Abnova & Assurance Scientific Received FDA Clinical Laboratory EUA Approval for its COVID-19 Viral Extraction Kit

Neihu, Taiwan (June 17, 2020)

Abnova announced today that Abnova and its partner Assurance Scientific Laboratories have gained FDA EUA approval for its COVID-19 viral extraction kit for clinical laboratory usage. Viral RNA extraction is a mandated procedure prior to the COVID-19 RT-PCR detection assay. Both Abnova and Assurance Scientific have established a standardized operating protocol of COVID-19 isolation, extraction, and identification for use under the clinical laboratory setting. Currently, majority of the COVID-19 viral testing in the US is being performed in the clinical laboratories under US CLIA certification as a high complexity test.

Prior to the EUA approval, Abnova has been supplying the general extraction kit to Assurance Scientific under a research use only (RUO) label. As a result of COVID-19 outbreak, Abnova and Assurance Scientific have worked closely together in the last three months to optimize the COVID-19 extraction and satisfy the preclinical and clinical testing required by the FDA EUA certification. The EUA approval has catapulted Assurance Scientific’s purchase order and Abnova’s sales of the COVID-19 viral extraction kit. Just this week, Abnova has captured the largest single order from Assurance Scientific with significant contribution to its revenue.

Abnova’s COVID-19 viral extraction kit is based on the principle of magnetic bead-based RNA extraction. The quality and purity of the RNA products are essential to the downstream RT-PCR assay for COVID-19 viral detection and identification. The RT-PCR assay has become a gold-standard test world-wide since the COVID-19 outbreak. Abnova and Assurance Scientific have been a long-term, collaborative partner in the extraction kits for multitude of applications. Due to the recent COVID-19 outbreak, Abnova’s kit was successfully applied, validated, and EUA-approved for COVID-19 RNA extraction.