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Sherlock starts clinical trial for rapid OTC diagnostics for STIs
Clinical Trials Arena via Yahoo Finance· 10 hours agoSherlock plans to use the data to support a marketing authorisation with the US Food and Drug...
Roche and Hitachi High-Tech extend their 46-year partnership, paving the way for further...
FOX 4 Kansas City· 5 days agoRoche announced today that Hitachi High-Tech and Roche have extended their partnership, committing...
Clinical lab industry sues to block FDA’s new oversight of lab-developed tests
FierceBiotech· 6 hours agoThe U.S. trade group representing laboratory companies and test manufacturers is suing to block the...
Surmodics agrees to $627M private equity buyout
MedTech Dive via Yahoo Finance· 12 hours agoDive Brief: Surmodics, a maker of medical device coatings and diagnostics components, has agreed to sell to a private equity firm for approximately $627...
Lab industry sues to stop FDA’s new LDT rule
MedTech Dive via Yahoo Finance· 1 day agoThe FDA moved forward with the controversial rule in April, tightening its oversight of the widely used tests in an effort to make them safer and more...
Will FDA's LDT Final Rule Bring "Balance to the (IVD) Force"? | JD Supra
JD Supra· 4 days ago...the calendar prevented publication in the Federal Register on Saturday May the 4th, but the Final Rule nonetheless puts an exclamation point on the Agency's decades-long goal to "correct the imbalance" between in vitro diagnostics (IVDs) marketed outside a laboratory and those IVDs manufactured...
Qiagen, Myriad Genetics to Develop Sequencing-Based Homologous Recombination Deficiency Kit
GenomeWeb News· 6 hours agoUnder the terms of the agreement, Qiagen will manage the development and distribution of HRD test kits outside the US. Qiagen has been granted the rights to collaborate with pharmaceutical partners ...
In Brief This Week: Illumina, Sophia Genetics, Thermo Fisher, Precision for Medicine, More
GenomeWeb News· 7 hours agoIllumina disclosed in its Form 10-Q filed earlier this month with the Securities and Exchange Commission that it is cooperating with the US Department of Justice on a False ...
Surmodics (NASDAQ:SRDX) Rating Reiterated by Lake Street Capital
ETF DAILY NEWS· 18 hours agoSurmodics (NASDAQ:SRDX – Get Free Report)‘s stock had its “hold” rating reaffirmed by analysts at Lake Street Capital in a note issued to investors on Wednesday, Benzinga ...
JD Supra: FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
JD Supra· 57 minutes agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will ...
