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In Brief This Week: BGI, Novacyt, Promega, and More

NEW YORK – BGI and Abu Dhabi-based technology firm Group 42 (G42) said this week that they have launched a new high-throughput laboratory for COVID-19 testing in the United Arab Emirates. The lab, located in Masdar City, Abu Dhabi, has the capacity to conduct tens of thousands of RT-PCR tests per day and will use BGI's RT-PCR diagnostic kit for the detection of SARS-CoV-2. It emerged from an ongoing partnership between G42 and BGI around a population genomics project that was announced last December.

Novacyt said this week that its manufacturing partner for its COVID-19 test is BioType Diagnostic, based in Dresden, Germany. The test was developed by PrimerdesignNovacyt's molecular diagnostics division in the UK, and has received CE marking and US Food and Drug Administration Emergency Use AuthorizationBioType has already delivered the first batches of product to Primerdesign for final test assembly and will increase its output under the contract.

Promega said this week that its GoTaq Probe 1-Step RT-qPCR system has been approved as a master mix option for the US Centers for Disease Control and Prevention'coronavirus test, which received Emergency Use Authorization from the US Food and Drug Administration in February. The FDA granted approval of an amendment to the test on March 30 to acknowledge that Promega’s master mix is an approved amplification reagent for labs using the CDC assay, Promega said.

OpGen announced this week it has closed its acquisition of CuretisCuretis is now a wholly owned business of OpGen, with former CEO of Curetis Oliver Schacht now acting as president and CEO of OpGen. William Rhodes III, former chairman of Curetis’ board of directors, is now serving as chairman of OpGen’s board of directors, with former OpGen CEO Evan Jones acting as a member of the board.

Danaher announced this week that it has completed its $21.4 billion acquisition of General Electric’s biopharma business. The business will now be called Cytiva and will operate as a standalone company in Danaher’s life sciences segment.

In a filing with the US Securities and Exchange Commission this week, Castle Biosciences said it has received notice from the Centers for Medicare and Medicaid Services that the Medicare payment rate for its DecisionDx-Melanoma test under Medicares Clinical Laboratory Fee Schedule is $7,193 for dates of service beginning on or after April 1, 2020 through Dec. 31, 2021.

Luminarie Canada and its development partner 1drop announced this week that Health Canada has issued an authorization for importation and sale of 1drop’s novel RT-qPCR 1copy COVID-19 qPCR Multi Kit. Luminarie is the exclusive distributor of this PCR kit in Canada. 

The 1copy kit allows for the qualitative detection of SARS-CoV-2 by amplification of two viral target genesRdRp and the E gene, with real-time qPCR via RNA extracted from clinical specimens from nasopharyngeal swabs or oropharyngeal swabs of suspected respiratory infectious disease patients, Luminaire saidRdRp is the SARS-CoV-2 specific detection target, and the E gene is detection target specific to the beta coronavirus. 

The kit has an extremely high sensitivity with a limit of detection of 200 copies per mL, and a turnaround time of less than 2 hours, the company said. The kit has been approved in several countries, including Germany, South Korea, Sri Lanka, Luxemburg, Paraguay, Georgia, Bulgaria, and Canada, and has been submitted for approval in the US.

Bioké, a business unit of Cell Signaling Technology Europe, announced this week that it has signed a distribution agreement with biotech company Abc Biopply to distribute Abc’s 3D CoSeedis cell culture technology in the Netherlands, Belgium, and Luxembourg, effective immediately. The scaffold-free 3D cell co-culture system allows for the formation of spheroidal and non-spheroidal cell aggregates in a highly-reproducible manner, the company said.

Todos Medical said this week that it has expanded a previously announced distribution agreement with Gibraltar Brothers & Associates, a US subsidiary of China-based Shanghai Liangrun Biomedicine Technology. The expanded agreement includes PCR test kits in addition to an IgM and IgG immunochromatography antibody test called Colloidal Gold. 

Gibraltar had been granted exclusive rights for test distribution in the US and Israel. Geographic locations under the expanded agreement also include Singapore, Malaysia, Indonesia, Thailand, Myanmar, Vietnam, Philippines, Cambodia, Laos, Hong Kong, Japan, South Korea, Taiwan, India, the UK, Sweden, Italy, India, the Gulf states, Dubai, and the United Arab Emirates.  

Todos Medical Singapore CEO Joseph Wee will be responsible for commercialization in Asia.

Regeneron Pharmaceuticals said this week that it is assisting New York State's COVID-19 testing efforts by donating viral transport media (VTM), a liquid used to preserve patient samples until they can be tested, which is an important component of COVID-19 test kits. As of earlier this week, the company had formulated more than 100,000 units of VTM and said it was committed to making more than 500,000 in total.

Co-Diagnostics this week reported that its full-year 2019 revenues grew more than 400 percent year over year to $214,974 from $39,911 in 2018. The firm said that the revenue growth was due to an expanded licensing deal with LGC and the launch of its vector control vertical in mid-2019. 

The company had a net loss of $6.2 million, or $.36 per share, in 2019 compared to a net loss of $6.3 million, or $.50 per share, in 2018. Co-Diagnostics' R&D expenses were relatively flat year over year at $1.4 million, while its SG&A costs were trimmed 2 percent to $4.6 million from $4.7 million. It had $893,138 in cash and cash equivalents as of Dec. 31, 2019.  

Subsequent to the end of 2019, Co-Diagnostics received CE marking for its coronavirus test. It also closed on an offering of its stock that raised about $5 million and entered into separate deals with institutional investors to raise $10.2 million and $4.2 million.

The US Food and Drug Administration this week granted Abbotts request to update the instructions for use (IFU) for the company’s RealTime SARS-CoV-2 assay to add the use of Abbott’s Multi-Collect Specimen Collection Kit and make minor edits to the IFU. The agency also added "nasal swabs, self-collected at a health care location or collected by a healthcare worker, nasopharyngeal and oropharyngeal swabs collected by a healthcare worker" as specimens in the intended use.

Predictive Oncology reported this week that its revenues for FY2019 were $1.4 million, flat year over year compared to $1.4 million in 2018. Revenues in both years were primarily driven by sales of the company's StreamWay fluid disposal systems, of which it sold 43 units and 41 units, respectively, in 2019 and 2018. 

The company’s net loss was $19.7 million in 2019 compared to $10.1 million in 2018, owing in part to expenses from its 2018 merger with Helomics, goodwill impairment, and other extraneous expenses related to the transaction.

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.