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antibody-based diagnostics

Representatives spoke to serology test accuracy, CLIA categorization of tests, and new sample types, among other issues.

Under a settlement, Yikon agreed to immediately stop advertising, marketing, and selling its serology test kits and to refund customers who purchased them.

Predictive Technology said its 15-minute antibody test for COVID-19 has shown a 92 percent sensitivity and 100 percent specificity.

The anti-SARS-CoV-2 antibodies for classes IgA and IgG are two of the first antibody detection tests to receive CE making and be made available for SARS-CoV-2 testing.

The firm said that its Affimer reagents may provide a better solution than antibodies in some applications for diagnostic test developers.

ARUP partnered with BioMarin to develop the blood-based assay, which is intended to identify those patients most likely to respond to the drug firm's AAV5-based gene therapy.

The antibody, called leronlimab, is a CCR5 antagonist under development by CytoDyn for a variety of indications including HIV and breast cancer.

The anticipated shortage for clinics comes at a time when more clinicians are already switching to lab-based IGRA testing, diagnostic industry executives said.

The VioOne HIV supplemental assay is for confirming and differentiating individual antibodies directed to various gene products of HIV-1 and HIV-2.

The company, which develops blood-based tests for cancer and autoimmune diseases, expects a second closing of the Series C round in Q2 of this year.