NEW YORK – Novacyt said on Monday that it has partnered with German company BioType Diagnostic to manufacture its COVID-19 test. Under the agreement, BioType, based in Dresden, has delivered the first batches of products for final assembly to Primerdesign, Novacyt's UK-based molecular diagnostics division.
In addition, Novacyt said that the test received approval from Argentina's National Administration of Drugs, Foods, and Medical Devices (ANMAT) on March 27 and emergency use approval in India on March 26. It already had obtained Emergency Use Authorization from the US Food and Drug Administration on March 23 and the CE mark in February.
Co-Diagnostics this week said that its full-year 2019 revenues grew more than 400 percent year over year to $214,974 compared to $39,911 in 2018. In a statement, the Salt Lake City-based firm noted an expanded licensing deal with London, UK-based LGC and the launch of its vector control vertical in mid-2019 for the revenue growth.
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. 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. 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 separate deals with institutional investors to raise $10.2 million and $4.2 million.
The US Food and Drug Administration granted Abbott’s 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 healthcare location or collected by a healthcare worker, [and] nasopharyngeal and oropharyngeal swabs collected by a healthcare worker” as specimens in the intended use.
Danaher announced this week that it has completed its $21.4 billion acquisition of General Electric’s biopharma business. The business will be called Cytiva under Danaher, and will be a standalone operating company in Danaher’s Life Sciences segment.
Shield Diagnostics has gone out of business and is liquidating its assets. Last month, the San Jose, California-based antibiotic resistance testing firm entered an assignment for the benefit of its creditors and made a general assignment of its assets to Shield, a California limited liability company created to liquidate the assets of Shield Dx. The two firms have no corporate affiliation with each other, Shield Dx said in court papers.
Promega’s GoTaq Probe 1-Step RT-qPCR system has been approved as a master mix option for the US Centers for Disease Control and Prevention's 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 include "acknowledgement that [the] Promega master mix is an approved amplification reagent for laboratories using CDC's assay," Promega said in a statement this week.
Todos Medical said this week 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 granted exclusive rights for test distribution in the US and Israel. However, 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 United Kingdom, Sweden, Italy, India, Gulf states, Dubai, and the United Arab Emirates. Joseph Wee, CEO of Todos Medical Singapore, will be responsible for commercialization in Asia.
OpGen announced this week it has closed its acquisition of Curetis. Curetis 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 as a member of the board.
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