New Products

Oct 17, 2018

Trivitron Newborn Screening Tests

Slovakian diagnostics firm Trivitron LabSystems Diagnostics launched six newborn screening tests. They include the Neomass AACC Plus kit for the quantitative determination of 15 amino acids, free carnitines, 12 acylcarnitines, argininosuccinic acid, and succinylcetone under the same extraction method and single injection/single run step on tandem mass spectrometry; the CAH Mass Second Tier test kit, which measures 17-hydroxyprogesterone, cortisol, 11-deoxycortisol, and 21-deoxycortisol in dried blood samples; and the SCID-SMA Multiplex PCR kit for the rapid and simultaneious detection of severe combined immunodeficiency sydrome and spinal muscular atrophy, basd on DNA samples from whole blood or dried blood spots after DNA extraction.

Also launched were the NS496 Plus DBS Puncher for automating laboratory sample prep and to punch dried blood spot sampples into 96-well microplates for analysis; Neonatal T4 FEIA kit for screening of congenital hypothroidism by the quantitative determination of total thyroxine from dried blood spots; and the Neonatal GALT kit for screening of classic galactosemia by the quantitative determination of galactose-1-phosphate uridyl transerase from dried blood spots. 

Oct 15, 2018

Roche NGS Avenio Tumor Tissue Analysis Kits

Roche has launched three next-generation sequencing Avenio tumor tissue analysis kits for oncology research: the Avenio Tumor Tissue Targeted Kit, Expanded Kit, and Surveillance Kit. The new kits complement the company's NGS ctDNA kits. They use formalin-fixed paraffin-embedded tissue and have a workflow of five days. The Avenio Tumor Tissue Targeted Kit covers 17 genes to identify guideline-related biomarkers. The Avenio Tumor Tissue Expanded Kit is a 77-gene assay with both guideline-related and emerging biomarkers. The Avenio Tumor Tissue Surveillance Kit covers 197 genes and is intended for establishing a baseline for variants in longitudinal tumor burden monitoring.

Oct 10, 2018

Waters RenataDx Screening System

Waters has launched the RenataDx Screening System, which uses flow-injection tandem mass spectrometry for rapid, high-throughput analysis of extracted dried blood spots and other human biological matrices. The system can run on any FIA-MS/MS laboratory-developed test or ready-to-use reagent kit, Waters said, adding it incorporates the combination of the company's Xevo TQD IVD mass spectrometer, the Acquity UPLC I-Class IVD Binary Solvent Manager, and the 3777C IVD Sample Manager. It is manufactured as a US Food and Drug Administration Class I medical device and is CE marked.

Oct 09, 2018

MDNA Life Sciences Mitomic Prostate Test

MDNA Life Sciences has announced the UK release for its PCR-based Mitomic Prostate Test (MPT). The MPT is a liquid biopsy assay optimized for the early detection of prostate cancer in advance of biopsy. The firm designed the MPT for testing men with clinical suspicion of prostate cancer to determine their likelihood of clinically significant cancer that may benefit from rapid intervention. The test will run on MDNA's CE-IVD kit, which contains the needed reagents to process up to 21 patient samples at a time.

Oct 09, 2018

Singulex Clarity C. diff toxin A/B assay

Singlulex launched the Singulex Clarity C. diff toxin A/B assay, a rapid, high-sensitivity, high-precision, one-step solution that the company said matches the sensitivity and specificity of cell cytotoxicity neutralization assays. The test leverages Singulex's Single Molecule Counting technology to detect C. difficile toxins at an analytical sensitivity that detects 100 times lower concentrations than current immunoassays, the firm said, adding results can be obtained in less than 35 minutes. 

Oct 09, 2018

Vermillion OVA1(R)+

Vermillion launched its enhanced reflex offering OVA1(R)+ through its wholly owned subsidiary Aspira Labs. OVA1(R)+ combines the technologies behind the company's OVA1(R) and OVERA(R) offerings, which are used to evaluate the risk in women with a pelvic mass prior to surgical treatment of developing ovarian cancer. Patients who undergo OVA1(R)+ and show elevated OVA1(R) results will then have OVERA(R) performed. 

Oct 08, 2018

Ortho Clinical Diagnostics Kapa Free Light Chain, Lambda Free Light Chain, Methotrexate Assays

Ortho Clinical Diagnostics has launched its Kapa Free Light Chain and Lambda Free Light Chain assays in collaboration with Diazyme Laboratories. The assays are being made available through its MicroTip Partnership Assay program, which was established to validate third-party assays for use on Ortho Clinical's platforms. The company also said that it will offer the methotrexate assay in collaboration with Ark Diagnostics and Sekisui Diagnostics. 

The Kappa Free Light Chain and Lambda Free Light Chain assays are recommended for diagnosing and monitoring plasma cell disorders such as multiple myeloma, lymphoid neoplasms, and amyloidosis. The metrotrexate assay is for monitoring methotrexate, a drug prescribed to patients with certain neoplastic diseases, including osteogenic sarcoma, leukemia, non-Hodgkin's lymphoma, and breast and lung cancer, and others.

The three assays have been validated for use with Ortho Clinical's Vitros 5600 Integrated System and Vitros 4600 Chemistry System. The Kappa Free Light Chain and Lambda Free Light Chain assays will be available in the US, Europe, Middle East, and Africa. The methotrexate assay will be available in the US. 

Oct 04, 2018

Precipio HemeScreen

Precipio this week commercially launched HemeScreen, a test for mutations in hematologic cancers. The test measures for mutations in the CALR, JAK2, JAK2 exon 12, and MPL genes, which are critically important to developing the clinical roadmap for the patient, Precipio said. The company will offer the assay through its CLIA laboratory in New Haven, Connecticut, and will also offer a set of RUO reagents to other reference labs to perform the test in their CLIA laboratories.

Oct 04, 2018

HalioDx Brightplex

HalioDx launched Brightplex, a high-capacity immunohistochemistry multiplex technology for analyzing multiple biomarkers on a single formalin-fixed, paraffin-embedded slide. The first panel, Brightplex TCE, uses five biomarkers to identify exhaused T cells. The second panel, Brightplex MDSC, combines six biomarkers to identify different subtypes of myeloid-derived suppressor cells that have been difficult to identify by IHC. Additional panels will be developed based on the Brightplex technology, HalioDx said. 

Oct 03, 2018

Seq2Know Celiac Disease Testing

Seq2Know has begun offering celiac disease testing. The firm's test includes the sequencing of the DQA1 and DQB1 genes that have been associated with celiac disease. All tests will be ordered directly from Seq2Know.com and will be reviewed by PWNHealth to ensure the appropriateness of the test, the company said. 

Oct 03, 2018

Magnolia Medical Technologies Blood Collection Kit

Magnolia Medical Technologies launched a blood collection kit that combines the company's Steripath Gen2 Initial Specimen Diversion Device with other required supplies for the virtually contamination-free collection of blood culture samples. The kit was developed in partnership with Aero-Med, a division of Cardinal Health. Magnolia is guaranteeing a sustained reduction in blood culture contamination of 50 percent or more for all Steripath Gen2 products, and when used with the new blood culture kit and the 50 percent reduction has been surpassed, the company guarantees a .5 percent contamination rate. Magnolia is backing its claim with a $1,000 credit for any contaminiation event with th gurantee thresholds. 

Oct 01, 2018

Beckman Coulter Kaluza C Flow Cytometry Analysis Software

Beckman Coulter has launched the Kaluza C Flow Cytometry Analysis Software for the clinical lab. The company said the FDA-listed and CE-marked data analysis system streamlines clinical QC reporting and addresses standardization issues in flow cytometry. 

Sep 28, 2018

MNG Xpress Exome

MNG Laboratories has launched the MNG Xpress Exome, a diagnostic exome sequencing test to identify mutations in Mendelian disorders. The test, which has a turnaround time of 10 to 14 days, costs $4,895 for a trio and $3,295 for proband-only testing.

Sep 24, 2018

Roche FoundationOne Liquid

Roche has globally launched Foundation Medicine's FoundationOne Liquid, a liquid biopsy test that can identify 70 of the most commonly mutated genes in solid tumors, as well as microsatellite instability. The test complements FoundationOne CDx, the company's tissue-based genomic profiling test, and is different from FoundationAct, the firm's first liquid biopsy assay, which analyzed 62 genes and did not report MSI.

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.

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