NEW YORK – Chembio Diagnostics said this week that it received a notice from the US Food and Drug Administration on Dec. 1 that additional data is needed for the firm's CLIA-waiver submission for its DPP HIV-Syphilis test system. Chembio had obtained FDA premarket approval for the system in October 2020.
In a Form 8-K filing with the US Securities and Exchange Commission, the point-of-care test developer said it is in discussions with the FDA about the agency's review of its CLIA-waiver submission and intends to comply with the FDA’s request. However, the company also noted that the amount of time it takes to seek additional data is unknown, and it cannot guarantee that it will be able to assemble the additional data requested by the FDA in a timely manner or at all.
The firm further noted in the SEC document that it had earned $12.5 million of the $12.7 million under an agreement inked in December 2020 with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority. The contract expired on Dec. 2, and $200,000, which was contingent on Chembio receiving an FDA Emergency Use Authorization for its DPP Respiratory Panel by Dec. 2, was unearned.
BioMérieux this week raised its growth estimate for full-year 2021 net sales to 8 percent at constant exchange rates and scope of consolidation. The company previously expected growth of between 4 percent and 7 percent. It attributed the increased estimate to stronger than expected sales of respiratory panels during the fourth quarter.
Danaher said this week that its board of directors has approved a quarterly cash dividend of $.21 per share of its common stock, payable Jan. 28, 2022, to shareholders of record on Dec. 30. The board also approved a quarterly cash dividend of $11.875 per share of its 4.75 percent Series A Mandatory Convertible Preferred Stock, payable Jan. 15, 2022, to shareholders of record on Dec. 31. In addition, the board approved a quarterly cash dividend of $12.50 per share of its 5 percent Series B Mandatory Convertible Preferred Stock, payable Jan. 15, 2022, to shareholders of record on Dec. 31.
Abbott said this week its board has increased the firm's quarterly common dividend 4.4 percent to $.47 per share. The dividend is payable Feb. 15, 2022 to shareholders of record at the close of business on Jan. 14, 2022.
Roche said this week that it has completed the repurchase of Roche shares held by Novartis. The corresponding consideration for the 53,309,000 repurchased shares has been transferred to Novartis, and the shares will be canceled once the corresponding procedure is completed. The repurchase is not expected to affect the full-year outlook, the company said.
Thermo Fisher Scientific said this week that it has completed its acquisition of clinical research services provider PPD for $17.4 billion. The transaction is expected to contribute $1.50 to Thermo Fisher's adjusted earnings per share in 2022.
Thermo Fisher said it expects to realize total synergies of approximately $125 million by year three following the close, consisting of approximately $75 million of cost synergies and approximately $50 million of adjusted operating income benefit from revenue-related synergies. In connection with the acquisition, Thermo Fisher will also assume approximately $3 billion in net debt from PPD.
PPD will now become part of Thermo Fisher's laboratory products and services business segment.
Castle Biosciences said this week that it has completed its acquisition of Cernostics, a company specializing in spatial biology and artificial intelligence-driven image analysis of tissue biopsies. Under the terms of the definitive agreement, Cernostics has become a wholly owned subsidiary of Castle Biosciences. At closing, Castle paid approximately $30 million in initial consideration to Cernostics security holders, which consisted entirely of cash. Up to an additional $50 million in cash and/or common stock is payable in connection with the achievement of certain milestones based on 2022 performance.
Oncocyte said this week that it has completed the second part of the technology transfer under its revised exclusive sublicense agreement with Chinese genomics firm Burning Rock Biotech, and has received a $2 million milestone payment. Per the agreement, Burning Rock has licensed Oncocyte's proprietary risk stratification test, DetermaRx, which it now plans to launch commercially in China.
Pattern Bioscience said this week its Pneumonia Action Panel has received breakthrough device designation from the US Food and Drug Administration. The test provides a fast and comprehensive diagnosis for patients hospitalized with severe pneumonia by leveraging its Digital Culture technology, which combines machine learning and single-cell analysis to provide pathogen identification and phenotypic antibiotic susceptibility information.
Co-Diagnostics this week announced that CoSara Diagnostics, its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization to manufacture and sell its Saraplex Flu A/Flu B/COVID-19 (ABC) RT-PCR test in that country. CoSara's test, based on its CoPrimer technology, is designed for the simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2.
Nanomix this week said that the UK's Medicines & Healthcare products Regulatory Agency has confirmed registration of the Nanomix eLab system and the S1 Panel Cartridge. Together, they provide multiple host-response biomarker results to aid healthcare providers in diagnosing and treating patients with infections such as sepsis. The panel cartridge measures C-reactive protein and procalcitonin, as well as lactate, and it is CE marked.
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.