Put It on the Board, 12/17

Sysmex offers two new hematology systems

Sysmex America introduced last month two hematology automation systems, the XN-9100 and XN-3100. Both systems integrate with the new SP-50 fifth-generation slidemaker-stainer.

The XN-9100 saves space over previous models with its new twin modularity, combining two neighboring XN units in one twin module. It offers enhanced adaptability with add-on modules for lab-specific modification to meet testing needs, including total lab automation connectivity that is compatible with major manufacturers’ systems.

The XN-3100 is a compact benchtop unit for lower- to mid-volume testing facilities. The recommended workload is 250 to 400 samples per day.

Sysmex announced on Nov. 8 that its XW-100 CBC analyzer received FDA clearance, making it the first CLIA-waived CBC system.

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FDA approves Ventana ALK (D5F3) CDx assay

Roche has obtained FDA approval for the Ventana ALK (D5F3) CDx assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer patients eligible for treatment with Roche’s Alecensa (alectinib). The Ventana ALK (D5F3) CDx assay is the only test approved as a companion diagnostic for Alecensa.

The assay is intended for the qualitative detection of the anaplastic lymphoma kinase protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma tissue stained with a BenchMark XT or BenchMark Ultra automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with Xalkori (crizotinib), Zykadia (ceritinib), or Alecensa.

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Study: Fewer biopsies for men tested with phi

A study published in Prostate Cancer and Prostatic Diseases found that physicians elected to perform fewer biopsies when Prostate Health Index, or phi, testing was included in their overall routine clinical assessment.

Phi testing is for men presenting with elevated serum total PSA in the 4–10 ng/mL range and a non-suspicious digital rectal exam. The findings, published in the November online issue of the journal (doi:10.1038/s41391-017-0008-7), were based on a comparison of more than 500 men tested with phi to a historical control group of similar men seen by the same participating urologists within the previous 24 months, and prior to the commercial implementation of phi testing in their practice. The FDA-approved test is exclusive to Beckman Coulter.

According to the study, titled “Clinical utility of the Prostate Health Index (phi) for biopsy decision management in a large group urology practice setting,” men receiving a phi test showed nearly a 24 percent reduction in biopsy procedures performed compared with the historical control group (36.4 percent versus 60.3 percent respectively, P<0.0001). Physicians reported that the phi score had a significant impact on their patient management plan in more than 73 percent of cases, including biopsy deferrals when the phi score was low, and decisions to perform biopsies when the phi score indicated an intermediate or high probability of prostate cancer (phi≥36).

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ArcherDx, Celgene sign CDx agreement

ArcherDx has signed an agreement to develop and commercialize a next-generation-sequencing-based oncology companion diagnostic for Celgene’s investigational drug CC-122 for indications in diffuse large B-cell lymphoma.

Under the terms of the agreement, ArcherDx will use its Anchored Multiplex PCR technology combined with the Illumina MiSeqDx sequencing system and Archer Analysis bioinformatics software to develop the companion diagnostic. The assay is based on a proprietary gene expression signature developed by Celgene to identify DLBCL patients most likely to respond to CC-122, a cereblon-modulating agent currently under investigation in multiple disease settings.
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