FDA Approves EUA Amendment Increasing Applied DNA’s COVID-19 Diagnostic Kit Testing Capacity Through Use of Automated RNA Extraction and Expands Supported Platforms
Applied DNA Sciences, Inc. (APDN)
Last applied dna sciences, inc. earnings: 8/10 04:05 pm
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Source: Business Wire
- Diagnostic Kit Authorized for Use on Widely Installed RT-PCR Device and High-Throughput RNA Extraction Robotics; Company Ramps Kit Production in Response - STONY BROOK, N.Y.--(BUSINESS WIRE)--Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, and pre-clinical nucleic acid-based therapeutic drug candidates, today announced that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) amendment that both expands the installed base of PCR equipment platforms that can process the Company’s LineaTM COVID-19 Assay Kit and introduces automation to significantly increase the throughput of the assay by use of robotic RNA extraction.The EUA amendment extends the RT-PCR platform authorization from the Applied Biosystems (ThermoFisher Scientific) QuantStudio™ Dx to include Applied Biosystems’ QuantStudio™ 5 Real-Time PCR system (“QS
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APDN
Earnings
- 2/8/24 - Beat
APDN
Sec Filings
- 4/24/24 - Form S-1
- 4/23/24 - Form 8-K/A
- 4/22/24 - Form 8-K
- APDN's page on the SEC website