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In Brief This Week: Quest Diagnostics, Novacyt, Natera, and More

NEW YORK – In a document filed with the US Securities and Exchange Commission this week, Quest Diagnostics said that since reporting its first quarter results in April, its base business — which excludes COVID-related testing — has recovered more quickly than it had anticipated, and testing volume is higher in areas in the US where state and local governments are lifting restrictions on business activity. If this continues and COVID-19 molecular and antibody testing trends continue, the company believes its adjusted EPS for the second quarter may be in the break-even to slightly profitable range.

However, Quest also noted that since the announcement of its Q1 results, it continues to see a material decline in its testing volumes due to the coronavirus pandemic. The adverse impact of the pandemic on Quest's operating results, cash flows, and/or financial condition will be driven by the pandemic's severity and duration, its impact on the US healthcare system and economy, and the timing and scope, as well as effectiveness, of federal, state, and local responses to the pandemic, which are beyond the firm's knowledge and control, the firm added.

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.

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.

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.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.

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