NEW YORK — Accelerate Diagnostics late last week reported preliminary revenues for full-year 2024 of $11.7 million, down from $12.1 million in 2023. Consumables revenues were up 3 percent year over year, offset by lower capital sales of Pheno instruments compared to a year ago. The Tucson, Arizona-based IVD firm ended 2024 with $16.3 million in cash and cash equivalents.
MDxHealth this week reported Q4 2024 preliminary revenues of $24.7 million, up 28 percent from a year ago. Preliminary full-year 2024 revenues were also up 28 percent from a year ago to $90.0 million. In Q4, the firm billed 11,789 tissue-based units and 12,036 liquid-based units. For the full year, it billed 41,586 tissue-based units and 45,700 liquid-based units. For 2025, MDxHealth is issuing revenue guidance of $108 million to $110 million.
Mayo Clinic Laboratories announced last week that it will offer Lucence’s Liquid Hallmark NGS liquid biopsy assay for circulating tumor DNA and RNA across various cancers. The move is part of Lucence’s continuing effort to expand international access to its testing services.
Spear Bio said this week that its pTau 217 blood test has been granted breakthrough device designation by the US Food and Drug Administration. The test uses a wash-free workflow built on real-time PCR technology and is intended to be used as an aid in diagnosing Alzheimer’s disease.
PreludeDx said this week that the US Food and Drug Administration has granted the firm's DCISionRT test breakthrough device designation. The test is for evaluating a breast cancer patient's potential risk and benefit from radiation therapy. Specifically, it is used for patients with ductal carcinoma in situ breast cancer and combines tumor biology with clinicopathologic factors for personalized results. DCISionRT analyzes seven protein biomarkers and four clinical factors for a Decision Score that physicians can use to identify those patients who may benefit from radiation therapy and reduce over- and undertreatment, the Laguna Hills, California-based firm said.
Sysmex America said this week that it plans to build a new reagent manufacturing, distribution, and service center in Brazil. The firm has purchased 563,000 square feet of land in São José dos Pinhais and plans to begin construction on the new facility during the second quarter of 2025. The acquired property is four miles from Sysmex America's current leased manufacturing site, it said. Sysmex America is the regional affiliate of Kobe, Japan-based Sysmex.
Cerca Biotech and Shuwen Biotech said this week that MammaTyper, Cerca's breast cancer molecular subtyping assay, has been included in guidelines for breast cancer diagnosis and treatment by the Chinese Medical Association (CMA) and the China Anti-Cancer Association (CACA). MammaTyper uses real-time PCR to quantify mRNA levels for the breast cancer biomarkers ER, PgR, HER2, and Ki-67 in tumor biopsies or surgical samples to subtype the cancer according to St. Gallen guidelines. The kit has the CE mark, is approved by China's NMPA, and is distributed in China by Shuwen Biotech.
Swedish diagnostics firm Devyser this week released preliminary Q4 2024 results, with net sales of SEK 64.2 million ($5.8 million), up 42 percent from SEK 45.4 million in the year-ago period.
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.