Breast Cancer Index Test Data Reinforces Efficacy
Hologic and Biotheranostics unveiled new data showing that the Breast Cancer Index (BCI) test improves treatment decision-making.
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BD HPV Assay Gets FDA Approval for Use with Two Pap Tests
BD, a global medical tech company, announced U.S. FDA market approval for the BD Onclarity HPV Assay to be used with the ThinPrep Pap Test.
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Hologic Launches Multiplex COVID-19/Flu Test in North America and Europe
The Aptima SARS-CoV-2/Flu Assay from Hologic tests simultaneously for SARS-CoV-2, influenza A, and influenza B on the Panther molecular diagnostics system.
Hologic to Acquire Molecular Diagnostics Company Biotheranostics
Biotheranostics is a privately held, commercial-stage company that provides molecular diagnostic tests for breast and metastatic cancers.
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Aptima HIV-1 Quant Dx Assay Receives Additional FDA Approval for Use as an Aid in the Diagnosis of HIV Infection
Hologic’s Aptima HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the United States.
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Hologic’s Genius Digital Diagnostics System for Cervical Cancer Screening Receives CE Mark
Genius Digital Diagnostics is the first digital cytology platform to combine a new artificial intelligence algorithm with advanced digital imaging to help identify precancerous lesions and cancer cells.
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HHS, DOD Award Hologic $119M Contract to Expand Covid-19 Testing Capacity
This investment will enable Hologic to expand production capacity to 13 million covid-19 tests per month by January 2022.
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Advancing the Diagnosis of Vaginitis
Two FDA-approved molecular testing platforms are leading to better targeted treatments for this common infection.
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FDA Amends EUA for Hologic’s Aptima SARS-CoV-2 Assay
The assay is now authorized for asymptomatic individuals and symptomatic sample pooling.
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HHS, DOD Invest $7.6M in Hologic to Expand Production for Covid-19 Tests
Under the contract, Hologic will expand production of custom sample collection and processing consumables for covid-19 tests.
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Hologic Launches Validated Pooling Protocol for Covid-19 Testing
By testing samples from multiple individuals simultaneously, pooling may help laboratories deliver accurate molecular test results more quickly.
Read MoreIMV ServiceTrak Awards for Clinical Laboratory Instruments
The 2020 ServiceTrak Clinical Laboratory Awards are based on interviews with respondents in 2,229 clinical testing locations having 5,117 instruments.
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AdvaMed Unveils National Covid-19 Testing Registry
AdvaMed has created a comprehensive, national covid-19 diagnostic supply registry to help state and federal governments in their pandemic responses.
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Avero Diagnostics Now Offering Covid-19 Testing
Avero will support the diagnostic needs of hospitals, health systems, multispecialty family practices, urgent care centers, and county health departments.
Read MoreFDA Issues Emergency Use Authorizations to Hologic and LabCorp
FDA has issued emergency use authorizations to Hologic for its Panther Fusion SARS-CoV-2 assay and to LabCorp for its Covid-19 RT-PCR test.
Read MoreHologic’s Molecular Test for the Novel Coronavirus, SARS-CoV-2, Receives FDA Emergency Use Authorization
Hospital, public health, and reference laboratories can perform the test on Hologic’s Panther Fusion system, a fully automated, high-throughput molecular diagnostic platform that is widely used across the United States.
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HHS Supports Development of High-Throughput Molecular Diagnostic for COVID-19
A COVID-19 diagnostic designed for use on a system that can process up to 1,000 tests in 24 hours will receive advanced development support from an HHS BARDA grant.
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FDA Clears Hologic Assays for Diagnosis of Vaginitis
Improved accuracy in identifying bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis will enable better targeted treatment for women.
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