The firm said that its Verigene II multiplex system is on track to launch in mid-2020 among a number of new products scheduled for release this year.
The company will use the money to acquire PCR equipment to be used in connection with sales of reagents for infectious disease tests, among other uses.
The firm reported that test volumes for its Cologuard colorectal cancer screening test rose 63 percent year over year.
The bipartisan bill is backed by more than 250 organizations, but ACMG remains opposed, arguing that ordering tests is part of the practice of medicine.
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.
The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.
The new Series B investment was made by Northpond Ventures, with previously invested $20 million in the Australian diagnostics company.
The firm submitted its Verigene II Gastrointestinal Flex Assay to the FDA in Q4 and expects to submit Verigene II Respiratory Flex Assay to the agency in Q1 2020.
Initially, FIND and the WHO will work to develop national essential diagnostics lists, as well as to collect data to support countries in their aim to provide universal health coverage.
PacBio will try to take the Sequel II to the clinic in China with the help of Berry Genomics and is open to partnerships globally, including with Illumina.
Sienna will provide sales, marketing, and technical support training to Immuno Diagnostics staff, as well as establish a reference lab.
The South Korean company has now received CE marking for its hepatitis B, hepatitis C, and HIV-1 detection kits, which run on its ExiStation system.
Diagnostics segment revenues for the company fell 5 percent to $38.4 million, and life sciences revenues dropped 15 percent to $12.6 million.
The company attributed its revenue shortfall to billing issues in the prenatal testing business and announced that CFO Bryan Riggsbee will be interim CEO.
The company announced the launch of the new products in the US and Europe as part of a product portfolio it has named Panther Scalable Solutions.
The company expects that Blueprint's informatics capabilities in particular will improve variant interpretation and reporting across all its genetic test offerings.
The companies will use ProSciento's Nash Pass patient registry and Nordic Bioscience's biomarker technology to validate the translational biomarkers.
The company said the financing brings it a step closer to fulfilling its vision of enabling new-generation tissue analytics tests based on its microfluidic technology.
The firm is lowering its guidance due to anticipated revenue loss related to remediation efforts associated with its Alaris pump system.
The deal with Quaphaco includes minimum Unyvero A50 instrument and infectious disease test cartridge purchases of €1.9 million over the initial three-year term.