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Ortho Adopts Startup Culture with Intense Dx Focus After Spin Off from J&J


NEW YORK (GenomeWeb) – In the more than two years since Ortho Clinical Diagnostics became independent from Johnson & Johnson, the 75-year-old Raritan, New Jersey-based diagnostics firm has been transformed into one with a startup culture and a solid focus on the Dx industry, according to the head of its North America commercial operations.

The firm's investments are paying off in an expanding product portfolio that includes the introduction of automation through an immunohematology analyzer for blood banks; the connection of multiple technologies with a broad array of assays for multiple disease areas, running on an integrated platform; an advanced HIV assay launched in Europe that's being tested for the US market; and sales and development agreements related to a biomarker-based acute kidney diagnostic test.  

"Our employees are very motivated with recent changes, and best of all, it’s cascading down into the market and to our customers," Michael Iskra, president of North America Commercial Operations of Ortho Clinical Diagnostics, told 360Dx.

"The good news," he said, "is that during the past three quarters, we have seen growth year-on-year, so we are seeing things pay off very quickly."

The Carlyle Group acquired Ortho Clinical Diagnostics from Johnson & Johnson in June 2014 for around $4 billion, launching the firm into a new era as a standalone company, according to Iskra. Ortho declined to disclose its finances, but Iskra said it is "the largest independent diagnostic company out there, and that gives us a chance to focus on the diagnostics business and not be impacted by other things."

In a reflection of investments coming to fruition, Ortho received 510(k) clearance from the US Food and Drug Administration last month that permits the sale in the US of its Ortho Vision Max automated blood analyzer for use in high-volume transfusion medicine laboratories. The analyzer is already available in Europe and Japan.

In 2015, the firm launched the Ortho Vision Analyzer, designed for small to midsized transfusion labs, and together Ortho Vision Max and the Ortho Vision Analyzer make up the firm's Ortho Vision platform.

The analyzer supports relatively complex immunohematology testing such as serial dilutions for titration studies, reflex tests, and selected cell antibody identification, according to Ortho.

Certain testing environments, including blood banks, have not realized the same kind of efficiencies that have been achieved in the core lab, Iskra said. However, pressures on a laboratory don’t just stop with immunoassays and clinical chemistry equipment.

"The Ortho Vision immunohematology analyzer for blood banks is a departure from the previous brand of automated products," Iskra said, adding the instrument is more in line with what’s seen in core laboratories. “Clearly, certain areas of diagnostics are becoming more and more automated, and Ortho Vision allows us to meet the labs' needs of being able to provide fast turnaround time and continuous access to an analyzer, which is a significant need for the blood bank."

Transfusion medicine departments are now focused not only on testing, but on connecting their work to patient outcomes, according to Ortho.

"A comprehensive portfolio of products operating on a single platform means engaging with one user interface, ordering one set of consumables, [managing] one set of processes and procedures, and streamlining training for everyone in the department," said Heidi Casaletto, head of transfusion medicine at Ortho Clinical Diagnostics. "It also means more rapid delivery of actionable results that would increase the efficiency of patient diagnosis and a recommended treatment plan."

Flexibility for the Labs

Automation is an important focus area for Ortho, Iskra said, and many of the products in its portfolio are based on that theme.

In October, the firm received FDA clearance to market its Vitros Automation Solutions in the US, along with its chemistry, immunodiagnostics, and integrated systems. Vitros Automation Solutions is integrated with the firm's 600-series of analyzers — the 3600, 4600, and 5600. It enables US clinical laboratories to improve results during each phase of diagnostic testing, according to Ortho.

The system, which is already marketed in Europe, consists of Ortho’s instruments suite with Data Innovations’ instrument management middleware and Thermo Scientific TC Automation, a system that allows laboratories to define capabilities over time for optimal efficiencies.

“Vitros Automation is a total solution for the laboratories that can provide automated preanalytic processing of patient samples, transport those samples directly to the instrument for testing, and manage the samples after testing,” Jay Snyder, head of Ortho's Clinical Laboratory Platforms and Solutions, told 360Dx. Laboratorians can, for example, automatically recap, store, refrigerate, and access an add-on test.”  

The system simplifies and automates post-analytical sample processing using an on-line storage module, which allows for up to 14,000 samples to be archived and retrieved for retesting, a critical requirement for high-volume laboratories seeking to increase productivity and reduce errors, Snyder said.

Laboratories generally retain patient samples or specimens for between two and seven days after analysis, because a physician may want to repeat or add to the original panel of tests. Being able to retrieve that original sample prevents having to obtain additional blood from the patient, Snyder added.

“If a new test is ordered on a sample that’s already in the lab and has been tested, a robotic arm goes into the refrigerator, finds that specific sample, and puts it back on Vitros automation to be routed to an appropriate instrument so that testing can be performed,” he added. “Being able to put your finger, or your robotic finger in this case, on the correct sample is a huge efficiency gain for laboratories. They’re no longer hunting for samples in a walk-in refrigerator with thousands of other samples. It’s all managed automatically for them.”

Vitros Automation Solutions is an open platform that's expandable and adaptive, and it provides laboratory clinicians with the flexibility to run and grow their labs in the manner that works best for them as needs change over time, Ortho said.

The system enables labs to connect to third-party analyzers that complement it in disciplines such as coagulation and hematology, and it enables labs to select immunoassay platforms that broaden menu coverage.

Giovanni Garozzo, director of the Transfusion Centers of ASP Ragusa, Italy, said the solution "gives us the flexibility to cope with low and high peak capacity.”

Ortho's Vitros 5600 integrated system, which connects five technologies within a system designed to remove obstacles that reduce test turnaround time, is another example of the company’s focus on providing automation for the labs, Iskra said.

According to Ortho, the system consists of more than 120 assays, covering 90 percent of the menu needs for typical labs,,across a broad range of disease areas, including infectious diseases, cardiology, thyroid disorders, metabolic disorders, oncology, and others. Its five technologies are the Vitros MicroSlide, MicroTip, MicroWell, MicroSensor, and Intellicheck Technologies.

"We have invested a lot in developing our automation capabilities," Iskra said, and while there are many definitions of automation, "for us it's a way to automate different elements of the core lab, primarily in the clinical chemistry and immunoassays. An automated track system links different testing instruments, and middleware and software connects everything."

Vitros MicroSlide Technology provides an integrated test on a thin piece of film that combines discrete spreading, masking, scavenger, and reagent layers. When plasma, serum, urine, or cerebrospinal fluid encounter these dry chemical layers, a spectral reaction occurs in separate reaction domains that can be measured by the system in the clinical chemistry lab.

The MicroTip Technology, meanwhile, utilizes single-use disposable tips and closed-reagent packs to eliminate the risk of sample carryover and reagent-to-reagent contamination, and to extend onboard reagent stability. MicroWell Technology uses a proprietary detection technology that provides immunoassay testing capabilities across multiple disease states. MicroSensor Technology detects endogenous interferences, and flags affected results without the use of reagents or extra consumables, and Intellicheck Technology monitors, verifies, and documents diagnostic checks throughout sample and assay processing for accurate and efficient result reporting.

"This is an interesting area for us because when we looked at the market, most automation was at the higher end," Iskra said. "We are seeing the same challenges of turnaround time and efficiencies of utilization of staff [in areas other than at the higher end of the market], because there’s a shortage of lab technicians and qualified individuals, and there’s not a lot of relief coming."

Iskra cited a dearth of programs generating new lab technicians as creating an unmet need for more automated diagnostic equipment.

"This is not just a big-lab problem anymore," he said. "This is also an issue with your community hospital that has staff issues and turnaround and cost pressures, and automation is proving to be a very important way to solve it."

"We're seeing more automation not only on individual platforms, but also as you move to the level of the core lab involving the connection of multiple instruments, yielding even further efficiencies," he said.

The benefit to customers is being able to fit more equipment and capability into a smaller space, such as in smaller community hospitals, Iskra said. The configuration is flexible, he added, which provides options when hospitals need to grow lab spaces or decide to move labs.

HIV and Acute Kidney Injury Diagnostics

Ortho's HIV combo immunoassay, which runs on the Vitros platform, was cleared for sale in Europe in June and is in clinical trials with a view to launch in the US toward the end of 2017, Iskra said.

Earlier this year, the firm presented initial performance capabilities of the test, which is designed to help enable early diagnosis of HIV infection and can simultaneously detect both HIV antibodies and the p24 antigen. Sensitivity to the antigen is especially useful for the very early detection of the virus.

An assessment of the clinical and technical performance of the HIV test on Vitros systems confirmed that it demonstrates seroconversion sensitivity, clinical specificity, and analytical performance comparable to the Abbott Architect Ag/Ab Combo, a commercially available fourth-generation HIV test, the firm said. Antibody detection in Ortho's test is achieved using recombinant envelope proteins for HIV-1 group M and O, and HIV-2. And p24 antigen detection is accomplished using monoclonal antibodies against HIV-1 p24.

Ortho is also developing a diagnostic test for acute kidney injury, or AKI, based on technology from Astute Medical. The test, a single-use cartridge, identifies two biomarkers — TIMP-2 and IGFBP-7 — and enables clinicians to assess critically ill patients for the risk of moderate to severe injury within around 20 minutes. The biomarkers are involved in G1 cell cycle arrest during the very early phases of cellular stress, and are, therefore, robust measures of moderate-to-severe risk for AKI, manifesting within 12 to 24 hours, Ortho said.

According to Iskra, AKI rarely comes up at the top of a hospital’s service line, "but if you go down to item No. 3 to 11, AKI is there. It’s one of the most costly and deadly conditions and has a high level of impact on the quality of life of a patient.

“We see an opportunity to add a lot of value for the labs and help hospitals change the way that [they] care for the patient," he said.

Astute Medical has granted Ortho Clinical Diagnostics a semi-exclusive worldwide license to develop and commercialize a version of the test for use on its Vitros line of testing platforms. Its commercialization is pending regulatory approval. And Ortho is the exclusive sales agent for the Astute Medical NephroCheck test in the United States and in certain countries in Europe.

The product portfolio reflects important strategic investments by the Ortho clinical management team over the past couple of years since the spin off to Carlyle. "The new management team got the organization focused on what matters most and set some priorities," Iskra said.

The firm has added 1,300 employees overall since being acquired by Carlyle. “If you look at the diagnostics business, that’s a big number,” he said, adding in the US, Ortho has created 100 new positions, most of which provide greater support and coverage to its customers.

The July Fourth weekend this year was Ortho's Independence Day, because in the US, Europe, and a few other regions, the firm completely separated from Johnson & Johnson, he said.

"That was a big milestone for us. It is also in line with a big inflection point in our business, where we are looking past initial investments and expecting to see them take root and start to see a return."