OCDX - OCDX STOCK NEWS

Ortho Clinical Diagnostics (Nasdaq: OCDX) announced the U.S. FDA Emergency Use Authorization (EUA) for its new VITROS® Anti-SARS-CoV-2 Total N antibody test, marking the fifth assay in its COVID-19 testing portfolio. This qualitative test detects total antibodies against the COVID-19 virus, offering 99.2% specificity and excellent sensitivity. It aids clinicians in identifying past infections. Ortho's testing solutions allow labs to perform up to 150 antibody tests per hour, enhancing testing capacity across over 1,000 U.S. labs to meet ongoing community needs.

Ortho Clinical Diagnostics reported a strong financial performance for Q2 2021, with revenue increasing by 26.1% to $492.5 million. Core revenue grew 26.2% to $487.5 million, and operating income surged 104.7% to $31.3 million. Adjusted net income was $39.1 million, or $0.16 per diluted share. The company raised its fiscal 2021 guidance, expecting 10%-12% core revenue growth and 15%-17% adjusted EBITDA growth. Additionally, cash and equivalents improved to $200.9 million, while total debt decreased by 38% to $2.3 billion.

Ortho Clinical Diagnostics (Nasdaq: OCDX) has launched its semi-automated ORTHO OPTIX™ Reader in Canada, enhancing patient care for lower-volume transfusion labs. The system, compatible with the ORTHO™ Workstation, boasts 99.9% concordance with the ORTHO VISION® Analyzer. Its features include high-resolution imaging and automated interpretation, ensuring quality and standardization in lab results. This innovation allows labs to scale operations without significant investments in full automation.

Ortho Clinical Diagnostics (Nasdaq: OCDX) will release its second quarter 2021 results on August 4, 2021, after market close. A conference call is scheduled for the same day at 5:00 pm ET to discuss these results. Interested parties can access the call via the Company’s website or by phone. A replay will be available shortly after the event. Ortho Clinical Diagnostics, a leading in vitro diagnostics company, impacts over 800,000 patients daily with its innovative testing solutions, aiming to enhance patient care and laboratory efficiency.

Ortho Clinical Diagnostics (Nasdaq: OCDX) has announced the availability of its VITROS® Immunodiagnostic Products IL-6 Reagent Pack in EU countries, the U.K., and selected ASPAC and LATAM regions. This innovative assay aids in detecting and assessing inflammatory diseases, including severe respiratory infections and auto-immune disorders. The IL-6 test offers quicker inflammation detection compared to traditional methods, enhancing treatment decision-making in critical care settings. The product is supported by advanced VITROS® technologies, ensuring precise and efficient diagnostic results.

Ortho Clinical Diagnostics announced the launch of its VITROS^® Anti-SARS-CoV-2 IgG Quantitative Test, the first COVID-19 IgG antibody test to receive FDA Emergency Use Authorization. This test targets the S1 spike protein and has been calibrated to the WHO International Standard, ensuring reliable measurement of antibody responses. With 100% specificity and excellent sensitivity, the test aids clinicians and public health officials in understanding long-term antibody responses to SARS-CoV-2. Ortho’s VITROS solutions are currently installed in over 1,000 U.S. labs, processing a high volume of tests.

Ortho Clinical Diagnostics (Nasdaq: OCDX) announced a distribution agreement with Thermo Fisher Scientific™ on July 7, 2021, to deliver MAS™ Quality Controls and LabLink xL™ Quality Assurance Software through its VITROS® QC Solutions globally. This partnership aims to enhance laboratory efficiency and control through the introduction of a unique quality control solution not available elsewhere. The VITROS QC Solutions combine Ortho's quality controls with Thermo's offerings, providing real-time monitoring and improved workflows for over 800,000 patients affected daily by Ortho's tests.

Ortho Clinical Diagnostics (Nasdaq: OCDX) has introduced the ORTHO OPTIX™ Reader in the U.S. and Puerto Rico, enhancing testing capabilities for low- to mid-volume transfusion labs. This semi-automated analyzer received FDA 510k clearance on March 11, 2021, and boasts a 99.9% concordance rate compared to the ORTHO VISION® Swift Platform. The system improves operational efficiency by automating documentation and maintaining compliance with laboratory regulations, supported by Ortho Care™. This innovation expands Ortho's transfusion medicine portfolio, ensuring reliable patient care.

Ortho Clinical Diagnostics has launched the first quantitative COVID-19 IgG antibody test in the U.S., alongside a nucleocapsid antibody test. Both tests, processed on Ortho's VITROS® Systems, help distinguish antibody sources against SARS-CoV-2. The IgG test is calibrated to the WHO International Standard, providing a reliable measurement of the antibody response. The tests received Emergency Use Notification from the FDA, with the IgG test notification completed on May 19, 2021, and the nucleocapsid test on May 5, 2021.