is a multi analyzer system for in vitro diagnostic testing of clinical specimens.
How POC Diagnostics Are Becoming the Norm
2019-05-27
Point-of-care (POC) testing is a rapidly growing market.
FDA Cites Defibrillator Battery Maker for Quality Violations
2019-05-27
A November 2018 FDA inspection has resulted in a warning letter for Zeller Power Products.
The Robots Are Coming, Are You Ready?
2019-05-27
Robotics in medtech are quickly becoming common place as the number of companies in the market continue to grow.
Grail Sets Fast Pace in Liquid Biopsy with New Milestones
2019-05-27
Grail has hit a major milestone as the liquid biopsy company is reporting...
Curetis to Receive �6.5M in Financing
2019-05-24
German molecular diagnostics firm Curetis said recently that it will receive �6.5 million ($7.3 million) in gross proceeds under two financing facilities.
NeoGenomics Prices $149M Public Offering of Common Stock
2019-05-24
NeoGenomics said after the close of the market recently that it has priced its previously announced underwritten public offering of 7 million shares of its common stock at a public offering price of $21.25 per share.
FDA Grants IDE Approval for Almac Diagnostic Services' CDx for Use in Cancer Drug Study
2019-05-24
Turning Point Therapeutics and Almac Diagnostic Services recently announced approval by the US Food and Drug Administration of an investigational device exemption for use of an Almac diagnostic assay to determine......
PrediLife Partners With Institut Curie on Breast Cancer Risk Test
2019-05-24
PrediLife said recently that it has signed on the Institut Curie to perform the genetic analysis portion of its MammoRisk breast cancer risk assay.
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