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Oct 15, 2019

HTG Molecular HTG EdgeSeq Autoimmune Panel

HTG Molecular said it is now taking orders for its new HTG EdgeSeq Autoimmune Panel, which it expects to commercially launch in kit form or as a service at the end of October. The firm said it has designed the panel to address questions around autoimmune disorders, as well as for examining immune system dysfunction, discovering new biomarkers, and discovering predictive signatures of drug responses in the autoimmune space. 

Oct 15, 2019

LGC Maine Standards Validate LP2 Linearity and Calibration Verification Kit

LGC Maine Standards launched the Validate LP2 linearity and calibration verification kit for Roche Cobas analyzers. The kit, which is in a human serum matrix, is used to assess apoliprotein A and apoliprotein B. Each kit offers five concentrations covering the reportable range and can be used to augment daily QC and assist with fulfilling various quality control requirements for linearity and calibration verification under CLIA '88, the College of American Pathologists, COLA, Joint Commission on Accreditation of Healthcare Organizations, Joint Commission International, and ISO 15189, LGC Maine said. 

Oct 14, 2019

Predictive Laboratories FertilityDX

Predictive Laboratories launched FertilityDX, a genetic testing service that allows physicians to tailor fertility treatments. The test provides information in three areas, the firm said — causes of infertility, risks of pregnancy complications, and risks for serious genetic conditions in the offspring. As part of the service patients are provided pretest counseling, and physicians received an easy-to-understand final report, as well as access to genetic consultants. 

Oct 14, 2019

PerkinElmer PG-Seq Rapid Non-Invasive Preimplantation Genetic Testing Kit

PerkinElmer launched the PG-Seq Rapid Non-Invasive Preimplantation Genetic Testing for Anueploidy kit, which tests spent embryo culture media for chromosomal abnormalities during in vitro treatment. Preimplantation genetic testing for aneuploidiy is used to identify viable embryos and has typically involved a biopsy by creating an opening in the outer coating prior to removal and testing a few cells. Recent studies have demonstrated, however, that an embryo releases small amounts of DNA into the culture media in which it is growing, allowing for the surrounding fluid to be genetically tested. PerkinElmer's kit tests the spent embryo culture to detect aneuploidies and structural rearrangements, including unbalanced translocations and segmental errors.

Oct 11, 2019

Sema4 Expanded Carrier Screening

Sema4 has launched a larger Expanded Carrier Screen for family planning with personalized residual risk.

The test analyzes 502 genes associated with clinically relevant conditions, up from 283 genes, to cover more rare diseases. The test detects more high-risk pregnancies and identifies up to 30 times more carrier couples, Sema4 CEO Eric Schadt said in a statement. It also incorporates low-pass genome analysis to detect ancestry markers that to refine the accuracy of results.

Oct 10, 2019

Predictive Laboratories ARTguide Test

Salt Lake City, Utah-based Predictive Laboratories has commercially launched its ARTguide DNA-based blood test, which examines the risk for endometriosis and other genetic causes of infertility in women. According to the firm, the test identifies hundreds of genetic markers of endometriosis and 80 other additional mutations causing conditions that may impact fertility.  

Oct 10, 2019

Co-Diagnostics Vector Smart ZDC Test

Co-Diagnostics has commercially launched its Vector Smart ZDC test, which is used to identify the presence of Zika, dengue, and chikungunya in mosquito populations. The firm said that its line of Vector Smart PCR products are validated using extractions from mosquito samples to reduce the possibility of a false negative result due to improper extraction. 

Oct 01, 2019

NanoString nCounter Human Organ Transplant Panel

NanoString Technologies has launched its nCounter Human Organ Transplant panel, a new gene expression panel for evaluating the immune response following organ transplantation. The firm said that it created the assay in collaboration with the Banff Foundation for Allograft Pathology. The panel covers 770 genes and is customizable. It is designed for use with the predominant transplant organs including kidney, heart, lung, and liver. Genes included on the panel are involved in 37 pathways that are components of the immune response, tissue injury, and mechanisms of action for immunosuppressive drugs. The panel also includes probes to detect common viral infections that can cause issues with transplants, including BK polyomavirus, cytomegalovirus, and Epstein-Barr virus.

Oct 01, 2019

Ambry Genetics +RNAinsight

Ambry Genetics has launched +RNAinsight, a combined DNA and RNA genetic test for hereditary cancer syndromes that is designed to return more certain results to patients by using RNA sequencing to definitively classify otherwise ambiguous genetic alterations. While the RNA aspect of the test does not include all known cancer risk genes, it does focus on a subset that includes BRCA1 and 2, TP53, PTEN, and PALB2, among others. Ambry said that the turnaround time for the combined test matches the company's DNA-only hereditary cancer panel.

Sep 30, 2019

T2 Biosystems T2Resistance Panel

The T2 Biosystems T2Resistance Panel for genotypic antibiotic resistance marker testing is now available as a research use only test in the US. The panel uses the firm's T2Dx instrument and identifies 13 genes conferring resistance to common empiric antibiotic therapies, such as carbapenems, vancomycin, and penicillin, directly from whole blood within three to five hours. The panel received breakthrough device designation from the US Food and Drug Administration earlier this year and is on track to receive CE mark by the end of 2019.

Sep 30, 2019

HiberGene Diagnostics HG RSV A/B Combo Test

HiberGene Diagnostics has launched its HG RSV A/B Combo test, which uses nasopharyngeal swabs for the direct detection of the respiratory syncytial virus in less than 60 minutes. HiberGene said its multiplexing technology delivers a differential diagnosis between A and B subtypes to facilitate best treatment options.

The RSV product brings to 10 the number of tests that can be used with HiberGene’s lightweight HG Swift analyzer. The HiberGene product menu spans hospital-acquired infections, sexually transmitted diseases, and critical infectious diseases, and the tests are suitable for use in near-patient settings.

Sep 25, 2019

Roche Cobas EBV, BKV Tests

Roche has launched the Cobas EBV and BKV tests for Epstein-Barr virus and BK virus in countries accepting the CE mark. The tests are for use with Roche's Cobas 6800/8800 Systems. The real-time PCR tests leverages dual target technology help clinicians manage the risk of infection for severely immunocompromised transplant patients and assess if these patients are at risk of of developing disease, which can contribute to organ rejection, the company said. 

Sep 19, 2019

Instrumentation Laboratory HemosIL AcuStar ADAMTS13 Activity Assay

Instrumentation Laboratory has launched the HemosIL AcuStar ADAMTS13 Activity Assay in the EU and other international markets. The assay is for use with the ACL AcuStar Hemostasis Testing System. The fully automated, chemiluminescent immunoassay provides clinicians rapid, on-demand ADAMTS13 activity testing for aid in diagnosing and monitoring thrombotic thrombocytopenic purpura. First results can be obtained in about 30 minutes, Instrumentation Laboratory said. 

Sep 18, 2019

Yourgene Elucigene DPYD

UK-based Yourgene has launched the Elucigene DPYD assay, a CE-marked chemotoxicity diagnostic test that uses genotyping to identify cancer patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The deficiency causes several and sometimes lethal side effects in patients treated with 5-fluorouracil (5-FU), which is metabolized by the DPD enzyme, encoded by the DPYD gene. Elucigene DPYD, which tests for six common genetic variations, conforms with Clinical Pharmacogenetics Consortium guidelines, which recommend testing for four clinically relevant mutations.

Sep 04, 2019

Xifin LIS 6

Xifin has introduced a new version of its laboratory information system, Xifin LIS 6. The latest iteration of the software-as-a-service platform includes several features resulting from recently formed partnerships. Notably, Xifin LIS 6 includes artificial intellegence-driven genomic data interpretation, thanks to a partnership with Fabric Genomics. The new release supports fast, scaleable analysis of next-generation sequencing to produce "physician-ready" clinical reports, the company said.  

Other upgrades in LIS 6 include support for digital pathology workflows via a collaboration with Proscia, integration of Glidian's automated prior authorization technology, and access to test utilization support from the Medical Database LDS laborator decsion system.

Aug 26, 2019

Aria Diagnostics: SynCheck

Aria Diagnostics has launched SynCheck for detecting synthetic and adulterated urine. The Indianapolis-based company said the test can be used for opioid-use detection, and it will provide SynCheck to physicians and rehab centers for free. 

Aug 07, 2019

OmniPathology FISH test for HPV-related cancer

OmniPathology has announced a new fluorescence in situ hybridization test to detect human papilloma virus (HPV)-related cancer.

The test detects fluorescent-labeled DNA probes bound to the TERC gene locus at chromosome location 3q26. It can be used for early detection of malignant and premalignant conditions in both male and female patients.

Aug 05, 2019

PerkinElmer Euroimmun Aspergillus Antigen ELISA

PerkinElmer has launched the Euroimmun Aspergillus Antigen ELISA for detection of the Aspergillus antigen galactomannoprotein and aid in distinguishing invasive apergillosis. Eurommun CEO Wolfgang Schlumberger said in a statement that when processed using the automated Euroimmun Analyzer system, the Euroimmun Aspergillus Antigen ELISA "seamlessly" integrates into a lab workflow, resulting in quicker detection of Aspergillus infections at an earlier stage. Euroimmun is a PerkinElmer company.

Jul 31, 2019

Mesa Biotech RSV

San Diego, California-based molecular diagnostics developer Mesa Biotech has launched a respiratory syncytial virus test on its sample-to-answer point-of-care PCR system, the Acula. The RSV test is the second test on the system, which also runs an influenza A/B test and is exclusively marketed in the US by Sekisui under the Silaris brand. It was cleared by the US Food and Drug Administration and CLIA-waived last year for diagnostic use in both children and adults.

Jul 17, 2019

Bio-Techne 32X8 Cartridge for the Ella Platform

Bio-Techne announced the launch of a new eight-plex cartridge format for its ProteinSimple-branded Ella automated immunoassay platform. The 32x8 cartridge for Ella enables users to build panels of up to eight analytes, selected from a pool of pre-validated analytes that are putative biomarkers for a variety of diseases, including inflammation and cancer. These multiplex assays are validated to the same high standards of a single-plex assay, allowing users to seamlessly transition between plex levels and cartridge formats, the firm said.

Jul 16, 2019

Abbott Configurable Molecular Workflows

Abbott launched a laboratory information management system, Starlims Life Sciences Solution 11.1, to help manage complex sample and testing workflows, and to help drive data safety and integrity throughout the testing lifecycle.

Starlims Life Sciences Solution 11.1 is designed for pre-clinical, clinical research, biorepository, animal health, molecular, specialty diagnostics, and academic research applications that manage and test clinical samples.

Abbott said that the solution gives customers the flexibility to self-configure a wide choice of assays in an integrated fashion within the firm's biorepository, inventory, and quality control products.

Jul 16, 2019

OptraScan OS-SiA Digital Scanner

OptraScan has launched the OS-SiA, an AI-enabled digital scanner that automatically and simultaneously scans and analyzes tissue slides. The scanner can be embedded in OptraScan's series of cloud-enabled 15- to 120-slide brightfield scanners. According to the company, the analyzed information serves as a reference heatmap to guide users to a high level view of the tumor, rare events, or other areas of importance. The digitized images taken from OS-SiA can be viewed in local, web-based, mobility-based image viewers.

Jul 15, 2019

NanoString Alzheimer’s Disease Research Panels

Seattle-based NanoString Technologies has developed a set of new nCounter gene expression panels for use in Alzheimer's disease research, which it created and tested in collaboration with the MODEL-AD consortium. The two panels — one for use in mouse studies and another for human studies — measure the expression of 770 genes covering 30 modules discovered in a recent study of human brain tissue. The firm noted that both panels are available for purchase through its website.

Jul 12, 2019

PerkinElmer Anti-Borrelia, Anti-EBV/EBNA Assays

PerkinElmer launched two assays for detecting anti-Borrelia (Lyme diesase) and anti-EBV/EBNA (Epstein-Barr-Virus) antibodies. Both assays were CE marked in late May and run on the Euroimmun RA Analyzer 10 system, an automation solution for small and medium-sized labs. It also complements high-throughput devices in large labs. 

Jul 02, 2019

ZeptoMetrix NATtrol Respiratory Verification Panel

ZeptoMetrix has released the NATtrol Respiratory Verification Panel, a 20-member respiratory panel for use by laboratories in QC applications with molecular diagnostics for infectious disease testing. ZeptoMetrix was founded in 1999 and is based in Buffalo, New York.

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