NEW YORK — Leica Biosystems said this week that it will not enforce its digital pathology Digital Imaging and Communications in Medicine patent portfolio and allow companies to use the standard without having to license the patent. By doing so, the Danaher subsidiary “hopes to foster greater innovation and cooperation within the industry to shape a brighter future for digital pathology," it said in a statement. Leica noted that the use of DICOM in digital pathology is growing, resulting in better interoperability by standardizing the storage, transmission, and sharing of whole-slide images and associated data.
Cancer assay developer Delfi Diagnostics said this week that its Delfi-Tumor Fraction (Delfi-TF) Monitoring cell-free DNA assay has been selected by Incendia Therapeutics to evaluate treatment response and disease progression in patients enrolled in a Phase I clinical trial. The trial is designed to evaluate the safety and tolerability of Incendia's PRTH-101 alone or in combination with pembrolizumab in adults with advanced or metastatic solid tumors.
Devyser Diagnostics reported this week that its third quarter net sales rose 4 percent to SEK 48.7 million ($4.5 million) from SEK 46.7 million one year earlier, and it said that net sales were up 7 percent with adjustments for exchange rate fluctuations. The Swedish diagnostics developer posted an after-tax loss of SEK 23.2 million, or SEK 1.41 per share, for the quarter ended in September compared to a loss of SEK 6 million, or SEK .37 per share, in the quarter one year ago.
Australian molecular diagnostics company Genetic Signatures reported A$4.7 million (US$3.1 million) in revenues for the first quarter of its fiscal year 2025 this week, an almost fourfold increase over the prior-year period. Sales were boosted by the firm's EasyScreen respiratory pathogen detection kit after the Therapeutic Goods Administration (TGA) authorized the updated version in Australia. During the quarter, the company focused on preparing the US commercial launch of its EasyScreen gastrointestinal parasite detection kit, which received US Food and Drug Administration clearance in June. The company did not report any net income or loss. As of Sept. 30, Genetic Signatures held A$41.3 million in cash, including proceeds from a A$30 million capital raise that was completed in July.
Canadian biotech firm Telo Genomics this week said it has amended its deal with the Mayo Clinic, extending the original 2019 agreement to include Mayo’s participation in the company’s Physician Experience Program using Telo’s TeloView SMM prognostic test for smoldering multiple myeloma patients. SMM is a precursor to active multiple myeloma. Patient samples will also be used to validate TeloView NDMM, a test in development for newly diagnosed multiple myeloma patients. The validation is being carried out in anticipation of the test being offered as a laboratory-developed test by Telo. TeloView NDMM would enable the identification of patients who will relapse on first-line therapy within a year or confirm that patients are stable in remission on the treatment at the time of testing, Telo said. It added that it has completed the endpoints for the validation of TeloView SMM, and the test is now offered as an LDT.
Swedish blood collection technology firm Capitainer said this week that it has registered its self-sampling kits with the Swedish Medical Products Agency, in accordance with the Medical Device Regulation/In Vitro Diagnostic Regulation in the EU. The kits are now compliant with the IVDR and are CE marked as Class A devices, which are products deemed as being the lowest risk to the public. The kits are now available within the EU and the UK.
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.