The implementation of the In Vitro Diagnostic Regulation (IVDR) has significantly transformed the regulatory and operational ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of synthetic DNA using its silicon platform, ...

Diagnostic test developers, including clinical laboratories, responded to the COVID-19 pandemic with inspiring creativity to meet patient testing needs. These developers found unique ways to enable ...

Batch remains advantageous for development, variable demand, and bounded risk, benefiting from natural hold points, simpler investigations, and lower upfront capital, despite longer lead times and ...

Interested in learning more about assay design for primers and probes? Join us for this special Guardian of Your Science “Ask the Expert” webinar, hosted by field applications scientist Ben Avery. Ben ...

SARS-CoV-2 has created significant challenges for laboratories, requiring the development, validation, and scale up of testing in a very short time period--often this was done for multiple methods due ...

HILDEN, Germany & GERMANTOWN, Md.--(BUSINESS WIRE)--QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today a series of enhancements for its QIAcuity series of digital PCR (dPCR) ...

In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...

Approved biological products are required to be accompanied by analytical tests to demonstrate safety, purity, and potency. Manufacturing and testing processes for approved products are validated and ...

Assays are used in a diverse range of fields within the life sciences, and have become routine work in forensic, pharmaceutical, and microbiology labs. When designing an assay for any purpose, the ...