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In Brief This Week: Quest Diagnostics, Fluidigm, BD, and More

NEW YORK – The Nevada Department of Health and Human Services, Division of Public and Behavioral Health recently said that it has secured and launched a $10 million contract with Quest Diagnostics to provide COVID-19 testing for the state’s Department of Corrections and State Veteran’s Homes. Testing in Nevada’s correctional facilities account for 26 percent of the total number of COVID-19 tests in the state, and the contract with Quest is expected to reduce the burden on the Nevada State Public Health Laboratory, NDHHS said, adding the lab firm will provide its services until the end of 2020. The overall test turnaround time for NSPHL should also improve as a result of the contract, NDHHS said. The contract will cover about 100,000 molecular tests throughout Nevada.

Fluidigm this week announced that the Central Drugs Standard Control Organisation (CDSCO) in India has licensed importation and sale of its Advanta Dx SARS-CoV-2 RT-PCR Assay, one of the first saliva-based tests to be licensed for COVID-19 testing in India. The license granted to Premas Life Sciences, a Delhi-based life sciences distribution company, enables use of the test in laboratories approved by the Indian Council of Medical Research or a relevant state or central government. Fluidigm obtained Emergency Use Authorization from the US Food and Drug Administration for its Advanta Dx SARS-CoV-2 RT-PCR Assay in August.

Centogene said this week that it has expanded its 2019 partnership with PTC Therapeutics for aromatic L-amino acid carboxylase (AADC) deficiency testing. Centogene will now provide genetic testing and 3-OMD biomarker analytics to identify patients with AADC deficiency in new geographic areas, including countries in Europe, the Middle East, and Latin America. In addition, the firm will make its testing and biomarker analytics available for patients in the REVEAL CP study, a global screening study designed to determine the prevalence of AADC deficiency in patients with cerebral palsy of unknown cause. Financial or other terms of the expanded agreement were not disclosed. 

Ginkgo Bioworks said this week that it will receive a loan of up to $1.1 billion from the US International Development Finance Corporation (DFC) enabling the company to expand ongoing biosecurity efforts, including optimizing COVID-19 vaccine manufacturing, delivering widespread testing, and building infrastructure to help identify, prevent, and respond to future pandemics. Under the Defense Production Act, DFC, in coordination with the US Departments of Defense and Health and Human Services, supports domestic initiatives that will aid in the fight against COVID-19 in the US. Using the loan, Ginkgo said it will continue applying its platform to optimize manufacturing of critical raw materials required for production of nucleic acid vaccines against COVID-19. It will also continue programs such as Concentric by Ginkgo, a set of products focused on large-scale SARS-CoV-2 testing. 

RenalytixAI this week reported a net loss attributable to ordinary shareholders of $7.2 million, or $.10 per share, for the first quarter of fiscal 2021, compared to a net loss of $1.5 million, or $.03 per share, in Q1 2020.  

The New York-based kidney disease diagnostic company used approximately 69.8 million weighted-average shares outstanding to calculate its per-share loss in the recently completed quarter, compared to about 58 million weighted-average shares outstanding in the same period of 2020.

For the three months ended Sept. 30, the company's R&D expenses rose 42 percent year over year to $1.7 million from $1.2 million, while its general and administrative expenses rose almost fivefold to $4.1 million from $837,000.

Among recent business highlights, the firm launched its KidneyIntelX blood-based assay for acute and chronic kidney disease detection within the Mount Sinai Health System.

The firm also announced a collaboration with AstraZeneca to develop and launch precision medicine strategies for cardiovascular, renal, and metabolic diseases, and said it completed the spin-out of Verici Dx, previously FractalDx.

In June, the company announced a dual listing on the Nasdaq.

At the end of Q1, it had cash, cash equivalents, and short-term investments of $82.3 million.

Further, Kantaro Biosciences, a joint venture of Mount Sinai Health System and RenalytixAI, announced Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for the COVID-SeroKlir semi-quantitative SARS-CoV-2 IgG antibody test kit.

Toronto-based molecular diagnostic company StageZero Life Sciences this week reported revenues of $1.5 million for the third quarter ended Sept. 30.

During the quarter, the company announced it obtained preferred lab status from the government of Barbados for COVID-19 testing aimed at allowing air travel to commence. StageZero added that in Q3, it also expanded its laboratory footprint and automation, introduced a respiratory panel, and introduced at-home collection for PCR testing using saliva samples.

Its partner, Ichor Blood Services, announced an expansion of COVID-19 testing involving an agreement with the state of Hawaii and the initiation of testing for travel to China.     

At the end of Q3, the firm had $1.8 million in cash.

Becton Dickinson said this week that its board has declared a quarterly dividend of $.83 per share of its common stock, an increase of 5.1 percent from the prior quarter. The dividend will be payable on Dec. 31, 2020 to shareholders of record on Dec. 10. 

Co-Diagnostics said this week that India's Central Drugs Standard Control Organization has cleared the company's joint venture, CoSara Diagnostics, to manufacture and sell the Saragene COVID-19 2-gene multiplex RT-PCR test kit.

CoSara Dx is a JV between Co-Diagnostics and Synbiotics Limited established in 2017 to manufacture and sell assays in India.

The Saragene test kit is for the qualitative detection of the SARS-CoV-2 virus and uses Co-Diagnostics' CoPrimer technology. It is based on a test originally designed by the Salt Lake City-based firm called the Logix Smart SARS-CoV-2 multiplex test. Both tests target two gene biomarkers of the SARS-CoV-2 genome, the RdRp and E genes, to identify the presence of the virus.

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.