NEW YORK – Natera said this week that it has launched a multi-site prospective study to externally validate a new algorithm for its Prospera donor-derived cell-free DNA transplant rejection test. The PEDAL (Prospera Test Enhancement by Detecting Background Cell-Free DNA Levels) study will enroll 500 kidney transplant patients at 20 major centers in the US and will start recruitment soon. It aims to assess the performance of the assay to detect rejection, the prognostic ability of cfDNA at the time of biopsy, and the performance of the assay to detect clearance of rejection after treatment.
Twist Bioscience said this week that it has joined an international alliance led by Singapore-based Proteona, to develop antibody therapies for COVID-19. Twist will synthesize and express the sequences for potential antibody therapies, which will be tested by collaborators in animal and cell studies for safety and efficacy. Twist has synthesized sequences for potential COVID-19 antibody therapies for the Vanderbilt Vaccine Center, and has discovered its own antibody candidates for the disease.
Novacyt said this week that its Primerdesign business unit has been awarded a contract from the Zimbabwe's Ministry of Health and Child Care for the supply of 1.5 million SARS-CoV-2 tests. The company added that it has received a purchase order for the first 500,000 tests and will ship them immediately. It anticipates shipping the remaining 1 million tests over the coming weeks.
During the last few weeks, Novacyt secured registrations and regulatory approvals for the test in Panama, Ecuador, Columbia, Peru, Paraguay, and the United Arab Emirates. However, Haute Autorité de Santé (HAS) has not approved Primerdesign's test for reimbursement in France, Novacyt said. HAS is refusing to authorize reimbursement because the test detects a single-gene target. Novacyt can still sell the assay for private patient testing in France, the company said.
Separately, the firm said this week that it will settle all outstanding debt obligations, which amount to €7.0 million ($7.9 million), with Harbert European Growth Capital and Vatel Capital, before the end of June.
Canadian life sciences firm Microbix Biosystems said this week it has received a CE mark for its SARS-CoV-2 quality assessment products, which include whole-genome controls for molecular testing for the coronavirus. The controls are compatible with commercial lab instruments, lab-controlled manual test systems, and point-of-care based test systems. Microbix's distributors covering 18 EU countries can provide the products to clinical labs across the region.
Microbix has also appointed Alpha-Tec Systems as the distributor of its quality assessment products in the US and Latin America, the companies said. Vancouver, Washington-based Alpha-Tec, a subsidiary of Calibre Scientific, provides reagents, tools, instruments, and other consumables to the lab research, diagnostics, industrial, and biopharmaceutical industries. The distributed products include Microbix's REDx FLOQ SARS-CoV-2 RT-PCR test control, the only control available on a COPAN FLOQ Swab.
Biocept said this week that it is relocating its CLIA-certified, CAP-accredited high-complexity laboratory to a new location in San Diego, a move that should be complete by the end of this year. The firm's new 39,000-square-foot headquarters, manufacturing, and lab facility will be located at 9955 Mesa Rim Road, San Diego, CA.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.