Ortho Clinical Diagnostics researchers present data on pipeline of assays

Ortho Clinical Diagnostics is emerging stronger than ever since becoming an independent company in 2014, when it was purchased by The Carlyle Group, and has made tremendous progress in developing a range of new assays. Company researchers presented data from five assays currently under development at this year’s American Association for Clinical Chemistry (AACC) meeting.

“We are investing in our business to better serve the modern clinical lab with state-of-the-art solutions,” said Ted Farrell, Vice President Business Field Assays. “We continue to enhance the quality of our products and expand our new product development pipeline for our Clinical Laboratory business.”

The assays presented at AACC address a range of important areas for clinical lab testing including HIV detection and cardiac event monitoring. Following is a quick overview:

  • Ortho Clinical Diagnostics is developing a fourth generation assay to detect both HIV 1 antigen genotypes and HIV 1 & 2 antibody subgroups for use on its random access VITROS® systems. The assay demonstrated seroconversion sensitivity consistent with a commercially available fourth generation assay and was more sensitive than a third generation assay.
  • A rapid, fully automated, high sensitivity assay is under development for the measurement of cardiac troponin I (cTnl) and is designed to be more analytically sensitive than contemporary cTnl and cTnT assays.
  • Preliminary performance data showed that OCD’s prototype VITROS® Insulin Assay has excellent precision, cross-reactivity with pro-insulin and c-peptide as well as good correlation with two methods that are already commercially available.
  • The current VITROS® Cl- Slide is FDA cleared for use with serum and plasma, but not in urine.Testing of urine samples using the current calibration and the proper testing protocol for plasma and serum resulted in impressive performance, reproducibility and linearity.

Ortho Clinical Diagnostics is focused on bringing targeted solutions like these to its clinical laboratory customers aimed at addressing unmet clinical needs and driving improvements to quality care. It continues to press the boundaries of what’s possible in its quest for new and better assays.