In June, the FDA cleared tests for a broad range of conditions, including Group B strep, systemic rheumatic disease, and chlamydial or gonococcal urogenital disease.
The trial, part of a multiyear effort to standardize HbA1c testing in labs, will be repeated annually with more labs participating and more countries represented.
Bio-Rad tallied net sales of $551.5 million compared to $500.1 million in Q1 2017, driven by growth in both its Life Science and Clinical Diagnostics businesses.
As previously disclosed, Bio-Rad's accounting firm needs more time to complete its audit and the company plans to file the form as soon as possible.
The firm offers a high-throughput, automated and a low-throughput, manual solution and now plans to address mid-range needs with two new instruments.
The firm saw an increase in sales for both the life science and clinical diagnostics segments.
Bio-Rad received 510(k) clearance for its IH-Incubator L and IH-Centrifuge L instruments for use with the company's full range of IH-System Gel Reagents.
The firm has provided glimpses into its strategies for developing a line of regulated droplet digital PCR tests in a number of recent forums.
Among the diagnostic firms presenting at the conference on Tuesday were lab giant LabCorp, diversified medical products firm Hologic, and MDx startups, such as Adaptive Biotechnologies.
The stock prices of 17 of the 25 firms in the 360Dx Index fell month over month with Enzo Biochem and Bio-Rad leading decliners.