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In Brief This Week: Natera, BioMérieux, Castle Biosciences, PathoFinder, EWC

NEW YORK – Natera said last week that the US Patent Office has upheld all claims of one of its patents that were under scrutiny in an inter partes review initiated by Illumina in 2019.

The patent, US Patent No. 8,682,592, "System and method for cleaning noisy genetic data from target individuals using genetic data from genetically related individuals," was also the subject of a patent infringement lawsuit between Natera and Illumina that was settled in May.

Natera said the patent office deemed all challenged claims of the '592 patent as patentable. It said the patent describes core DNA quantitation methods and methods using genotyping for analyzing small amounts of DNA and is useful for various applications, including noninvasive prenatal testing, circulating tumor DNA molecular residual disease testing, and donor-derived cell-free DNA testing in organ transplant recipients.

BioMérieux and its subsidiary Invisible Sentinel received the first-ever COVID-19-related certificate of validation for the Veripro SARS-CoV-2 Environmental Assay this week from the AOAC International emergency response validation program. The assay uses one-step RT-PCR for qualitative detection of SARS-CoV-2 on stainless steel, concrete, plastic, ceramic, and other surfaces without the need for supplies and reagents typically used in clinical testing.

Scottsdale, Arizona-based PathogenDx also received an ERV certificate this week from AOAC for its EnviroX-Rv test on its multiplex microarray platform. The kit is intended for commercial SARS-CoV-2 testing on concrete, plastic, and other non-porous high-use surfaces.

Castle Biosciences said this week that it has prepaid in full an outstanding term loan facility in an effort to improve its balance sheet. The Texas-based cancer diagnostics firm paid the lenders, Oxford Finance and Silicon Valley Bank, approximately $21.6 million including pay-off amounts for principal, interest, fees, reimbursement of expenses, and other items.

Dutch diagnostics firms PathoFinder and EWC Diagnostics announced they are collaborating to expand COVID-19 testing capacity in the Netherlandsproviding the Dutch government with sets of sample collection materials and test kits. Specifically, the firms are providing EWC’s nasal and throat swabs and viral transport medium along with PathoFinder’s RealAccurate Quadruplex SARS-CoV-2 PCR kit, which has the CE-IVD mark. EWC is distributing the products throughout the Netherlands. 

The announcement comes less than a week after EWC teamed with MolGen and Hamilton to ramp up SARS-CoV-2 testing capacity in the Netherlands. As part of that alliance, EWC is providing the PathoFinder PCR tests and PCR instrumentation from Bio-Rad Laboratories. 

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.