The DOJ alleged Biotheranosics promoted and performed its Breast Cancer Index test for patients who had not been in remission for five years and who had not been taking tamoxifen.
The approval expands the firm's product range now available to European customers.
PartoSure includes a noninvasive strip test that detects placental alpha microglobulin in patients and is already being used in 35 countries in Europe, the Middle East, Asia, and Latin America.
The workflow was launched along with a menu of infectious disease detection kits, including assays for cytomegalovirus, Epstein-Barr virus, BK virus, and parvovirus.
The company anticipates that the negative impact of PAMA will be offset by an estimated $180 million in tax savings due to tax reform.
The partnership will allow Serosep's customers to benefit from standardized diagnostic interpretation supported by artificial intelligence and automation.
Amplidiag CarbaR+MCR detects the main carbapenemase-producing organisms and colistin resistance markers. Novidiag Bacterial GE+ identifies the most common enteric pathogens.
Sales were driven by a strong flu season and growth in Asia-Pacific business.
The company's Diagnostics business was up 14 percent, while its Life Sciences business grew 13 percent. The firm also closed its $2 billion buy of IDT last week.
The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.
The test cartridge runs on the company's Unyvero platform and covers 103 diagnostic targets for various pathogens and markers of antibiotic resistance.
The ResistancePlus MG Positive Control kit was listed with the FDA for sale in the US, where it will be sold through SpeeDx's US entity.
MedTek21's software is designed to continuously analyze patient records to provide real-time personalized medication reports to physicians.
The firm said that its system combines many of the analytical strengths of a higher-volume instrument with the ease of a table-top analyzer.
The firm said that it expects to log $500 million in revenues from its Alere rapid diagnostics business in the second quarter.
Isoma, which launched last year, will use the funds to develop and clinically validate a molecular test for stratifying glioblastoma patients.
The test will expand the range of diagnostic options available to guide treatment of Plasmodium vivax malaria, which relapses.
Miami-based Nicklaus will send patient blood samples to Rady Children's in San Diego for WGS, bioinformatics analysis, and initial clinical interpretation.
The firms will work to accelerate the adoption of PierianDx's genomics platform for translating data into patient-specific diagnoses and treatments.
In developing the new tools, Google trained artificial intelligence algorithms to aid pathologists in making breast and prostate cancer diagnoses.
The company will use the funding to advance the commercialization of its proprietary liquid biopsy technology.
The firm said that its Cobas CT/NG real-time PCR assay is the first available in the US for the testing of sexually transmitted infections on its 6800 and 8800 systems.
The companies plan to commercialize MIODx's immune sequencing technology for diagnostic purposes.
The test is designed to identify a tumor's tissue of origin by assessing 2,000 individual genes and covers 15 common tumor types.