-
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
-
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
-
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
-
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
-
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
-
Labroots |
Stanford scientists identified a specific pattern of gene expression that occurs across different viral infections.
Dec 18, 2015
-
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
-
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
-
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
-
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
-
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
-
Nature News |
Dwindling algae harvests imperil a reagent essential for culturing microbes in the lab.
Dec 8, 2015
-
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
-
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
-
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
-
Diagnostics World | Thermo Fisher Scientific announced this week that it will be creating a next-generation sequencing test as a companion diagnostic in cases of non-small cell lung cancer, partnering with Novartis and Pfizer.
Nov 20, 2015
-
STAT |
After physician groups raised concerns about overdiagnosis and overtreatment of prostate cancer, fewer men are having PSA tests, with unknown results for public health.
Nov 20, 2015
-
Diagnostics World Boston Children’s Hospital has announced the results of the CLARITY Undiagnosed challenge, the second CLARITY crowdsourced competition sponsored by the Manton Center for Orphan Disease Research at Boston Children's and the Department of Biomedical Informatics (DBMI) at Harvard Medical School. CLARITY 2 exposed disparity in the ways variants are translated into medical findings, especially in particularly challenging cases.
Nov 17, 2015
-
Diagnostics World | The New England Journal of Medicine has published an opinion piece by Drs. Hardeep Singh and Mark Graber, calling for healthcare reforms to reduce the rate of diagnostic errors. According to a recent report by the Institute of Medicine, a typical American can expect to receive at least one misdiagnosis in the course of his or her lifetime.
Nov 11, 2015