Quanterix Corp., of Billerica, Mass., reported that researchers have developed a COVID-19 antibody test with 1,000 times the sensitivity of current tests using its Simoa bead-based immunoassay platform.
Abbott Laboratories received FDA emergency use authorization (EUA) for its COVID-19 molecular test, which will run on the company's new Alinity m system, as well as its COVID-19 antibody blood test, which will run on the Alinity i system. The two actions bring to five the number of COVID-19 tests developed by the Abbott Park, Ill.-based company to receive EUAs.
As states in the U.S. move past the initial push for tests to identify active COVID-19 infections, antibody tests are ramping up quickly to aid in disease surveillance and return-to-work screenings. The rush has spurred an explosion in serology tests, many hastily developed and of questionable value. However, as the pandemic enters its third month, some companies are offering high-accuracy tests with validated results.
The U.S. FDA continues to modify its emergency use authorization (EUA) policy for testing for the SARS-CoV-2 virus, although workplace testing is still on the agency’s to-do list. The FDA’s Tim Stenzel noted on a May 6 briefing that serological tests for antibodies must now demonstrate an overall sensitivity of 90% and overall specificity of 95%, a set of standards that might challenge some tests that are available under the EUA policy.
BEIJING – In one of the latest Sino-foreign collaborations formed to find a cure for the pandemic that has infected 3.5 million people worldwide, Shanghai-based Junshi Biosciences Co. Ltd. and Eli Lilly and Co. have disclosed an agreement to co-develop therapeutic antibodies for preventing and treating COVID-19. Under the terms, Junshi grants Lilly an exclusive license, outside of greater China, to conduct R&D, manufacture and distribute the SARS-CoV-2 JS-016 neutralizing antibodies developed by Junshi.
LONDON – These are hardly times for a fanfare, but this month saw the unveiling of a new name in bioprocessing, following the formal closing of the $21.4 billion sale of GE Healthcare’s Life Sciences to Danaher Corp. The business, now renamed Cytiva, has turnover of $3.3 billion, nearly 7,000 employees and operations in 40 countries. More than 75% of FDA-approved biologic drugs use its products in their manufacture.
DUBLIN – Ethris GmbH and Neurimmune AG have formed a collaboration to develop nebulized, mRNA-encoded monoclonal antibodies directed at SARS-CoV-2, which will be delivered directly to the lungs of patients with COVID-19.
Proteona Pte. Ltd. has formed a couple of significant partnerships recently, including a Germany-Singapore partnership for a drug screening and discovery platform using single cell multi-omics analysis and an alliance to develop antibodies against coronaviruses.
BEIJING – Suzhou-based Innovent Biologics Inc. has inked a deal with Alector Inc. to obtain the rights of the U.S. biotech’s AL-008 to develop and commercialize it for oncology indications in China.
BEIJING – Suzhou-based Innovent Biologics Inc. has inked a deal with Alector Inc. to obtain the rights of the U.S. biotech’s AL-008, a dual function anti-SIRP-alpha (anti-signal regulatory protein-alpha) antibody, to develop and commercialize it for oncology indications in China.