PCR: Page 2

Co-Diagnostics submits 510(k) applications for platform, OTC COVID-19 test
By LabPulse.com staff writers
Molecular diagnostics firm Co-Diagnostics submitted its first U.S. Food and Drug Administration application for 510(k) clearance for its Co-Dx PCR Pro instrument, along with the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use.
June 17, 2024
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Qiagen gets FDA clearance for respiratory syndromic testing panel
By LabPulse.com staff writers
Qiagen announced that it has received U.S. Food and Drug Administration (FDA) clearance for its QIAstat-Dx respiratory syndromic testing panel for clinical use.
May 14, 2024
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Qiagen partners with FBI on forensics assay
By LabPulse.com staff writers
Qiagen has announced a collaboration with the FBI to develop a new assay to improve DNA quantification for use in forensics and human identification.
May 8, 2024
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AMDI receives $5.2M in RADx Tech funding for PCR viral testing system
By LabPulse.com staff writers
Autonomous Medical Devices Incorporated (AMDI) has received a U.S. National Institutes of Health (NIH) RADx Tech award of up to $5.2 million to finalize its rapid point-of-care viral testing system.
March 4, 2024
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Thermo Fisher launches new instrument, kit for respiratory testing
By LabPulse.com staff writers
Thermo Fisher Scientific has launched a nucleic acid purification instrument and kit for automated viral and bacterial respiratory testing.
December 11, 2023
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Researchers develop technique for onsite detection of SARS-CoV-2
By LabPulse.com staff writers
Researchers have developed a portable laboratory device for rapid onsite detection of SARS-CoV-2 RNA which holds promise for scenarios in which there is no or limited access to testing laboratories.
October 10, 2023
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NIH researchers develop PCR assay for easier diagnosis of river blindness
By LabPulse.com staff writers
U.S. National Institutes of Health (NIH) researchers have developed a new PCR assay to detect Onchocerca volvulus, the parasite that causes onchocerciasis, or river blindness, and are working to adapt it for easier field diagnosis of the disease.
October 9, 2023
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Nonprofit health system adopts Immunexpress test for detecting sepsis
By Nick Paul Taylor
FirstHealth of the Carolinas, a nonprofit health system licensed for four hospitals in North Carolina, will use Immunexpress’ SeptiCyte Rapid test to help differentiate sepsis-positive cases from patients with infection-negative systemic inflammation.
August 23, 2023
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ChromaCode starts early-access launch of lung cancer variant test
By Nick Paul Taylor
The test is designed to address diagnostic problems that prevent patients from undergoing timely cancer biomarker testing and receiving targeted therapies.
August 15, 2023
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Studies show Pathnostics UTI test required fewer resources, reduced costs compared to standard testing
By LabPulse.com staff writers
In the study, the average one-year costs related to UTIs were $501.85 lower for patients receiving treatment based on the Guidance test than for those receiving treatment based on the traditional culture test.
June 20, 2023
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Roche receives WHO prequalification for HPV screening tool
By LabPulse.com staff writers
Prequalification helps expand access to the screening tool in countries that rely on the WHO's list of prequalified suppliers in making purchasing and implementation decisions.
June 13, 2023
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Eurobio Scientific obtains IVDR CE markings for PCR tests
By LabPulse.com staff writers
The CE markings enable the firm to market three of its PCR tests as class C in vitro diagnostic medical devices for the detection of infectious diseases.
May 24, 2023
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