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The test is immunoassay-based and detects multiple targets using the firm's automated testing system called the BioPlex 2200.

The company recorded its first product sales in 2018 as it received CE-IVD marking of diagnostic tests for Zika and other infectious diseases.

The company said it has faced competitive pressures in its diagnostics business, partially offset by organizational streamlining efforts it initiated last year.

Bluejay said that the collaboration will focus on the study of antigens associated with various pathogens and identifying the most immunoreactive antigen.

The agency plans to evaluate newer RDTs in the future, and it is collaborating to bring molecular testing nearer to patients.

The FDA said that the final rule is designed to ensure that manufacturers continue to use appropriate practices for Bacillus detection tests.

Specific Diagnostics said that the CARB-X funding will enable it to prepare its AST instrument for clinical trials and regulatory validation.

Genfit expects to use part of the gross proceeds from the offering to advance the commercial development of a diagnostic test to identify patients with nonalcoholic steatohepatitis.

Group K said that the partners are developing a RT-LAMP system for use at the point of care in resource-limited areas where real-time RT-PCR is not available.

The test detects genomic drug resistance mutations in HIV-1 that can lead to treatment failure and is validated on the firm's automated Sentosa workflow. 

Proceeds will be used for the anticipated regulatory submission of its gene panel test for urinary tract infections and drug resistance, among other things.

Under the agreement, Menarini will immediately begin distributing Curetis' PCR-based system in Germany, France, Benelux, the UK, and Switzerland.

Based on PCR technology acquired from Hain Diagnostics, the test and platform enable rapid detection of TB, as well as assessment of antibiotic resistance.

The test detects Group A Strep in throat swab samples using the firm's rapid molecular diagnostics instrument called Revogene.

The mass spec-based assay can detect viral proteins eight days after the onset of symptoms, compared to four to five days with  PCR tests, its developers said.

Abbott said that the MDx platform offers a number of initial assays, including tests for HIV-1, HBV, and HCV, among others.

The partners inked a licensing deal to market and distribute TGen's DeepChek-TB as a compact, portable, and affordable diagnostic model for physician use.

Omega said that the technical file supporting its CE mark will form the basis for seeking additional regulatory approvals.

The deal will enable the Australian firm to distribute its diagnostic tests in the United Arab Emirates, Saudi Arabia, Bahrain, Qatar, and Oman.

Hardy Dx will distribute EliTechGroup's Mycofast US for detecting, enumerating, and identifying genital Mycoplasma hominis and Ureaplasma urealyticum.

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