The news from Quanterix Corp. has come fast and furiously this week. The company reported that Chairman and CEO Kevin Hrusovsky will step down on April 25 and become executive chairman of the board, while current company President Masoud Toloue will assume the CEO position and join the board of directors. Hrusovsky became CEO in 2014 and Toloue joined Quanterix in June 2021 from Perkinelmer Inc. The company also revealed that it has built on its collaboration with Indianapolis-based Eli Lilly and Co. for new tools to diagnose, monitor and treat Alzheimer’s disease (AD) and presented its fiscal 2021 financial results, which showed a 28% increase in total revenue, largely attributable to its neurology segment.
Fujirebio Europe NV launched two new cerebrospinal fluid (CSF)-based immunoassays for Alzheimer’s Disease (AD) on its Innotest platform. It’s the first product launch for the company following a collaboration agreement signed with Adx Neurosciences NV in September 2020. The assays will test for neuronal pentraxin-2 (NPTX2) and soluble triggering receptor expressed on myeloid cells 2 (STREM2). Both neurology biomarkers are linked to synaptic dysfunction and neuroinflammation which are considered core features of AD progression. Fujirebio said the new tests will support existing research for AD drug development.
Perkinelmer Inc. has agreed to acquire in vitro diagnostics company Immunodiagnostic Systems Holdings plc (IDS) for approximately $155 million (£110 million). The deal will enable Perkinelmer to expand its overall diagnostics business, particularly the immunodiagnostics segment. Based in Boldon, U.K., IDS makes chemiluminescence products in endocrinology, autoimmunity and infectious diseases. The company has three operating business units: Automated IVD Business, Manual IVD Business and Licensing and Technology.
Following steady expansion of its base among global pharmaceutical companies, Correlia Biosystems Inc. has secured the capital needed to make its nanotechnology-based immunoassay platform commercially available. The company received an infusion of $7 million in series A financing in a round led by Neotribe Ventures with participation by Cota Capital, the Regents of the University of California and others.
HONG KONG – Incheon, South Korea-based Celltrion Inc. is planning to launch two of its three rapid test kits in the U.S. as it plays its part in the global fight against the COVID-19 pandemic. Celltrion said Aug. 12 that its Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM rapid test kits will launch in the U.S. by the third week of August.
The next phase of testing for the COVID-19 pandemic will hopefully include the roll-out of tests for neutralizing antibodies for the SARS-CoV-2 virus, but there are some roadblocks. The FDA’s Tim Stenzel said the agency has a limited amount of information to offer regarding emergency use authorizations for these tests, a predicament that might not resolve until several applicants are in and the agency can see some information that will aid in development of performance and validation standards.
Widespread testing is going to be key to safely reopening businesses and global economies in the current pandemic. To that end, Kahala Biosciences LLC, an Irvine, Calif.-based testing and tracking startup, and its technology partner, Rymedi Inc., of Greenville, S.C., have launched the Adiona COVID-19 antibody testing platform, combining antibody testing with a blockchain-enabled smartphone app to increase predictability and traceability of potential outbreaks.
LONDON – Lateral flow diagnostics specialist Mologic Ltd. has teamed up with Biosure Ltd., manufacturer of the only CE approved HIV home testing kit, to produce a COVID-19 antibody self-test. The companies are combining Mologic’s validated IgG antibody lateral flow strip with Biosure’s test kit, and say the product will be ready for mass production at the beginning of June.
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.
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.
