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In Brief This Week: Ventana; Paradigm; Thermo Fisher; Transgenomic; Atossa Genetics; SQI; 908 Devices

NEW YORK (GenomeWeb) – Roche's Ventana Medical Systems said that its Ventana System for Primary Diagnosis has received CE marking in the European Union for routine pathology, including primary diagnosis with human tissue specimens. The system comprises the Ventana Virtuoso software combined with either the Ventana iScan Coreo or the Ventana iScan HT slide scanner for the automated creation of digital slides, as well as automated case management and computer viewing of human tissue specimens. The iScan Coreo slide scanner is a brightfield 160-slide capacity scanner. The iScan HT slide scanner is a high-throughput brightfield slide scanner with a 360-slide capacity.


Paradigm is collaborating with Tesaro to better predict which patients may be sensitive or resistant to Tesaro's therapeutic candidate, TSR-011, which may have applications in oncology indications, including ALK-positive non-small cell lung cancer and other tumors with ALK or TRK mutations. Ann Arbor, Mich.-based Paradigm said it will use its molecular capabilities to characterize patient tissue samples from clinical trials as part of the collaboration. It added that the deal may lead to improved clinical trial outcomes and opportunities for Paradigm to develop and commercialize potential diagnostic products.


Thermo Fisher Scientific has completed the sale of its Cole-Parmer customer channel business to private equity firm GTCR for about $480 million in cash.


Transgenomic said in its Form 10-Q filed with the US Securities and Exchange Commission that its 2013 agreement with PDI to promote Transgenomic's CardioPredict test has expired automatically. The molecular diagnostic test identifies specific genes that influence the safety and effectiveness of commonly used cardiovascular drugs. Transgenomic said that management continues to believe the test "continues to have good commercial potential and is evaluating commercialization options."


Atossa Genetics has submitted additional information to the US Food and Drug Administration related to its 510(k) submission for the ForeCYTE Breast Aspirator. The company filed its submission in December 2013 after voluntarily recalling the breast cancer test device two months earlier amid concerns raised by the FDA. This past February, the FDA requested more information from the company. Atossa's response includes data from an IRB-approved prospective, single-arm, multi-laboratory, non-randomized, non-masked clinical trial in adult women using the device. Also, it submitted a study of the concordance of positive and negative control reference panel specimens, and study data establishing shelf-life information and document shipping stability under adverse conditions for the ForeCYTE Breast Aspirator.


SQI Diagostics has entered into a master service agreement with an unnamed UK company to automate its DNA-based pathogen detection assays. SQI will initially be paid to deliver an automated working prototype of the customer's assays that is operational on SQI's sqidlite system. The first assay being automated is for identifying pathogens in raw dairy milk. The initial phase is anticipated to be completed by the middle of next month, and SQI said that it expects other molecular diagnostic tests will be commissioned in a separate agreement after the initial phase is successfully implemented. Financial and other terms of the deal were not disclosed.


Miniature mass spectrometry firm 908 Devices said it has expanded its offices from a 7,000-square-foot R&D think tank into a 16,000-square-foot full-scale product facility. The Boston facility includes a full machine shop, analytical and R&D laboratories, clean room, and collaborative meeting spaces.


In Brief This Week is a Friday column containing news items that our readers may have missed during the week.

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