A draft bill provides for a major expansion of eligible material, a move the ACLU and AMP said threatens to reduce competition in genetic testing.
Proceeds from the loan facility will go toward the acquisition of Envigo's nonclinical research services business and other general corporate purposes.
The broader market drove down the stock prices of many diagnostics companies. Natera, Guardant Health, and CareDx paced the gainers.
In a regulatory filing, Quest said that the system stored credit card numbers, and bank account, medical, and social security information.
Dubbed Automobi Molecular Diagnostics, the company will establish local manufacturing facilities and work to commercialize the Novodiag platform in China.
The agreement is part of Biocartis' long term plans to expand its presence in the oncology field by building a menu of tests for immunotherapies.
The company drew $49 from the credit facility to repay an earlier outstanding loan and expects to draw another $27 million to, in part, pay for its acquisition of GenePOC.
The firm plans to use proceeds to fund commercial activities related to its ClonoSeq assay, as well as research into drug discovery and its project to map TCR antigens.
The assay is for detecting varicella-zoster virus in cerebrospinal fluid and can be used with the firm's Liaison MDx instrument.
Caris will use its whole-transcriptome sequencing assay and Molecular Intelligence Trials service to identify patients for a phase II clinical trial.
The company is commercializing a method developed by researchers at Johns Hopkins that detects cancer with high specificity from a blood sample.
The digital pathology system can be used for primary diagnosis as a result of the 510(k) clearance, which followed a multicenter study conducted at five clinical sites.
The immunoassays are are indicated for the quantitative determination of IgM RF antibodies and the semi-quantitative determination of IgA RF antibodies.
Invitae will perform genetic testing using a 58-gene panel and Horizon will provide financial support for the program aimed at improving diagnosis of the rare condition.
The Aptima BV test detects bacterial vaginosis and the Aptima CV/TV detects and differentiates candida infections from trichomonas.
The companies will work together first to develop a companion diagnostic for Bayer's TRK inhibitor larotrectinib, with opportunities to expand to other drugs and drug candidates thereafter.
The resulting company will retain the Lumos name and focus on the international launch of RPS' FebriDx test for febrile acute respiratory infections.
The test, called ColoPlex and being developed using the xMAP technology, is a blood test that uses multiplexed immunoassay technology and machine learning.
Product sales from OEM customers were up 28 percent, while product sales from direct customers and distributors increased 27 percent, and other revenues grew sharply.
The self-administered test is designed to detect human chorionic gonadotropin levels in women as early as six days before a first missed period.