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In Brief This Week: Qiagen, FDA, Yourgene, and More

NEW YORK – In separate lawsuits filed against Qiagen and several of its executives in the US District Court for the Southern District of New York this month, two of the company’s shareholders are alleging that Qiagen violated federal securities laws in relation to its planned acquisition by Thermo Fisher Scientificannounced in early MarchSpecifically, plaintiffs Robert Capka and Milton Pfeiffer are alleging that Qiagen issued a solicitation/recommendation statement with the US Securities Exchange Commission on May 18 that is materially deficient and misleading because it fails to disclose material information about the company’s financial projections, financial analyses conducted by the board's financial advisors, the terms of confidentiality agreements with other potential acquirers, and communications regarding the employment of Qiagen management that took place prior to entry into the merger agreement. The lawsuits note that the acquisition offer from Thermo Fisher is scheduled to expire on July 27, and that it is "imperative that the material information … is disclosed to the company's stockholders prior to the expiration time so they can properly determine whether to tender their shares."

In a virtual town hall with assay developers this week, the US Food and Drug Administration announced that it has updated its "What Tests Should No Longer Be Distributed for COVID-19?" FAQ page with additional antibody assaysThe list of de-listed tests had initially included 27 tests but has since been updated to 29 assays. The manufacturers of these tests either did not submit an Emergency Use Authorization application in time, had significant flaws in test validation, or voluntarily withdrew notification.

Yourgene said this week that its testing laboratories have launched a COVID-19 testing service, aimed at defined populations such as UK GP surgeries, private clinics, and corporate clients in the UK. The company is also developing its first infectious disease test — the Clarigene SARS-CoV-2 test, a molecular COVID-19 PCR assay with a rapid turnaround time and high sensitivity. It plans to release a research-use-only version of the test by the end of June and a CE-marked in vitro diagnostic kit in July. Initially, the test will be a manual assay but Yourgene is working on a fully automated version for high-throughput laboratories. It plans to sell the CE-IVD kit to other labs and to run the test in its own service laboratory.

Yourgene also said that its core molecular diagnostics business continues to perform in line with management expectations. It remains confident of receiving the CE mark for its Illumina-based Iona test in the near future and plans to announce its financial results for its fiscal year, which ended March 31, by the middle of July.

SQI Diagnostics this week reported a 36 percent drop in its year-over-year fiscal second quarter revenues. 

For the quarter ended March 31, the Toronto-based life sciences and diagnostics firm posted revenues of C$269,000 ($195,224) compared to C$419,000 a year earlier. Its fiscal Q2 product revenues, including revenues from kit sales, fell 60 percent to C$115,000 from C$287,000 in Q2 2019, and its Q2 services revenues rose 17 percent year over year to C$154,000 from C$132,000. 

The company said that during Q2, University Health Network validated its TORdx Lung assay in the operating room at Toronto General Hospital. The firm received a Canadian Institutes of Health Research grant to support the initiation of various COVID-19 and respiratory infection studies with UHN, and it received New York State Department of Health approval for its rheumatoid arthritis direct-to-consumer test. 

SQI posted a fiscal Q2 net loss of C$2.3 million, or C$.01 per share, compared to a net loss of C$1.6 million, or C$.01 per share, in Q2 2019.  

Its fiscal Q2 R&D expenses were C$1.2 million, up 73 percent year over year from C$695,000. SQI's fiscal Q2 corporate, general, sales, and marketing expenses were C$828,000, up 20 percent year over year from C$689,000 a year earlier.

Beckman Coulter Life Sciences said this week that its RNAdvance Viral XP extraction kit has been added to the US Food and Drug Administration’s list of acceptable extraction methods for the US Centers for Disease Control and Prevention’s SARS-CoV-2 test. Laboratories can now independently validate the kit for use.

Care management organization Home State Health this week announced a collaboration with Quest Diagnostics to increase access to RT-PCR COVID-19 testing in critical areas of need in St. Louis, Missouri. Home State said that it will facilitate the distribution of up to 1,000 Quest COVID-19 test kits each week to Affinia Healthcare and People's Health Centers federally qualified health centers. 

Home State said the collaboration leverages its network of critical safety-net providers to ensure that testing capacity is routed to where it is needed most. The organization will provide oversight and training to ensure test kits are received and processed efficiently. Distribution of kits began on May 6Quest Diagnostics will conduct the COVID-19 testing through its network of laboratories across the US.

Genetic Technologies said this week that it has closed its previously announced public offering of 3.5 million American Depositary Shares (ADSs) and 500,000 pre-funded warrants, for aggregate gross proceeds of approximately $8 million.

Each ADS represents 600 of the Australian molecular diagnostic firm's ordinary shares. The company sold the ADSs at an effective purchase price of $2 each and the warrants at an effective purchase price of $1.9999 per pre-funded warrant. Each pre-funded warrant sold in this offering is exercisable into one ADS at an exercise price of $0.0001 per ADS, Genetic Technologies added.

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.