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In Brief This Week: Thermo Fisher Scientific, Quanterix, BGI, Illumina, and More

NEW YORK – Thermo Fisher Scientific said this week that it will be donating $15 million in diagnostic instruments, test kits, and related supplies to support efforts at historically black colleges and universities (HBCUs) to make COVID-19 testing available to all returning students. The firm said it will also provide technical assistance to HBCUs that want to establish or expand their labs to provide regular COVID-19 testing throughout the 2020-2021 school year. Howard University, Morehouse School of Medicine, Meharry Medical College, Xavier University of Louisiana, and Hampton University will be among the first HBCUs to receive donations, Thermo Fisher said.

Quanterix said this week that it closed its previously announced underwritten public offering of 3,048,774 shares of its common stock at an offering price of $32 per share, including 397,666 shares sold in accordance with the full exercise of the underwriters’ option to purchase additional shares.

Gross proceeds from the sale of the shares were approximately $97.6 million. SVB Leerink and Cowen were joint bookrunning managers for the offering. Canaccord Genuity was the co-manager.

New York Governor Andrew Cuomo's office said this week that the State University of New York has been approved by the New York State Department of Health to perform pooled surveillance testing for COVID-19. The pooled testing method was developed and validated by SUNY Upstate Medical University's laboratory and Quadrant Biosciences. It will use saliva samples, pooled in batches between 10 and 25 samples. Individuals will be able to administer the test themselves by swabbing their mouths and providing the saliva sample to medical personnel. A negative sample would mean each individual whose samples were pooled in the batch are presumed to be negative for COVID-19. If a test comes back positive, each individual in the batch would need to be individually tested with a PCR-based test. 

BGI said this week that it has been granted a partial stay of a preliminary injunction issued in two patent infringement cases brought against the company by Illumina.

Judge William Orrick of the US District Court for the Northern District of California granted BGI the partial stay while the firm appeals the scope of the injunction. BGI filed an appeal with the US Court of Appeals for the Federal Circuit on July 15. The order will permit BGI's internal, noncommercial use of sequencers that do not use reagents that the court determined likely infringe Illumina's patents. Orrick also wrote that he will soon permit development activities relating to BGI's CoolMPS technologies that "stop short of any commercialization."

BGI said it would be able to use library preparation kits that had been enjoined by the original order, but which do not allegedly infringe Illumina's patents.

Pacific Biosciences this week appealed a jury verdict that invalidated four of its patents.

In a filing with the US District Court for the District of Delaware, PacBio notified the court that it was appealing "the Court's final judgment in this action, and from all other opinions, rulings, and orders adverse to PacBio" to the US Court of Appeals for the Federal Circuit.

PacBio had sued Oxford Nanopore Technologies in 2017, alleging infringement of four patents. In March, a jury found that Oxford Nanopore had infringed three of them, but also determined that all four patents were invalid.

Yourgene said this week that its Iona Nx NIPT workflow has been approved by Australia's Therapeutics Goods Association as a Class 3 medical device. The approval will allow Southern Cross Diagnostics, Yourgene's Australian distributor, to begin selling the test in that country.

Australia is the first major market outside of the UK or the European Union to have granted approval to the Iona Nx, following the CE-IVD approval it received on June 15, Yourgene said. The Iona Nx is an in vitro nucleic acid screening test that measures the likelihood that a pregnant woman is carrying a fetus with Trisomy 13, 18, or 21. It runs on the Illumina NextSeq 550Dx instrument.

Cancer diagnostics firm Celcuity this week reported that its net loss for the second quarter widened to $2.2 million, or $.21 per share, from a loss of $1.7 million, or $.17 per share, a year ago. The firm reported no Q2 revenues, nor did it report any revenues in the year-ago quarter.

Celcuity’s Q2 R&D costs rose 20 percent to $1.8 million from $1.5 million year over year, while its general and administrative costs rose 20 percent to $447,714 from $371,988.

The firm finished the quarter with $15.4 million in cash and cash equivalents.

Minneapolis-based Celcuity said it continued to develop additional CELsignia Pathway Activity tests in the second quarter. The CELsignia test for ovarian cancer identifies a subset of ovarian cancer patients whose tumors have abnormal c-Met signaling coincident with abnormal HER2 signaling. 

Todos Medical said this week it has reached a deal with an unnamed South Korean manufacturer to distribute its 10-minute, rapid point-of-care antigen test and 40-minute, rapid POC PCR-based test for SARS-CoV-2. The tests have been approved by regulators in South Korea, and Todos will assist the company to obtain Emergency Use Authorization from the US Food and Drug Administration, Todos said.

The rapid antigen test runs on a proprietary fluorescent immunoassay system and has demonstrated sensitivity of 86.49 percent and specificity of 97.87 percent. The rapid PCR tests runs on a proprietary POC PCR platform and has shown 100 percent sensitivity and specificity, according to Todos.

Co-Diagnostics this week said its second-quarter revenues skyrocketed to $24 million, up from $61,574 in Q2 2019. The molecular diagnostics company posted net income for Q2 of $12.6 million, or $.43 per share, compared to a loss of $1.3 million, or $.08 per share, in Q2 2019. Its Q2 R&D expenses rose 140 percent year over year to $750,249 from $312,590, and its sales, marketing, general, and administrative expenses climbed 136 percent year over year to $2.6 million from $1.1 million.

During Q2, CoSara Diagnostics, the firm's India joint venture, received authorization from the Central Drugs Standard Control Organization (CDSCO) in India to manufacture and sell COVID-19 tests. Co-Diagnostics noted it received US Food and Drug Administration Emergency Use Authorization for a COVID-19 test kit in April.

As of June 30, the Salt Lake City, Utah-based company had $18.6 million in cash and cash equivalents.

VolitionRx this week said that as of June 30, it had cash and cash equivalents of approximately $21.3 million. It further raised $13.8 million from a public offering in the second quarter.

Austin, Texas-based VolitionRx added that it purchased a manufacturing facility for €580,000 ($685,000) on the same science park as its R&D facility in Belgium, in preparation for the launch of its first products later this year.

Cameron Reynolds, the firm's president and CEO, said in a statement that during the second quarter, it focused on some important areas to mitigate the effects of lockdowns during the pandemic that allow it to continue moving toward its first commercial products, using its Nu.Q blood-based cancer detection platform. The company strengthened its balance sheet to ensure sufficient capital to work on many programs concurrently and launch products when possible during the pandemic. It also increased the flexibility of its supply chain and is moving toward producing key components in-house.

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.