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FDA Authorizes First COVID-19 At-Home Test
americanpharmaceuticalreview
April 24, 2020
The U.S. Food and Drug Administration (FDA) has authorized the first diagnostic test with a home collection option for COVID-19.
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Thermo Fisher Scientific to enhance capacity for COVID-19 testing in India
expresspharma
April 06, 2020
Thermo Fisher Scientific announced that it is accelerating its efforts with diagnostic testing and vaccine development technologies to effectively manage COVID-19 outbreak in the country.
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Mologic, Partners Begin Validation Process for COVID-19 Point-of-Need Diagnostic Test
americanpharmaceuticalreview
March 27, 2020
Mologic has initiated early validation of COVID-19 point-of-need diagnostic tests with the Liverpool School of Tropical Medicine and St Georges’ University London.
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Roche launches first in vitro lung cancer diagnostic test
pharmatimes
June 11, 2019
Roche Diagnostics has launched its first in vitro diagnostic test to target ROS1 positive lung cancers, VENTANA ROS1 (SP384) Antibody.
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FDA permits marketing of first diagnostic test for detection of prosthetic joint infections
biospectrumasia
May 29, 2019
The Synovasure Lateral Flow Test Kit detects proteins called human alpha defensins in the synovial fluid of patients with a total joint replacement in approximately 10 minutes.
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A*Star, NEA & NCID develop diagnostic test for mosquito-borne diseases
biospectrumasia
April 25, 2019
A single test that can detect and differentiate multiple mosquito-borne viruses and their types
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Hematogenix launches FDA approved companion diagnostic test for Triple-Negative Breast Cancer
biospectrumasia
March 15, 2019
The companion diagnostic test that was approved by the FDA for selecting TNBC patients for TECENTRIQ is the VENTANA PD-L1 (SP142) assay.
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FDA: Thermography No Substitute for Mammograms
drugs
February 26, 2019
Despite claims to the contrary, thermography should not be used in place of mammography for breast cancer screening, detection, or diagnosis, according to the U.S. Food and Drug Administration.