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Bio-Rad Laboratories Exact Diagnostics Group B Strep Run Controls

Bio-Rad Laboratories has launched quality controls for use with Group B Streptococcus molecular assays. Called Exact Diagnostics GBS Positive and Negative Run Controls, they complement the previously launched Exact Diagnostics GBS Verification & Validation Panel. The positive control contains whole, intact, heat-inactivated GBS bacteria at a challenging concentration, to simulate a low positive clinical specimen, while the negative control contains human cells to mimic adequate specimen sampling. Both controls are formulated in LIM broth matrix, internally tested using Bio-Rad Droplet Digital PCR, and manufactured independently from the Exact Diagnostics GBS Verification & Validation Panel.

Qiagen QiaStat-Dx Gastrointestinal Panel 2

Qiagen has launched the QiaStat-Dx Gastrointestinal Panel 2 for use in clinical settings following its recent clearance by the US Food and Drug Administration. The real-time PCR syndromic panel runs on the cartridge-based, sample-to-answer QiaStat-Dx Analyzer 1.0, identifies up to 16 common gastrointestinal pathogens, generates results in about one hour, and allows access to Ct values and amplification curves.

Laboratory Corporation of America: OmniSeq Insight for ctDNA

Laboratory Corporation of America has launched its OmniSeq Insight circulating tumor DNA assay as part of its comprehensive genomic profiling portfolio. The new assay complements the existing OmniSeq Insight product by evaluating the same biomarkers, enabling delivery of integrated and uniform genomic variants, tumor mutational burden and microsatellite instability detection from blood and tissue specimens to support exploratory and longitudinal biopharmaceutical studies.

Indica Labs Halo, Halo AI, Halo Link

Digital pathology firm Indica Labs has released new versions of its Halo, Halo AI, and Halo Link software. The company said that the 4.0 versions of the firm's software provide improved ease of use and performance, optimized workflows, and the ability to expand the use of artificial intelligence-based image analysis in digital pathology. The firm said that Halo 4.0 customers can use pretrained deep learning-based networks for automated nuclear and membrane segmentation in brightfield and fluorescence while Halo AI 4.0 includes a new AI-based annotation tool for objects ranging in size from a nucleus to a kidney cross section. The Halo Link 4.0 software, which is used for collaborative pathology, also has features including improved performance from an updated image server, the ability to view interactive markups, and the ability to view, sort, and filter slide metadata from Halo Link in Halo 4.0.

Tempus/Personalis xM (NeXT Personal Dx) Test

Tempus and Personalis said this week that Tempus has officially launched the xM (NeXT Personal Dx) Test, developed by Personalis. The new ultra-sensitive, tumor-informed minimal residual disease (MRD) and monitoring test is based on whole-genome sequencing and can detect small traces of circulating tumor DNA (ctDNA) in the blood of patients with early non-small cell lung cancer (NSCLC) and breast cancer following curative intent treatment. The test can also be used for immunotherapy monitoring in late-stage cancer across all solid tumors. The assay identifies up to 1,800 somatic variants unique to a patient's tumor, supporting physicians in making informed, individualized patient-management decisions.

Tempus and Personalis are co-commercializing the assay under an agreement announced last fall. The assay also supplements Tempus' own xM MRD assay, which it launched earlier this year to detect circulating tumor DNA in the blood of patients with early-stage colorectal cancer after surgery.

Qlucore Insights

Swedish company Qlucore has released a new version of Qlucore Insights, a bioinformatics model to classify primary lung tumor samples and metastatic lung cancer lesions that was developed in collaboration with Heidelberg University Hospital in Germany. The new model assigns a sample to one of 18 subgroups. It is based on RNA data from more than 300 FFPE samples and was developed using AI-based machine learning techniques.

Foundation Medicine FoundationOne RNA

Roche subsidiary Foundation Medicine has launched its FoundationOne RNA test for clinical use in the US. The tissue-based RNA sequencing test detects cancer-related fusions across 318 genes and enables reporting of fusions in all solid tumors. Foundation noted that the test may be valuable for detecting fusions in certain cancers, including non-small cell lung cancer, pancreatic cancer, cholangiocarcinoma, sarcoma, thyroid cancer, and bladder cancer. The company originally made the test available in September 2023 for research and investigational use. FoundationOne RNA can now be added to FoundationOne CDx orders for even greater confidence in fusion detection, the company noted.

Bosch Healthcare Solutions Vivalytic Candida Auris Assay

Bosch Healthcare Solutions has launched a PCR test for detecting Candida auris on the Vivalytic platform. The system can provide fully automated detection of the fungus in less than one hour at the point of care, and can be used for diagnosis or screening. The Vivalytic C. auris test is now available from distribution partners, including Randox Laboratories and R-Biopharm, and Bosch Healthcare Solutions is in the process of obtaining CE certification.

Laboratory Corporation of America: Preeclampsia Screening Test

Laboratory Corporation of America said this week it has launched its first trimester preeclampsia screening test, a blood-based test to be performed between 11 and 14 weeks gestation to determine an individual's risk of developing preeclampsia before 34 weeks of pregnancy. The test measures the protein biomarkers placental growth factor and pregnancy-associated plasma protein-A along with the biophysical markers mean arterial pressure and uterine artery pulsatility index and, according to Labcorp, has sensitivity of up to 90 percent.

Thermo Fisher Scientific CXCL10 Testing Service

Thermo Fisher Scientific has launched the CXCL10 testing service. Thermo Fisher Scientific One Lambda Laboratories, the company’s CLIA facility, will offer the urine-based, non-invasive assay that can detect the CXCL10 chemokine. The turnaround time for the test, from urine sample collection to results can be as little as 24 hours, the company said.