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GEN |
Cepheid will use newly adapted Xpert tests for common hospital associated infections as codiagnostics to support MedImmune's clinical trials of a new anti-infective biologic drug.
Jan 15, 2016
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Diagnostics World | Illumina, the dominant manufacturer of DNA sequencing technology, has
formed a spinoff company called GRAIL to experiment with a pan-cancer
blood test, an undertaking for which hundreds of thousands of patients
may be enrolled in clinical studies.
Jan 11, 2016
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San Francisco Business Times |
OrbiMed Advisors led the Series D financing for this San Francisco company, which for 18 months has had a product on the market to detect cancer through a simple blood draw.
Jan 7, 2016
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Diagnostics World | IQuity Labs, a diagnostics company spun out from research at Vanderbilt University Medical Center, today announced that it has raised $2 million in seed funding to support the rollout of its first test in the second quarter of this year.
Jan 7, 2016
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FierceMedicalDevices |
The FDA has cleared iHear Medical's hearing test for home use, as the agency looks to crack down on unreliable online assessments.
Jan 6, 2016
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Diagnostics World Brief | Scientists at the Fraunhofer Institute for Cell Therapy and Immunology have announced the creation of a specific antibody test for dengue fever, capable of ruling out related infections like West Nile virus.
Jan 5, 2016
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Triad Business Journal |
The $225,000 penalty follows an investigation by the New York attorney general's office into improperly ordered direct-to-consumer medical tests.
Jan 4, 2016
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Wall Street Journal | The blood-testing company founded by Elizabeth Holmes in 2003 has continually reinvented its approach and priorities as it fought to bring its low-cost, low-volume tests to market, but it has been dogged throughout by troubling accusations about its performance.
Dec 28, 2015
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FierceMedicalDevices |
Neural Analytics is developing portable transcranial Doppler ultrasound devices that it expects could be used by first responders and emergency room physicians to accurately assess mild to severe traumatic brain injury, including concussions.
Dec 22, 2015
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Labroots |
Stanford scientists identified a specific pattern of gene expression that occurs across different viral infections.
Dec 18, 2015
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The New York Times |
A screening test may reduce deaths from the hard-to-detect disease, but it needs more study to determine whether it holds up statistically.
Dec 18, 2015
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Diagnostics World Brief | Novogene and Illumina today announced an agreement to jointly develop advanced clinical applications in the fields of reproductive health and oncology based on next-generation sequencing (NGS) technology. The two companies will work together to develop a user-friendly diagnostic system for clinical prenatal DNA and oncology testing in the Chinese market.
Dec 14, 2015
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Diagnostics World News Brief | San Diego-based Nanomedical Diagnostics has appointed a scientific advisory board to guide early development of a portable diagnostic platform, beginning with a rapid test for Lyme disease.
Dec 11, 2015
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Diagnostics World | The deadline has been extended for entry into the 2nd Annual Swimming with the Sharks competition to be held at CHI’s Molecular Medicine Triconference in San Francisco in March. Companies now have until December 31 to submit their entries.
Dec 10, 2015
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Diagnostics World | In a paper published last week in Genetics in Medicine, GeneDx reported the results of whole exome sequence analysis for 3,040 cases the company sequenced over three years. Based on their experiences, the researchers recommend that whole exome sequencing increasingly be considered as a first-line diagnostic test.
Dec 9, 2015
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Nature News |
Dwindling algae harvests imperil a reagent essential for culturing microbes in the lab.
Dec 8, 2015
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Washington Post |
Internal emails show that a military official started an inquiry with the FDA about Theranos's regulatory compliance years before the company's current travails.
Dec 2, 2015
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Diagnostics World | Quanterix, the Lexington, Mass.-based creator of a high-throughput protein analysis instrument, is overhauling its hardware and software as it prepares for a more commercial stage in its development.
Nov 25, 2015
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New York Times |
As the FDA continues to seek more authority to regulate laboratory developed tests, the agency has released information from 20 case studies of inaccurate or unreliable tests.
Nov 24, 2015