Compact genetic testing device created for Covid-19 could be used to detect a range of pathogens, or conditions including cancer A virus diagnosis device that gives lab-quality results within just ...

Because of its high accuracy, laboratory-based polymerase chain reaction (PCR) testing is the gold standard for infectious disease diagnostics. However, PCR technology requires highly trained staff ...

Researchers and graduate students at the University of Alabama at Birmingham are developing a new at-home cervical cancer screening device aimed at increasing access to screening and improving early ...

Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs). The five stages of the ...