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Owlstone Medical Breath Biopsy Kits

Mar 28, 2018

Owlstone Medical has launched its Breath Biopsy Kits. The kits are based on the firm's Breath Biopsy platform, which detects volatile organic compound markers in breath. The kits will allow academic, clinical, and pharmaceutical research to quickly discover and validate breath-based biomarkers for detection and precision medicine research, it said. Earlier this month, the company said that it raised $15 million for the commercialization of its breath-based diagnostic technology. Owlstone aims to bring tests for lung cancer, colorectal cancer, and asthma to market on its Breath Biopsy platform in coming years.

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Sep 18, 2019

Yourgene: Elucigene DPYP

Yourgene has launched the Elucigene DPYP 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 DPYP, 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

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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

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Jun 28, 2019

BillionToOne Unity Prenatal Screen

BillionToOne has commercially launched its Unity prenatal screening assay. According to BillionToOne, the assay is powered by its molecular counting technology and is the only prenatal screen that tests cell-free fetal DNA for cystic fibrosis, spinal muscular atrophy, and sickle cell disease using only one tube of the mother's blood. The firm said it will make the test available at select clinics through its early access program, with plans for a broader commercial launch later this year. 

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Co-Diagnostics announced the launch of its Logix Smart ZDC multiplex test at the 64th Annual 2019 Caribbean Public Health Agency Health Research Conference in Trinidad and Tobago.

The firm designed the ZDC multiplex test to detect the presence of Zika, dengue, and chikungunya within a single polymerase chain reaction assay. The firm said that the performance of the test confirms the heightened specificity provided by its CoPrimer platform in multiplex PCR applications. Co-Diagnostics received CE marking for the ZDC multiplex test in the first quarter after validating its performance, permitting its marketing throughout the European Community, Latin America, the Caribbean Basin, and other jurisdictions that accept the CE designation.

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