Myriad Genetics on Monday launched a new version of its MyRisk Hereditary Cancer test that provides a polygenic risk (PRS) score to all breast cancer patients regardless of their ancestry. The company's MyRisk next-generation sequencing test analyzes 35 genes associated with eight hereditary cancers. Meanwhile, RiskScore, the PRS test, analyzes 140 SNPs that together can enhance the breast cancer risk assessments from MyRisk.
Since 2017, Myriad has been providing a RiskScore only to women who self-identified as having European and Ashkenazi Jewish ancestry, and who test negative on MyRisk for known high-risk cancer gene mutations. However, the company recently recalibrated RiskScore for all ancestries. "Women who previously took the MyRisk test since 2017 and were unable to benefit from RiskScore due to genetic ancestry, will now be offered the opportunity to have their risk assessment updated by Myriad Genetics free of charge," the company said in a statement.
With the pan-ancestry PRS added, the company is hoping to provide accurate breast cancer risk assessments to more women. Around 95 percent of women test negative for mutations in genes known to increase their predisposition for cancer, even though they still may be at increased risk for the disease. But now, the company estimates that more than half of the patients tested on MyRisk and RiskScore may qualify for increased screening or risk-reducing interventions.
SpeeDx has launched a SARS-CoV-2 variant analysis assay for research use only. The PlexPrime SARS-CoV-2 Alpha/Beta/Gamma+ assay is a single-well multiplex test designed to detect mutations N501Y, S982A, and E484K in the spike gene of SARS-CoV-2. These mutations are found in the alpha (B.1.1.7), beta (B.1.351), and gamma (P.1) variants of concern. The test is compatible with standard qPCR instrumentation. It can potentially reduce the manual process of preparing positive samples for sequence analysis by identifying samples of interest, ultimately reducing turnaround and hands-on time, the company said. The firm also plans to launch a multiplex assay for mutations related to the delta variant, and is currently assessing other mutations.
Galaxy Diagnostics has launched the Bartonella IFA Serology (IgG) panel. The antibody test detects exposure to four zoonotic Bartonella species – Bartonella henselae, Bartonella quintana, Bartonella koehlerae, and Bartonella vinsonii berkhoffii. According to Galaxy, the test identifies positive cases missed by conventional antibody testing, and detects IgG antibodies against the four most common Bartonella species implicated in human disease.
Ortho Clinical Diagnostics launched its Vitros Immunodiagnostic Products IL-6 Reagent Pack in the UK and countries in the European Union and Asia Pacific and Latin America regions.
Results from Ortho's IL-6 assay can be used to help healthcare teams detect and evaluate inflammatory diseases, including autoimmune disorders, sepsis, cases of severe respiratory infections from COVID-19, and community-acquired pneumonia in critically ill patients.
Ortho said its new IL-6 assay offers earlier detection of inflammation than c-reactive protein and is a cost-effective diagnostic complement to procalcitonin testing, both of which help monitor the body's inflammatory response in severely ill patients.
Pataign has introduced the research-use-only BACLIB Rapid Lipid Extraction Kit for microbial identification and colistin resistance detection, compatible with Bruker MALDI mass spectrometers. The kit can be used to identify bacterial species in about 30 minutes with a single assay involving less than a minute of hands-on time per sample, with no centrifugation or complex handling steps. The kit also identifies and determines colistin resistance for all the ESKAPE pathogens and includes access to custom software for ID/resistance determination.
PixCell Medical has appointed Armin Schon its chief commercial officer, effective immediately. He will oversee the Israel-based firm's global partnerships, all sales and marketing operations, and distribution of PixCell's point-of-care hematology analyzer, HemoScreen. Schon has more than 20 years of experience in the global sciences industries and medical device companies and was previously CEO of Trialog Clinical Trials. He was also CEO of El-Mul Technolgies and served as the Asia-Pacific region director of business development for Philips Medical Systems, and was corporate VP of strategy and business development at Orbotech.
LGC Seracare has launched the Seraseq ctDNA MRD Panel Mix reference material designed for use in patient-derived cell-free DNA minimal residual disease next-generation sequencing assays. The product was developed by combining a diseased cell line, its SNP-matched normal cell line, and biosynthetic DNA variants of clinical utility and/or targeted therapeutics, the company noted. The reference material is offered as a purified mutation mix ready for sequencing library prep with no additional extraction or purification step, according to the company.
Accelerate Diagnostics has launched a new configuration of its Accelerate PhenoTest BC kit in the US that provides antimicrobial susceptibility testing (AST) results in approximately seven hours from positive blood cultures. The new option runs on the Accelerate Pheno system as a solution for laboratories that already have a rapid identification system. The firm's US Food and Drug Administration-cleared Accelerate PhenoTest BC kit is an integrated product for labs needing both fast identification and fast AST.
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.
Thermo Fisher Scientific has launched the Thermo Scientific SpeciMAX Saliva Collection Kit to support large-scale research and surveillance programs of SARS-CoV-2 outbreaks and emerging new strains.
While most approved methods for SARS-CoV-2 saliva collection use specialized tubes and buffers for RNA stabilization and virus inactivation, the SpeciMAX Saliva Collection Kit is designed to provide a widely available, cost-effective solution for raw saliva collection to simplify saliva-based testing, the company said. The easy-to-use self-collection kits facilitate clean saliva transfers, reduce risk of cross-contamination when paired with liquid handlers, and fit into viral RNA extraction and direct-to-PCR downstream automation workflows for high-throughput surveillance testing.
The individually packaged and barcoded kits require just 1 mL of saliva and include a funnel and cap to secure the sample for processing. The standardized collection tube size can hold 6 mL of sample volume but requires less refrigeration, incubation, and storage space than other collection kits available on the market, Thermo Fisher added. The company also noted that the kit is currently for research use only, and isn't authorized for use in diagnostic procedures.