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The company attributed the revenue decline in part to working capital restraints and long manufacturing lead times, which are being addressed currently.

OvaCis is a CE-IVD marked in vitro diagnostic that can be used to assess epithelial ovarian cysts.

 

The Access PCT assay can help clinicians assess patients in danger of severe sepsis or septic shock and delivers results in less than 20 minutes. 

The firm said it anticipates using the financing for further commercialization and expansion of its infectious disease testing vertical, among other activities.

Atrin will use Predictive's GenDB databases and women's health biobank to study germline mutations in DNA damage and response inhibitor pathways. 

CEO Prahlad Singh said the firm is developing a PCR- and antibody-based assay for the novel coronavirus 2019-nCoV and is working with the Chinese NMPA.

The final national coverage decision stipulates that NGS germline tests for assessing hereditary breast and ovarian cancer risk must have FDA's blessing.

The company's Lyo-Ready 1-Step RT-qPCR mix is being used by diagnostic labs in China to develop screening assays for the virus.

Memorial Hermann's outreach sites will transfer testing to Quest's Houston lab and the firm will also provide management services for the system's 21 hospital labs.

The pharmacogenetic test, which runs on a platform from British company Genedrive, will be tested in two neonatal intensive care units in Manchester and Liverpool.

The agency plans to make test kits available to state and international partners in the next two weeks. It also provided updated information about the virus.

Natera alleged that certain cell-free DNA-based oncology products sold by Archer Dx infringe its US Patent 10,538,814, which was issued earlier this month.

The company said it has started the CE mark approval process of commissioned high-risk HPV genotyping assays and expects to certify them this year.

The partners will use Noscendo's Disqver next-generation sequencing-based diagnostic platform to characterize antibiotic-resistant pathogens.

The company, which is developing an assay for the 2019-nCoV coronavirus, is offering about 3.5 million shares of its common stock at $1.45 per share.

The Seattle-based immune sequencing firm will not receive any proceeds from the sale of the shares.

News items for the in vitro diagnostics industry for the week of Jan. 20, 2020.

The Stockholm-based company said it will use the funds to develop its metabolism-based liquid biopsy platform.

Myriad filed an sPMA for myChoice CDx despite GSK's confidence that Zejula will be approved in newly diagnosed ovarian cancer regardless of biomarker status.

The reagent is used for the detection of cytokeratin 19 mRNA in surgically removed sentinel lymph nodes in order to diagnose lymph node metastasis.

FIND said that the consortium will evaluate the impact on clinical trial participants of innovative diagnostic technologies versus current standards of care.

Abbott said the increase in diagnostics revenue was driven by adoption of the company's Alinity family of diagnostic instruments.

The partners will extend the lung cancer biomarker study to countries in and outside Europe, and see if liquid biopsy could offer benefits to tissue-based testing.

The devices are used for collection and stabilization of saliva samples for genetic testing, such as diagnostic testing or direct-to-consumer use.

Blueprint provides 3,900 targeted single-gene and more than 200 panel tests covering 14 medical specialties, leveraging NGS and bioinformatics methods.

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