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In Brief This Week: Quidel, Ortho Clinical Diagnostics, Hologic, Guardant Health, and More

NEW YORK – Quidel announced this week that it will open a new manufacturing facility for its QuickVue line in Carlsbad, California. The 128,000-square-foot facility will begin operations in the second half of 2021 and will be the company’s highest-volume production plant, expected to produce 600 million QuickVue SARS rapid antigen tests per year for the detection and diagnosis of COVID-19 infections. Quidel said it will install multiple manufacturing lines at the Carlsbad facility and will hire approximately 400 new employees to scale its operations from 50 million QuickVue tests per year to 50 million tests per month at full capacity, including non-COVID-19 diagnostic assays currently commercially available or under development. The firm also said it is currently hiring engineers, chemists, and technicians, as well as for positions in manufacturing, purchasing, sourcing, and support services.


Ortho Clinical Diagnostics this week said it closed the sale of an additional 11.4 million ordinary shares following an over-allotment option granted to the underwriters in its initial public offering. The additional shares were sold at $17 per share, less underwriting discounts and commissions, and generated total additional gross proceeds of approximately $193.8 million.

Ortho intends to use the net proceeds from the offering, including the exercise of the over-allotment option, to redeem $160 million in aggregate principal amount of 7.375 percent senior notes due in 2025 and $270 million in aggregate principal amount of 7.250 percent senior notes due in 2028; repay borrowings under its dollar term loan facility; and for working capital and general corporate purposes, which may include further repayment of indebtedness, the firm said.


Hologic this week announced a multi-year strategic collaboration to integrate Google Cloud's machine learning technologies with Hologic's Genius Digital Diagnostics System.

The Genius Digital Diagnostics digital cytology platform combines artificial intelligence with advanced digital imaging to help identify pre-cancerous lesions and cancer cells in women. Hologic said Google Cloud enhances its platform's deep learning component. With Google Cloud, the Genius Digital Diagnostics System is expected to derive more actionable insights from cytology slides for cytotechnologists and pathologists, Hologic said.

Financial terms of the collaboration were not disclosed.


Guardant Health’s Asia, Middle East & Africa division this week submitted its application to Japan’s Ministry of Health, Labour and Welfare for regulatory approval of the Guardant360 CDx assay for comprehensive genomic profiling in patients with advanced solid tumors and as an unspecified companion diagnostic.

Guardant360 CDx, a blood-based liquid biopsy test, analyzes circulating tumor DNA and identifies genetic alterations that may inform treatment decisions. Last August, the US Food and Drug Administration approved the test for comprehensive genomic profiling across solid tumors and as a companion diagnostic to identify non-small cell lung cancer patients with EGFR alterations who may benefit from treatment with osimertinib (AstraZeneca’s Tagrisso).


The Access to Comprehensive Genomic Profiling Coalition this week appointed NeoGenomics and Tempus to its coalition of diagnostic firms and laboratory service providers to advocate for appropriate broad US health insurance coverage of comprehensive genomic profiling for patients living with advanced cancer.


Revelation Biosciences said this week it has closed a private placement that raised $4.4 million in gross proceeds. National Securities, a wholly owned subsidiary of National Holdings, was the exclusive placement agent on the Series A-1 preferred stock financing. Menlo Park, California-based Revelation sold 684,444 shares of the preferred stock at a purchase price of $6.36 per share. It said that it has raised $14.5 million in total gross proceeds to date. The company plans to use the proceeds from the most recent financing for working capital and the development of its REVDx-501, a diagnostic test for upper respiratory viral infections including COVID-19, and REVTx-99, a therapy for respiratory viral infections. The financing will also go toward general administrative operations.


The American Association of Clinical Chemistry announced this week that it has sold its Lab Tests Online resource on laboratory testing to digital health company OneCare Media. Lab Tests Online helps people better understand clinical laboratory tests, the AACC said, and added that the agreement with OneCare Media will allow the site to expand its scope and reach more consumers. Under the agreement, OneCare will have an expert advisory board for the site, and one-third of that board will be members of AACC. Financial terms of the deal were not disclosed. OneCare Media’s other sites include Testing.com, OnlineDoctor.com, and OnlineTherapy.com.


Bio-Techne said this week that it will pay a dividend of $.32 per share for the quarter ended Dec. 31, 2020, payable on Feb. 26 to common shareholders of record on Feb. 12.


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.