Week in Review: QuidelOrtho and Exact Sciences Announce Third Quarter Revenues; Roche launches laboratory products; GPA Notes 2022

Dear LabPulse Reader:

For its first full quarter following a business combination, QuidelOrtho, after market close Wednesday, reported a 54% year-over-year increase in revenue.

The increase is largely due to the closing of Quidel’s merger with Ortho Clinical Diagnostics in May.

Total combined incremental revenue of $783.8 million was actually down 24% year over year. Although Molecular Diagnostics revenue was down 72% in the quarter, it was only down 1% when COVID-related revenue activities are excluded. COVID-related revenue contributed $171 million to QuidelOrtho’s revenue in the quarter.

Exact Sciences, a company less reliant on infectious disease testing, reported third-quarter revenue of $523.1 million on Thursday evening, up 15% from $456.4 million. of the third quarter of 2021.

Excluding COVID-19 revenue for the current quarters and prior year, revenue was up 20%, the company said.

COVID-19 testing revenue in the third quarter was $10.9 million, down 64% year-over-year.

It’s been a busy week for Roche. The company announced Friday at the HLTH 2022 meeting in Las Vegas the introduction of the Navify brand to its digital health portfolio. The Navify brand includes more than 30 digital solutions for laboratories, hospitals and patients around the world.

Earlier in the week, the company announced plans to launch its Cobas 5800 system in the United States at the Association for Molecular Pathology (AMP) 2022 annual meeting this week in Phoenix. The compact, fully automated molecular laboratory instrument is based on Roche’s Cobas 6800 and 8800 high-volume automated systems and offers PCR assays for the diagnosis of infectious diseases.

Biocartis presented nine study abstracts at AMP 2022. One study evaluated blood-compatible Immunexpress SeptiCyte Rapid ethylenediamine tetraacetic acid (EDTA) cartridges on the Biocartis Idylla platform.

Roland Carlson, the CEO of Immunexpress, spoke to us on the sidelines of the AMP, telling us that the company is officially launching SeptiCyte Rapid at the event. He believes his operation, directly from blood and without requiring a positive blood culture, has the potential to significantly speed up the diagnosis of sepsis, allowing for faster and more accurate treatment.

On Thursday at AMP, Gabriel Bien-Willner, MolDX Program Medical Director at Palmetto GBA, a Medicare Administrative Contractor (MAC), presented insights on demystifying the MolDx technical assessment process.

MolDX seeks to understand the molecular testing landscape in order to implement payer controls, coverage and define policy for MAC Affiliates, which currently covers 28 states.

In making decisions about molecular diagnostic test coverage, MolDX administrators increasingly consider clinical utility – the ability of a test to prevent adverse health effects – as part of its general evaluation criteria.

Manoj Gandhi, senior medical director for infectious diseases at Thermo Fisher Scientific who attended the presentation, told LabPulse he thinks the requirements are likely to be an additional burden on those working on lab-developed tests that offer a wide genetic coverage. Proving clinical utility takes a lot of time and investment, he noted. This can discourage the development of life-saving tools for specific groups of patients and medical conditions.

Keep an eye out next week for more details on LabPulse from MolDx presenting and others at AMP 2022.

Best wishes,

Leo O’Connor

Chief Editor

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