Celltrion launches antigen and serology COVID-19 tests in the U.S., Verily adds capacity with CLIA lab and more
COVID-19 diagnostic developments this week include the addition of two types of COVID-19 rapid test kits by Celltrion and Verily’s move to boost capacity with a new CLIA lab in South San Francisco.
Celltrion Inc. (KSE:068270) is planning to launch antigen- and antibody-detecting test kits by next week; both are under FDA review for emergency use authorization (EUA). The antigen test, SAMPINUTE COVID-19 Antigen MIA, uses mAbs to detect the SARS-CoV-2 spike protein in nasopharyngeal swabs. The company said its has a 94% sensitivity and a 100% specificity; and can give results in 10 minutes.
As of Aug. 11, FDA had issued EUAs to only two antigen COVID-19 tests. The remainder of the 210 diagnostics with EUAs are molecular and antibody tests.
The Incheon, South Korean company’s other diagnostic, the DiaTrust COVID-19 IgG/IgM Rapid Test, takes 15 minutes to determine whether IgG or IgM antibodies against SARS-CoV-2 are present. Celltrion said the true-positive rates for IgM and IgG detection are 96% and 92%, respectively. The true-negative rates are 98.7% for IgM and 100% for IgG.
Separately, Verily Life Sciences LLC has established a CLIA-certified lab in South San Francisco to enable more COVID-19 testing; the company is launching the lab with a capacity of several thousand tests per day. According to Verily’s head of pathology, Deb Hanks, the lab uses the TaqPath test kit from Thermo Fisher Scientific Inc. (NYSE:TMO) to detect SARS-CoV-2 RNA; the kit has an EUA from FDA. Verily has submitted an EUA application to use the kit for pooled sample testing, Hanks said in an interview for Verily’s blog.
The surging demand for COVID-19 testing in the U.S. has resulted in delayed readouts, a problem the U.S. government is addressing by various means including NIH’s Rapid Acceleration of Diagnostics (RADx) program and pooled testing. On July 18, FDA granted the first EUA for a pooled COVID-19 test (see “EUA for Pooled Test”; “Pooled Tech as Way Out of Testing Crunch”).
CytoDyn seeking EUA
CytoDyn Inc. (OTCQX:CYDY) revealed that it has requested from FDA an EUA for leronlimab to treat mild to moderate COVID-19 based on data from the Phase II CD10 study.
The anti-CCR5 mAb led to a statically insignificant difference in the proportion of patients who had lower total symptom scores — the primary endpoint — at day 3 vs. placebo (90% vs. 71%).
Speaking on an investor call after market close Wednesday, President and CEO Nader Pourhassan said the clinically, but not statistically, significant difference supports use of the endpoint in a Phase III study in a larger patient population.
Pourhassan said leronlimab met a key secondary endpoint in the double-blind trial that evaluated disease severity via a different measure, the National Early Warning Score (NEWS). Half of patients given leronlimab had lower NEWS scores vs. 20% for placebo (p=0.0223) by end of treatment or day 14.
CytoDyn shares closed the week at $1.05, off 22%.