The test, the fourth Zika serological assay available under EUA, qualitatively detects Zika virus IgM antibodies in human serum and plasma.
The company's Hong Kong laboratory was established in 2010 and was accredited by the College of American Pathologists in 2013.
The firm plans to launch its first test from the lab, a mRNA-based noninvasive confirmatory lung diagnostic, by the end of this year.
The deal includes mainly Siemens' customer's sales and distribution contracts, the installed instrument base, and relevant intellectual property.
The company combines screening of live, patient-derived tumor cells with DNA sequencing and data analysis to match individuals with optimal drug therapies.
The assay was cleared and CLIA-waived for use on Quidel's Sofia 2 instrument for the detection of RSV using nasopharyngeal swab and nasopharyngeal aspirate/wash specimens.
The company's reference lab in Marseille, France can now receive patient samples from certain states in the US for testing with the Immunoscore Colon test.
With the new certification in hand, the company plans to expand its business in the US through its Pennsylvania-based subsidiary, B. Braun CeGaT.
Entering a new chapter with a new leader, ACLA lends support to a draft bill that would regulate lab tests not as medical devices but as in vitro clinical tests.
The firm noted that the receipt of a CLIA waiver markedly expands the available market for use of the Sofia 2 system in detecting influenza types A and B.