Saladax Biomedical’s FDA-Cleared Clozapine Assay
The FDA-cleared clozapine assay seeks to redefine the landscape of clozapine therapeutic drug monitoring and patient management.
Category: Rapid Assays
Rapid Assays
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Rapid Assays
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Cancers & Heart Disease May be Easier to Diagnose Via New Rapid Test
Researchers have built a new, easy-to-use test that could diagnose non-infectious diseases like heart attacks and cancers more quickly.
Rapid Assays
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Center Creating Rapid Next-Gen Medical Tests Wins $6.6M NIH Funding
The Center of BioModular Multi-Scale Systems for Precision Medicine creates rapid tests for human ailments like cancer, stroke, and COVID.
Portable Prostate Cancer Test Aims to Reach Underserved Men
A portable and rapid prostate cancer screening kit could provide early warning to populations with higher incidence of prostate cancer.
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COVID-19 Vaccination May Trigger False Reactivity in Certain RPR Test
The FDA alerted that false reactivity Rapid Plasma Reagin test results in a Bio-Rad RPR kit can occur for some who received a COVID-19 vaccine.
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LumiraDx Offers At-Home, Self-Collection Kit for COVID Test Solution
LumiraDx’s SARS-CoV-2 assay will now offer a self-collected COVID-19 nasal specimen collection kit through a new partnership with Audere.
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COVID-19 Rapid Antigen Tests More Effective Than Expected
A new study found COVID-19 rapid antigen detection tests proved more effective than expected when compared to the polymerase chain reaction (PCR) assay.
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FDA Reissues High Throughput COVID-19 Testing Solution for Emergency Use
The LumiraDx SARS-CoV-2 RNA STAR Complete has been authorized by FDA for emergency use under an EUA for use by authorized laboratories.
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Anitoa Receives FDA 510(k) Clearance for Portable qPCR Instruments
The Maverick line of qPCR instruments from Anitoa Systems has received U.S. FDA registration and device listing as class II 510(k) exempt medical devices.
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Emphasis on Halting COVID Should Be On The Testing Type
While welcoming a renewed emphasis on testing, some healthcare leaders warn that America’s path forward requires balancing testing speed with accuracy.
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DRUL Saliva Test Accuracy for COVID-19 May Surpass Swab
Rockefeller University’s “DRUL” saliva test performs as well as, if not better, than FDA-authorized nasal and oral swab tests.
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Visby Medical Receives FDA Clearance for Sexual Health Test
Visby Medical has received a 510(k) clearance to market its fast, single-use PCR diagnostic test for the detection of STIs.
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BD Receives EUA for At-Home COVID Test Using Smartphone
BD has announced the U.S. FDA has issued an Emergency Use Authorization (EUA) for the BD Veritor At-Home COVID-19 Test.
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Updated Versions of LAMP Reagents Introduced
New England Biolabs (NEB) has released its newest loop-mediated isothermal amplification (LAMP) products, allowing for rapid, high throughput tests.
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QIAGEN Receives FDA EUA for Rapid COVID Test
QIAGEN has received emergency use authorization (EUA) from the FDA for its QIAreach SARS CoV-2 Antigen Test.
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Acupath Laboratories Providing COVID Testing for Airlines
Acupath is part of a select group of laboratory providers in the greater NYC area meeting the COVID-19 testing needs for international travel.
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COVID-19 Travel Kit Allows for a Rapid Return Home
CityHealth, a provider of urgent care and COVID testing solutions, has launched a COVID testing solution for travelers.
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iXensor Launches COVID-19 Ag Test Data Management Platform
iXensor Co., Ltd. has launched a new version of its integrated COVID-19 screening solution, the PixoHealth Pass Admin App and Web Portal.
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