NEW YORK – Mayo Clinic said this week it is investing $49 million to expand its laboratory in Rochester, Minnesota. The expansion will include new laboratory space for five clinical testing labs and Mayo Clinic Biopharma Diagnostics; an expanded and updated cafeteria for laboratory staff; and new laboratory support staff spaces at its Superior Drive Support Center. Construction has started and will continue through 2025. The laboratory expansion project follows recent announcements of investments at Mayo Clinic in Florida and across Mayo Clinic Health System.
Biocartis this week reported first quarter product revenues of €10.1 million ($11.0 million), up 17 percent from €8.6 million in Q1 2021. The Mechelen, Belgium-based molecular diagnostics firm booked revenues of €6.7 million for oncology testing, an increase of 42 percent year over year. However, year-over-year COVID-19 testing product revenues fell by half, and cartridge revenues for infectious disease testing overall fell to 10 percent of total product revenues, the firm said.
Meanwhile, the installed base of Biocartis' fully automated, real-time PCR-based Idylla instrument grew to 2,000 in the recently completed quarter. The average sales price per cartridge for oncology testing was €114 and for all products €101. The firm noted that during the quarter, it continued with the ramp-up of a fully automated manufacturing line and transferred the manufacturing of Idylla SARS-CoV-2 products to it. Biocartis had €37.3 million in cash at the end of Q1. The company anticipates full-year product revenues of €50 million to €55 million, an increase of 24 percent to 36 percent over full-year 2021.
Quanterix said this week that it has received breakthrough device designation from the US Food and Drug Administration for its neurofilament light chain (NfL) plasma test for multiple sclerosis. The test is intended as a prognostic aid in assessing the risk of disease activity in patients with relapsing-remitting MS.
Bluejay Diagnostics this week reported a first quarter net loss of $2.0 million, or $.10 per share, compared to a loss of $194,000, or $.06 per share, for the prior-year quarter.
For the quarter ended March 31, Bluejay's R&D expenses were $695,000, up more than twenty-eightfold year over year from $24,000, due to ongoing clinical studies and the scale-up of manufacturing for its Symphony IL-6 test for sepsis triage.
General and administrative expenses in Q1 were $1.3 million, up more than ninefold year over year from $140,000, mainly due to investments in infrastructure to support its growing operations. Of the total, $498,000 was expensed for company operations stemming from its initial public offering in November 2021. Meanwhile, Bluejay said its first quarter marketing and business development expenses were $54,000 compared to $69,000 in Q1 2021.
The Acton, Massachusetts-based company said that at the end of the quarter, it had cash and cash equivalents of $17.1 million, which is sufficient to fund operations past the date it anticipates getting US Food and Drug Administration clearance for its sepsis test. The company did not disclose the date.
Co-Diagnostics said this week that India's Central Drugs Standard Control Organization has cleared the Saraq Hepatitis C Viral Load kit from CoSara Diagnostics, Co-Diagnostics' joint venture for manufacturing and sales in India. The real-time PCR test for HCV leverages Co-Diagnostics' CoPrimer technology and is used as an aid to assess response to antiviral treatments for the virus.
The Access to Comprehensive Genomic Profiling Coalition (ACGP) said this week that it has added Blueprint Medicines to its coalition of companies advocating for payors to cover comprehensive genomic profiling (CGP) for advanced cancer patients. As part of its advocacy efforts, the coalition educates health insurers and other stakeholders across healthcare about CGP's clinical utility and economic value. ACGP considers any company that either offers CGP tests or offers products with CGP as eligible for potential coalition membership. Current members also include Labcorp, Exact Sciences, Invitae, Roche, Thermo Fisher Scientific, Strata Oncology, Tempus, Illumina, Foundation Medicine, NeoGenomics, and PGDx.
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