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Beckman Coulter's De Novo Clearance Signals New Initiatives in Clinical Flow Systems

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NEW YORK (360Dx) – The US Food and Drug Administration recently cleared Beckman Coulter's ClearLLab reagents through the de novo process, giving laboratorians access, for the first time, to approved antibody cocktails that aid in the immunophenotyping and detection of certain leukemias and lymphomas.

The clearance of ClearLLab reagents, according to diagnostic industry experts, may have a noteworthy impact for clinicians testing for leukemias and lymphomas.  

The ClearLLab reagents, which run on Beckman Coulter's FC 500 one-laser, five-color flow cytometer, is performed on blood, bone marrow, or lymph nodes in patients with chronic and acute leukemia, lymphoma, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.

Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement that the clearance of ClearLLab reagents is a noteworthy advance for clinicians. It "represents a major step forward for the hematology-oncology community," he said, adding that as a result of the clearance, laboratories and healthcare professionals "now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers.”

Flow cytometry has become a critical component in pathologic classification of both lymphoid and myeloid malignancies, Gwen Nichols, chief medical officer of the Leukemia & Lymphoma Society, said in an interview.

"As we are in the midst of an era of expanded treatment options for patients with hematologic malignancies, accuracy of diagnosis becomes increasingly important," Nichols said, adding that "Missing a critical reagent in a flow cytometry panel can make the difference between a patient getting the appropriate treatment, or following a regimen which will not effectively treat their disease."

The ClearLLab clearance does not represent new antibodies or targets, Nichols noted, but "the clinically validated premixed reagents eliminate some of the error inherent in current manual antibody cocktail preparation."

Nichols said that although the ClearLLab test results cannot alone diagnose hematologic malignancy, "consistent and reproducible flow cytometry results are a key component of accurate diagnosis, an issue of critical importance" for patients.

She added that consistent testing of surface markers that follow international guidelines will allow for increased standardization across sites and protocols.

Julie Downsborough, a Beckman Coulter Life Sciences spokesperson, said in an interview that "The availability of the reagents in the US means clinical laboratories no longer have to develop their own laboratory-developed tests," in these applications.

Apart from the recent clearances and launches, additional flow cytometry product launches from Beckman Coulter are expected in the near-term, she said.

The clearance enabled marketing in the US of one of three new products that the firm had recently developed here for clinical flow cytometry applications.

The new products expand the portfolio of clinical solutions that are offered by Danaher's diagnostic companies Cepheid, Leica Biosystems, Radiometer, and Sciex Diagnostics, as well as Beckman Coulter.

The launches also come amid a major change in Beckman Coulter's diagnostics plans and investor unrest in the firm.

The diagostics business of Life Sciences business unit of Beckman Coulter recently stopped the sales and development of Veris, a molecular diagnostics platform for high volume laboratories launched in Europe in 2014 that had been in development since 2008

Cowen analyst Doug Schenkel wrote in a research note earlier this month that "Danaher has made clear progress over the last several years with Beckman, but many are hoping for an acceleration in growth that exceeds current [Wall Street analyst] estimates."

He noted that in meeting with Danaher at the American Association of Clinical Chemstry's annual meeting this month, "we have heard management indicate that Beckman is a 'battleship,' … meaning, changing the trajectory at Beckman takes time."

However, he said that the investment bank received an update from Danaher consistent with its view that "Beckman growth is poised for continued improvement via new product launches and menu expansion."

At AACC, Beckman Coulter said that it is developing "a new and advanced range of clinical flow systems to be launched over the next five years."

In addition to the ClearLLab reagents clearance, in June, Beckman Coulter Life Sciences received 510(k) clearance for its Navios EX flow cytometer immunoassay, which uses identification and counting to reveal biological and physical properties of cells and other particles. In combination with Beckman Coulter's Tetra reagents and system software, the immunoassay provides automated analysis of lymphocyte subpopulations, the firm said.

Through its ruling, the FDA cleared a modification to Beckman Coulter's existing Navios flow cytometer. The new system incorporates advanced optics and laser technology that are part of the firm's CytoFlex flow cytometer used in life science research applications.

Also in the second quarter of this year, Beckman Coulter Life Sciences expanded the workflow capabilities of its Aquios CL Flow Cytometry System, an instrument used for central laboratory-based HIV and T-cell based infection testing. The firm achieved this through the addition of Aquios designer software developed specifically to handle user-defined tests in the routine lab.

The software and flow cytometry system take aim at issues related to sample preparation and data management that tend to present bottlenecks in routine flow cytometry. Even with a semi-automated process, laboratorians might spend hundreds of hours per year for tasks that take away from a lab's productivity, Beckman Coulter said.

The firm noted that it's Aquios CL Flow Cytometry System streamlines operations by incorporating automated loading, sample preparation, reagent management, barcode scanning, data analysis, and bidirectional laboratory information system connectivity.

The software also opens up the instrument to be able to run laboratory-developed tests, Downsborough said.

When laboratories want to run LDTs, they order reagents from Beckman Coulter that are applied to the Aquios system, and the system takes care of all the reagent handling, including cocktailing, which frees up lab staff time, Downsborough noted.

For labs with high staff turnover, the test is advantageous, Downsborough said. A healthcare worker can be trained on the use of the instrument within an hour, and they can then proceed to train their lab staff.