Meridian Bioscience ImmunoCard Stat Flu A&B

Aug 08, 2017

Meridian Bioscience today released its ImmunoCard Stat Flu A&B, an expansion of its ImmunoCard Stat product line. The product will detect the presence of influenza A & B in nasal and nasopharyngeal swabs, and can also be used to test nasal washes and aspirates. According to the company, the device will require a simple procedure with minimal interaction time that provides qualitative results in 10 to 15 minutes.

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Sep 20, 2018

Precipio EGFR Liquid Biopsy Kit

Precipio has launched a new liquid biopsy ICEme kit, which uses the company's ICE-COLD PCR technology to enrich and detect cancer mutations in EGFR exons 18, 19, 20, and 21. The kit uses either qPCR or Sanger platforms with sensitivity down to 0.1 percent allele frequency. The new product complements Precipio's previously-launched TKI-resistance detection kit, which includes assays for EGFR exon 20 T790M and C797S resistance mutations.

Sep 19, 2018

Circulogene BRCA1/2 Testing

Circulogene has included somatic BRCA1 and BRCA2 blood testing to its testing menu. The addition of somatic BRCA1/2 testing allows the company to perform paired somatic and germline testing, the Birmingham, Alabama-based molecular diagnostics firm said. The paired testing is a single blood-tube test that can detect acquired mutations and inherited variants in patients with advanced breast, ovarian, and other cancers.

Sep 18, 2018

Roche Navify Clinical Trial Match, Navify Publication Search

Roche has launched two Navify clinical decision support apps, Navify Clinical Trial Match and Navify Publication Search, to help oncologists access clinical trial information and publications. Both are available on the Navify Tumor Board platform.

The Navify Clinical Trial Match app identifies clinical trial options from 11 international registries, based on patient-specific attributes such as age, sex, biomarkers, and various tumor attributes. The registries include ClinicalTrials.gov, the German Clinical Trials Registry, and the European Clinical Trials Registry. The Navify Publication Search app mines several publication sources, including PubMed, the American Society of Clinical Oncology, and the American Association of Central Cancer Registries, for relevant literature. The content of both apps is provided by MolecularMatch, a clinical informatics company.

Roche said it plans to add more apps, including from partners and third parties, in the future.

Sep 13, 2018

Viracor Eurofins CMV Resistance:Letermovir

Viracor Eurofins has launched CMV Resistance:Letermovir, a cytomegalovirus gene sequencing assay for the detection of resistance to Prevymis (letermovir), an antiviral for use in adult hematopoietic stem cell transplant patients. The assay is available as a standalone test or as a complete panel with the other CMV drugs as CMV Resistance: Letermovir, Ganciclovir, Foscarnet, Cidofovir. Viracor Eurofins said that resistance to Prevymis has not been detected in treatment-naive patients, but noted that clinical trials have shown that resistance can develop in the UL56 gene after exposure for some HSCT patients. 

Sep 11, 2018

Exagen Diagnostics Anti-CarP Test

Exagen Diagnostics has made available a validated blood test to detect autoantibodies against carbamylated proteins. Elevated levels of anti-CarP antibodies suggest a more severe form of RA, and studies have demonstrated the anti-CarP test can help in the managment of rheumatoid arthritis, the company said. 

Sep 10, 2018

Instrumentation Laboratory ProDx Remote Support Suite

Instrumentation Laboratory has launched the ProDx Remote Support Suite for the continuous monitoring of the company's ACL TOP Hemostasis Testing Systems in hospitals and commercial laboratories. The suite enables remote analzyer diagnostics, rapid and tailored technical support and resolution, IL said. It connects ACL Top Hemostasis Testing Systems in use at customer sites to the ProDx Secure Data Center through a virutal private network, allowing technical support and service specialists to identify potential problems before they happen and perform preventive actions. 

Sep 10, 2018

Inspirata Dynamyx Digital Pathology Software

Inspirata announced an update to its Dynamyx digital pathology software, a web-based platform that supports multisite collaboration between pathologists and care teams. Written in HTML5, the new version 2.0.7 also seeks to bridge language barriers by facilitating linguistic localization in English, German, Spanish, and Portuguese. Like previous versions of Dynamyx, the new release can import bright-field images from a wide range of scanners, including those from 3DHistech, Aperio/Leica, Hamamatsu, and Philips, Inspirata said.

Sep 10, 2018

Beckman Coulter Remisol Advance

Beckman Coulter released the newest software version of its middleware system called Remisol Advance. Enhancements to the product allow for the real-time, holistic view of laboratory operations at any given moment through a centralized dashboard that combines sample status information, turnaround data, and quality control alerts, the company said. 

Sep 06, 2018

Philips TissueMark

Royal Philips has released a new version of TissueMark, its computational pathology software. The update extends tumor sufficiency guidance to whole-slide images of adenocarcinoma prostate tissue and high-grade serous carcinoma ovarian tissue, functionality previously only available for lung histology, lung cytology, colon, and breast tissue. TissueMark is compatible with Philips' HealthSuite artificial intelligence platform, launched earlier this year.

Sep 04, 2018

Genoptix BCR-ABL MRDx TFR Monitoring Test

Genoptix has released its BCR-ABL MRDx TFR Monitoring Test for patients with chronic myeloid leukemia being treated with Tasigna. According to the firm, the assay is the only diagnostic  test authorized by the US Food and Drug Administration for managing patients on tyrosine kinase inhibitors. 

Aug 31, 2018

Viracor Eurofins aGVHD Algorithms

Viracor Eurofins announced the launch of predictive acute graft-versus-host disease (aGVHD) algorithms to help identify at-risk patients.

aGVHD is a major complication following allogeneic hematopoietic cell transplantation (allo-HCT). Accurate and early identification of patients at high-risk for severe aGVHD and related complications has the potential to improve patient outcomes. High risk patients can be preemptively treated for aGVHD prior to the onset of clinical disease, while low-risk patients may potentially avoid unnecessary treatment.

Viracor's new aGVHD algorithm testing, which uses the Mount Sinai Acute GVHD International Consortium (MAGIC) algorithm, was developed by James Ferrara and John Levine, both professors of pediatrics, medicine, hematology and medical oncology at the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai, and validated in conjunction with 17 hematopoietic cell transplantation centers. The aGVHD predictive algorithms use serum levels of ST2 and regenerating islet-derived 3-alpha biomarkers, which are interpreted through the MAGIC algorithm using clinically validated cutoff values specific to the time of sample collection and/or the patient's condition. Use of these predictive algorithms have been demonstrated to be accurate despite variations in clinical factors that increase the risk of non-relapse mortality post-transplant.

Viracor's three algorithms have been validated to risk stratify severe aGVHD and NRM at distinct events post-allogeneic HCT. The aGVHD presymptomatic algorithm is for use approximately seven days post-transplant, and before the patient shows onset of aGVHD symptoms. The aGVHD symptomatic onset algorithm is for use post-transplant after the patient begins to display symptoms of aGVHD. The aGVHD post-treatment algorithm is for use approximately seven days or more after systemic treatment for aGVHD has been initiated.

Viracor delivers results of these testing algorithms to physicians within 24 hours of receiving the specimen.

Aug 29, 2018

Xifin LIS 5

Xifin has launched the latest version of its lab information system, the Xifin LIS 5. The software-as-a-service-based platform includes multi-specialty workflows for molecular and next-generation sequencing. It also includes universal image management, a digital pathology consultation function, and a feature to facilitate multidisciplinary care team coordination.

Updates to the system's existing NGS module provide more specimen management, user-defined workflow steps, and the ability to support multiple lab processes. The platform's enhanced clinical trials support system now provides a project-oriented workflow. An enhanced anatomic pathology module improves the speed and functionality of new specialty workflows for gynecologic cytology, urology, and GI applications. The molecular diagnostic and genomics workflows now support FISH, gene microarray, and PCR, as well as NGS pharmacogenomics testing.

Aug 22, 2018

Sema4 NIPT and Expanded Carrier Screening Tests

Sema4 has launched a noninvasive prenatal test and an expanded carrier screening test, which it developed using its Sema4 Health Intelligence Platform. The NIPT is available in three options: a standard panel that tests for trisomies 21, 18, and 13; a standard plus panel that also includes trisomies 15, 16, and 22, as well as sex chromosome aneuploidies; and an expanded panel that includes all of the above plus some microdeletions.

The expanded carrier screen can test more than 280 genes, including 101 genes associated with Jewish founder mutations. Patients also have the option of analyzing a smaller subset of genes.

Aug 22, 2018

Seq2Know Familial Hypercholesterolemia Testing

Seq2Know has begun offering familial hypercholesterolemia testing. Its test includes the sequencing of four genes — LDLR, APOB, PCSK9, and LDLRAP1 — that cause FH. Like all of Seq2Know's tests, the FH test is ordered directly from the company and reviewed by PWNHealth, an independent physician network, for patient appropriateness. Genetic counseling is also available through PWNHealth. Seq2Know is a testing service of PreventionGenetics, a DNA testing lab offering genetic sequencing services.

Aug 22, 2018

Abreos Biosciences moNATor

Abreos Biosciences has launched its first commercial product, moNATor, a laboratory-developed test for use by physicians to monitor Tysabri (natalizumab) levels in patients with multiple sclerosis. The test is now commercially available in the US. Abreos' flagship technology is called Veritope, which identifies proprietary peptide-based ligands that can measure and purify biologic molecules. Veritope provides for the selective monitoring of therapeutic antibody drugs, allowing physicians to optimize therapeutic dose and timing.