MiR Scientific said it has launched its prostate cancer test MiR Sentinel in the United States, Puerto Rico and select international markets. The urine-based test analyzes small non-coding RNA using a proprietary biostatistical algorithm to assess the risk of aggressive prostate cancer and aid in the clinical management of men 45 years of age or older.
The current test is a refined and clinically validated version based on the firm's comprehensive miR Sentinel PCC4 assay, which received FDA Breakthrough Device Designation in the third quarter of 2020, as well as its original three-test model described in a proof-of-concept publication the same year.
BillionToOne has launched its first oncology liquid biopsy products, Northstar Select and Northstar Response. The assays are currently available for research use with select academic cancer centers, but the firm intends a full commercial launch early next year.
Northstar Select is a comprehensive pan-cancer somatic mutation profiling panel and Northstar Response is a methylation-based, tissue-agnostic treatment response monitoring assay. Both employ BillionToOne’s proprietary molecular counting technology, called Quantitative Counting Templates, which the firm said enables a low limit of detection for identification of actionable alterations.
Guardant Health has launched Shield, the company's first blood-based test for the detection of early-stage colorectal cancer. The test is performed on a simple blood draw sample and is intended for adults age 45 and older who are not up to date with recommended screening guidelines, show no symptoms, and are at average risk for CRC. In a 300-patient validation, the test showed 91 percent sensitivity, including 90 percent sensitivity for Stage I, 97 percent for Stage II, and 86 percent for Stage III cancers, and 20 percent sensitivity for advanced adenomas, with 92 percent specificity.
OncoDNA has launched the OncoDeep kit, a disseminated version of its in-house OncoDeep cancer sequencing assay. According to the company, the kit offers a complete workflow solution incorporating Twist Bioscience's enrichment and library preparation solutions. The panel covers over 600 cancer biomarkers, and will be coupled with OncoDNA's data analysis and clinical interpretation tools. The test panel is optimized for the reliable analysis of somatic variants and translocations while also facilitating the measurement of complex genomic signatures such as homologous recombination deficiency, tumor mutational burden, microsatellite instability, and loss of heterozygosity. The kit is currently available for early access, with a full launch planned by the end of Q2 2022.
GenDx has added a new assay to its product portfolio, NGSgo Oncodentify. The test, developed in collaboration with the University Medical Center of Utrecht, identifies mutations in JAK2, CALR and MPL to determine prognosis and guide treatment decisions for patients with myeloproliferative neoplasms. Intended for use on Illumina sequencing platforms, the kit is the first of what the company said is a series of assays to detect somatic mutations related to hematological malignancies.
The assay is currently for research use only but GenDx said it is in the process of validating it as a clinical in vitro diagnostic.
Biodesix has launched GeneStrat NGS, a 52-gene blood-based tumor profiling test intended to help physicians treating advanced-stage lung cancer patients identify targeted therapy mutations, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others. Sequencing results are further interrogated using PierianDx's variant interpretation knowledge database. Physicians receive a streamlined report with a 72-hour turnaround time.
GeneStrat NGS is also a component of a broader test package that Biodesix also recently launched, the IQLung Treatment Guidance Testing Strategy, which includes blood-based proteomic and genomic testing workflows. The company said it plans to add tests to the IQLung portfolio in the future.
Personalis has launched NeXT Personal, a tumor-informed liquid biopsy assay designed to detect and quantify molecular residual disease and recurrence in patients previously diagnosed with cancer. The assay boasts sensitivity down to the 1 part-per-million range and uses whole-genome sequencing of a patient's tumor to identify up to 1,800 somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient.
With broader content than other available assays, these panels can also be used to detect clinically relevant alterations with a potential impact on therapeutic decision-making. Personalis said NeXT Personal is currently for research use only and that it plans to release it as a clinical test next year.
Thermo Fisher Scientific has released the Ion Torrent Oncomine Myeloid Assay GX v2, a next-generation sequencing assay that allows researchers to gather comprehensive mutational results from myeloid samples in a single day using the company's Ion Torrent Genexus System.
The Oncomine Myeloid Assay GX v2 offers a comprehensive panel to profile key biomarkers for all major myeloid disorders. It's optimized to detect a wide range of variants, including challenging-to-sequence targets such as FLT3-ITD, CALR, and CEBPA, Thermo Fisher said. The updates for this version of the assay include additional DNA and RNA targets, improved sequencing of key GC-rich regions, and the ability to run the RNA and DNA panels separately.
The assay also features an automated workflow, enabling samples to be processed from specimen to report with only 20 minutes of hands-on time for technicians and minimal user intervention; an expanded panel with simultaneous profiling of 45 genes and 30 fusion drivers covering more than 700 unique fusions; full specimen coverage, including whole blood, peripheral blood lymphocytes, and bone marrow; and integrated reporting, with annotated variant reports and the latest relevant evidence from public data sources.
Laboratory Corporation of America has launched Qiagen's Therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer who are eligible for treatment with sotorasib (Amgen's Lumakras). The drug and the test were approved by the US Food and Drug Administration in late May. The assay uses a liquid biopsy specimen to identify patients with a specific mutation in the KRAS gene called KRAS G12C and who have received at least one prior systemic therapy. Citing statistics from the American Cancer Society, Labcorp said between 10 and 12 percent of the 228,000 people diagnosed with lung cancer carry the mutation. In 2019, Qiagen joined Labcorp's Day-One lab readiness program to expedite patient access to Qiagen's CDx products following regulatory approval of the tests and associated drugs.
Natera's Signatera assay, which has been utilized to identify molecular residual disease earlier than standard imaging in clinical studies of non-small cell lung, bladder, breast and colorectal cancers, is being offered in China in partnership with BGI under the Chinese brand name Hua Jian Wei. The assay can help facilitate innovative trial design and enable biopharmaceutical researchers to make better informed and more timely decisions. Pharmaceutical companies can access this assay in China through the BGI-Natera partnership.