NEW YORK – Qiagen said on Wednesday that it has shipped its newly developed QiaStat-Dx Respiratory Panel 2019-nCoV test kit to four hospitals in China for evaluation. The new kit detects the novel coronavirus SARS-CoV-2 as well as 21 other targets for infectious agents causing respiratory disease. It runs on the company’s automated QiaStat-Dx system, which was CE marked in 2018 and cleared by the US Food and Drug Administration in mid-2019.
Qiagen said it has also begun shipping kits to public health institutions in Europe, Southeast Asia, and the Middle East. The company also said that it will apply for emergency authorization for marketing of the new panel with the FDA, the Korean KCDC/MFDS, and China’s National Medical Products Administration. The panel is expected to be available with CE-IVD marking in Europe and other markets.
PerkinElmer disclosed in its Form 10K this week that it reduced its headcount in 2019 by 430 and took restructuring charges of $29.4 million related to the reduction. The company recorded restructuring charges of $7.6 million in its Diagnostics segment and $21.8 million in the Discovery and Analytical Solutions segment.
PerkinElmer also said that it acquired five businesses in 2019 for an aggregate consideration of $433.1 million, including Cisbio Bioassays for $219.9 million in cash and Shangdong Meizheng Bio-Tech for $166.5 million in cash.
Stilla Technologies said this week that it is donating two of its Naica digital PCR systems to the City of Zhengzhou and City of Xinyang in China to help officials there detect SARS-CoV-2 and monitor mutations in the coronavirus. Paris-based Stilla said that Cycloud and Apexbio, its distributors and business partners in China, will offer technical support, reagents, and kits.
Novacyt this week announced that Primerdesign, its molecular diagnostics division, had sold CE-marked and research-use-only COVID-19 tests worth more than £930,000 ($1.2 million) as of Feb. 27.
Primerdesign has signed its first distribution agreement with a global life sciences company to supply the COVID-19 test to two Asian territories outside mainland China. Revenues are anticipated to be £2.1 million during the first six months of the agreement, and first sales are expected to occur in March, Novacyt said.
The firm added it is in discussions with representatives from "a number of countries" that have an acute need for tests as part of their national screening programs.
The Primerdesign test is under review by the US Food and Drug Administration for Emergency Use Approval that would allow it to be used for clinical diagnosis of COVID-19 in the US.
Prognos Health this week launched the Rare Disease Institute (RDI), a collaborative initiative focused on improving testing, diagnosis, and treatment of rare diseases. Collaborators include Antidote Technologies, Blueprint Genetics, the Cure GM1 Foundation, Datavant, the Medical College of Wisconsin Genomic Sciences & Precision Medicine Center, PWNHealth, and the United Leukodystrophy Foundation.
The RDI is planning to partner with pharmaceutical companies, reference and genetic testing labs, health systems, academic centers, patient advocacy groups, and technology companies to improve access to testing and therapies for patients, educate patients and physicians on available diagnostics, and help the pharmaceutical industry develop new therapies for rare diseases.
Toronto-based SQI Diagnostics said this week that total revenues for its fiscal first quarter of 2020 declined 29 percent to C$207,000 ($154,000) from C$292,000 a year ago. For the recently completed quarter, the firm recorded C$147,000 from product sales, including C$136,000 in kit sales and C$60,000 in service revenues.
Its R&D costs rose 25 percent to C$1.1 million from C$877,000 a year ago. Its corporate and general expenses increased 12 percent to C$364,000 from C$324,000, and its sales and marketing expenses shrank 20 percent to C$259,000 from C$325,000.
SQI had a net loss of C$2.0 million, or C$.01 per share, for Q1 2020 compared to a net loss of C$1.8 million, or C$.01 per share, a year ago.
Thermo Fisher Scientific announced this week that its board authorized a quarterly cash dividend of $.22 per share, payable on April 16 to shareholders of record on March 16.
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