COVID-19 roundup: Qiagen, BD-BioMedomics, Rendu, Vaxart, Cobra, GigaGen, Houston Methodist, Anaqua-WideTrial

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FDA’s emergency use authorization for a Qiagen test Tuesday comes amid a flurry of advancements in therapeutic, vaccine and diagnostic COVID-19 programs, including GigaGen’s unveiling of a polyclonal antibody program derived from convalescent COVID-19 patients.

The test from Qiagen N.V. (Xetra:QIA; NYSE:QGEN) can produce results in about one hour. The QIAstat-Dx Respiratory SARS-CoV-2 Panel is a multiplexed nucleic acid-based diagnostic that differentiates COVID-19 from 20 other serious respiratory infections by detecting two SARS-CoV-2 genes.

Meanwhile, Becton Dickinson and Co. (NYSE:BDX) and BioMedomics Inc. released a point-of-care test that can identify antibodies against SARS-CoV-2 in 15 minutes. Henry Schein Inc. will distribute the test, which can detect ongoing or resolved COVID-19, in the U.S.

Also passing a regulatory hurdle was a SARS-CoV-2 nucleic acid kit from Rendu Biotechnology, which gained emergency approval from China’s National Medical Products Administration (NMPA). In Rendu’s assay, genome extraction and nucleic acid amplification take place in a single tube, and the test reads out in 90 minutes. The company simultaneously launched AutoSAT, an automated high-throughput platform that’s compatible with the kit.

And to alleviate shortfalls in U.S. diagnostic capabilities, the Innovative Genomics Institute (IGI) announced plans to establish an automated COVID-19 testing lab on the University of California Berkeley campus. The IGI testing lab is starting with FDA-approved RT-PCR tests and will soon conduct 1,000 tests per day, with the ability to run 3,000 tests per day. It will provide results to healthcare workers within 12-24 hours of sample collection. IGI is a San Francisco Bay Area-based research partnership founded by Jennifer Doudna.

Viral vaccines queuing up

Vaxart Inc. (NASDAQ:VXRT) announced it has five oral COVID-19 vaccine candidates in preclinical testing to pick its clinical candidate. Each of Vaxart’s vaccine constructs, from its adenovirus serotype 5 (Ad5)-based VAAST platform, delivers genes encoding a different combination of SARS-CoV-2 antigens. The company expects to enter the clinic early next half, with partner Emergent BioSolutions Inc. (NYSE:EBS) expected to produce bulk cGMP vaccine for use in the study.

CDMO Cobra Biologics said that it, as part of a consortium led by Oxford University’s Jenner Institute to develop adenoviral COVID-19 vaccine candidate ChAdOx1, is planning a rapid set-up phase to enable efficient GMP production of the vaccine. Clinical testing of ChAdOx1, which could be the U.K.’s first COVID-19 vaccine, is slated to begin in April.

Full antibody repertoire

GigaGen Inc. unveiled on Monday its recombinant polyclonal antibody treatment for COVID-19, recombinant anti-coronavirus hyperimmune gammaglobulin (rCIG). The company generates rCIG using its single cell technology for recreating the antibody repertoire of individuals who have recovered from COVID-19, and can therefore circumvent the need to continually acquire convalescent plasma donations. GigaGen is recruiting donors for rCIG production, and hopes to enter the clinic in early 2021.

Houston Methodist said FDA approved on Saturday an emergency IND to treat a critically ill COVID-19 patient with convalescent plasma donated by a recovered COVID-19 patient.

FDA released guidance on March 24 to help physicians provide convalescent plasma to COVID-19 patients on a compassionate use basis while acknowledging that the safety and efficacy of the approach has not been established in clinical trials (see “FDA Facilitating Compassionate Use”).

Separately, Anaqua Inc., via its ideaPoint product for medical affairs solutions, and WideTrial partnered Tuesday to set up an internet-based platform for COVID-19 therapeutic developers to make their products available, if applicable, under expanded use programs. Through the online system, healthcare providers can sign up to participate in expanded use program of their choice.

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