New Products

Laboratory Corporation of America has launched the Labcorp Plasma Detect and PGDx Elio Plasma Focus Dx tests. Plasma Detect is a blood-based whole-genome sequencing assay that detects circulating tumor DNA to identify the presence of molecular residual disease (MRD) in Stage III colon cancer patients. Labcorp launched the test for research purposes in early-stage colon cancer patients last year. It is now available through an Early Experience Program, after which Labcorp intends to expand its availability more broadly. The PGDx Elio Plasma Focus Dx test is a kitted pan-solid tumor liquid biopsy test intended to aid oncologists in selecting targeted cancer treatments. As an FDA-authorized test kit, the assay allows clinical laboratories and hospitals to retain control over patient specimens and data and returns results in four to five days.

Exact Sciences has launched Cologuard Plus, an updated version of its noninvasive, stool-based colorectal cancer screening (CRC) test. The assay is FDA-approved for average-risk patients aged 45 and older and is covered by Medicare. Exact's data, from a 20,000+ patient study called BLUE-C, indicate that Cologuard Plus detects 95 percent of colorectal cancers at 94 percent specificity in the US screening population. This translates to up to a 40 percent reduction in unnecessary colonoscopies compared to the original Cologuard assay. As Exact Sciences works to expand patient access to the new Cologuard Plus test, its original Cologuard test will remain available. 

Personalis has launched an early-access program for its NeXT Personal Dx, a tumor-informed, whole genome-based liquid biopsy test for detection of molecular residual disease and recurrence in cancer. The assay delivers sensitivity down to approximately 1 parts per million and allows patient-personalized ctDNA panels of up to 1,800 variants. The platform also employs a proprietary signal enhancement and noise suppression methodology. The early-access program is focused on lung cancer, breast cancer, and immunotherapy response monitoring.

NeoGenomics has made available two new cancer tests: Neo Comprehensive - Heme Cancers, a next-generation sequencing panel for comprehensive genomic profiling of hematologic malignancies, and the Early-stage Non-Small Cell Lung Cancer Panel, a therapy selection panel designed specifically for early-stage NSCLC patients. The firm said the NSCLC panel provides easy-to-interpret reports and a seven-day turnaround time.

Telo Genomics has launched the TeloViewSMM system to clinicians in the United States. Combining molecular biology and artificial intelligence, the diagnostic platform enables 6-factor quantitative analysis of 3D telomeres, which are the protective end caps of chromosomes. The company believes TeloView has the potential to characterize multiple cancers, identify their current level of genomic instability and predict their progression. The Company's initial clinical launch is focused on testin in cases of "Smoldering Multiple Myeloma," the precursor for Multiple Myeloma, a malignancy which develops in approximately 50 percent of individuals who start out with SMM. Currently the test is available for physicians to order under an observational study called SMART (Smoldering Multiple myeloma Assessment of Risk for Transformation). While the initial launch will be conducted within a single-site laboratory-developed test model, Telo aims to move eventually into commercial-scale test delivery in partnership with large reference labs where FISH and microscopy resources are available and scalable. 

Hedera Dx has launched a disseminated blood based cancer test kit, called the Hedera Profiling 2 ctDNA Test Panel, intended to help larger patient populations access precision cancer therapies. The firm said that its fully streamlined solution, a combination of laboratory reagents and interpretation software, allows hospitals to adopt liquid biopsy testing locally for their patients with minimal internal effort. The in-house test kits offer an alternative to various available send-out tests performed in centralized commercial laboratories. Assays cover over 80 percent of the ESMO Scale for Clincal Actionability of molecular Targets (ESCAT)  Level I genes. The wet lab component of the assay is coupled with the firm's Hedera Prime, a registered IVD medical device platform to rapidly interpret DNA sequencing results and quickly generate clinical reports

Mission Bio has launched a single-cell, multiomics, minimal residual disease (MRD) assay for acute myeloid leukemia (AML) on its Tapestri platform. The assay interrogates DNA and protein targets at single-cell resolution and characterizes genotypic and immunophenotypic changes over the course of disease. It identifies patients with recurrent AML and potentially offers clinicians actionable treatment targets. Targets include 40 genes for single-cell DNA sequencing based on current international AML MRD guidelines, such as European LeukemiaNet, and a 17-plex antibody-oligonucleotide conjugate panel curated for key biomarkers associated with AML MRD.

Roche has launched five research-use-only digital PCR assays for use with the firm's Digital LightCycler System. The Lightmix Digital Assays detect the BRAF V600E, EGFR T790M, EGFR Ex19del, KRAS G12D, and PIK3CA E545K mutations. The assays are being brought to market by TIB MolBiol, a subsidiary Roche acquired in 2021.

ChromaCode has launched a non-small-cell lung cancer (NSCLC) assay based on its High Definition PCR (HDPCR) technology for early-access customers. The assay panel detects actionable NSCLC variants in nine relevant genes using amplitude modulation and multi-spectral encoding. It requires low sample input, has reduced workflow complexity, cloud-based analysis, and can generate results in less than four hours.

Strata Oncology has launched a new test called Strata Select, which employs what the firm calls the Immunotherapy Response Score, a novel multivariate predictive biomarker algorithm for anti-PD-1/PD-L1 checkpoint inhibitor immunotherapy benefit described earlier this year in a publication in Communications Medicine.

The Immunotherapy Response Score integrates tumor mutational burden, PD-L1 and PD-1 expression, and tumor microenvironment components. It is generated from Strata's larger tumor profiling services, which are covered by Medicare contractor Palmetto under the MolDX program.