NEW YORK – Qiagen said this week that it is drastically ramping up global production capacity for its RNA extraction kits used in the development of molecular diagnostic tests for SARS-CoV-2, the virus causing the global COVID-19 pandemic. Previously, there were widespread reports about shortages in the extraction kits causing delays in test development, one of several pain points labs have encountered in their efforts to ramp up COVID-19 testing. Qiagen said that it has historically allocated global production capacity to manufacture RNA extraction reagents to supply about 1.5 million patient tests per month. Now, the firm said it is ramping up production capacity to support more than 6.5 million tests per month by the end of April, and more than 10 million tests per month by the end of June. Qiagen said that a significant capacity expansion project is underway at sites in Europe and the US to reach more than 20 million patient tests on a monthly basis by the end of 2020.
Gingko Bioworks this week said that it will offer $25 million worth of free access to its platform to partner on projects related to SARS-CoV-2. The range of projects includes those directed at the development of point-of-care diagnostics, as well as vaccines and therapeutics. Gingko Bio’s capabilities in the area of POC diagnostics include the rapid discovery of enzymes that may improve CRISPR-Cas-based nucleic acid diagnostics; a protein engineering pipeline to improve parameters such as diagnostic specificity and selectivity and overall robustness; the synthesis of swap-in, swap-out guide RNA components for CRISPR-Cas-based devices; and the ability to scale protein expression. The firm added that it can leverage its next-generation sequencing platform to provide viral sequencing of about 10,000 samples a day and synthesize gene length fragments of the coronavirus in various expression formats.
Nvidia said this week that it is offering a free 90-day license for its recently acquired Parabricks sequencing analysis software to any researcher sequencing the SARS-CoV-2 genomes or genomes of patients affected by COVID-19. The company said that it may extend the offer as needed.
Details on how to register are available on Nvidia's blog.
JN Medsys announced this week that its ProTect Covid-19 kit has received provisional authorization from Singapore's Health Sciences Authority (HSA) for in vitro diagnostic use. The ProTect kit is a nucleic acid test that identifies the genetic material of the SARS-CoV-2 virus isolated from infected patient samples using reverse transcription quantitative PCR. The company is aiming to get regulatory approvals for the kit in Europe and elsewhere.
It also has a version of the Covid-19 kit that works on its Clarity digital PCR system, which can provide absolute quantification of the Sars-CoV-2 virus.
BioReference Laboratories this week announced a partnership with the State of New Jersey to provide SARS-CoV-2 testing for the state's first five drive-through testing facilities. The company is expanding testing by offering an additional 10,000 tests to New Jersey residents.
Last week the company struck a similar deal with the New York State Department of Health to provide testing for drive-through testing sites throughout the state.
Swiss lab firm Unilabs said this week it has set up a drive-through facility to collect patient samples for SARS-CoV-2 testing. The temporary facility is based in Porto, Portugal and will take pressure off hospitals as they try to manage the large volume of patients requiring testing, Unilabs said. About 400 tests per day will be performed initially, eventually rising to 700 tests per day in the coming days.
Danaher announced this week that the US Federal Trade Commission has accepted the proposed consent order related to the company’s acquisition of GE Life Sciences' Biopharma business. The FTC's acceptance satisfies the required antitrust clearances for the acquisition. Danaher said it expects the acquisition to close on March 31.
NantHealth said this week that it has reached a proposed settlement with shareholders in a 2017 class action lawsuit brought over the firm's stock price. Under the terms of the deal, the company will pay $16.5 million to resolve claims about allegedly misleading statements by NantHealth executives and directors regarding demand for the firm's services in the days leading up to an initial public offering on June 2, 2016. NantHealth has not admitted to any wrongdoing.
Several law firms filed class action suits in March 2017, alleging the company made false and misleading statements in connection with its IPO. This settlement covers the Deora v. NantHealth case, filed March 7, 2017, in the US District Court for the Central District of California. The court has scheduled a hearing on June 15 to decide whether to approve the settlement.
Aytu BioScience said this week it has extended its distribution right to commercialize a point-of-care SARS-CoV-2 immunoassay to include Mexico. Aytu, a specialty pharmaceutical firm, licensed the US rights to the test from Hong Kong's LB Resources. The test was developed by Zhejiang Orient Gene Biotech.
PreCheck Health Services this week announced an agreement with Co-Diagnostics for the distribution of that firm’s Logix Smart COVID-19 PCR test and CoDx Box instrument in Romania and Moldova. It previously reached deals with Co-Diagnostics to distribute the test and instrument in Russia, Ecuador, and Panama.
Co-Diagnostics announced this week that CoSara Diagnostics, its joint venture for manufacturing in India, has become the first company in India to receive a license from the Central Drugs Standards Control Organization to manufacture RT-PCR COVID-19 test kits. The kits are expected to be sold on the Indian market, as well as for export to the surrounding regions.
Exagen announced this week that it has entered a strategic partnership with Sonora Quest to offer preferred access to its AVISE testing to patients in Arizona. The testing provides diagnosis, prognosis, monitoring, and therapeutic options for patients with autoimmune rheumatic disease. Testing will be available through healthcare provider customers of Sonora Quest starting in spring 2020. Financial and other terms of the agreement were not disclosed.
Sight Diagnostics said this week it has partnered with Sheba Tel Hashomer Hospital in Israel to deploy Sight’s OLO blood analyzer to provide rapid complete blood count results in a dedicated coronavirus lab within the hospital, to process samples of infected patients who are being monitored and treated in a separate field hospital.
Prior to deploying OLO for coronavirus patient testing, Sight said it ran a two-month evaluation at Sheba Tel Hashomer's central lab. OLO is currently being used for routine CBC testing of Sheba’s positive coronavirus patients.
Agilent Technologies said this week that it will pay a quarterly dividend of $.18 per share of common stock on April 22 to all shareholders of record as of the close of business on March 31.
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.