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Quest acquires PhenoPath

November 2018—Quest Diagnostics has acquired PhenoPath Laboratories, which provides immunophenotyping, hematopathology, and molecular pathology services. The PhenoPath business, in Seattle, will operate as part of AmeriPath, a wholly owned business of Quest.

Steve Rusckowski, Quest chairman, president, and CEO, said in a statement: “PhenoPath has a strong record of innovation and provides several capabilities that complement and extend our own, particularly in pathology and molecular oncology. It also deepens our presence in the Pacific Northwest.”

Dr. Gown

PhenoPath founder Allen Gown, MD, tells CAP TODAY that continued consolidation in the laboratory industry and insurance reimbursement challenges have posed significant risks to PhenoPath’s future growth. “In Quest/AmeriPath,” he says, “we found an organization that realized not only the excellence of PhenoPath’s past and present but also the extraordinary future that, with their assistance, we can have.” Dr. Gown founded PhenoPath in 1998.

Quest understands PhenoPath’s anatomic pathology, hematopathology, and molecular oncology strengths and track record of innovation, Dr. Gown says, both of which can enhance the capabilities of Quest’s national network “while it continues to serve PhenoPath’s loyal clients nationwide.”

Abbott introduces next generation of influenza, strep A assays

The FDA cleared Abbott’s next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing. Both assays are available on the ID Now platform (formerly Alere) and have been granted a CLIA certificate of waiver.

The enhanced Influenza A & B 2 assay offers molecular detection and differentiation in 13 minutes or less, Abbott says, with early call out of positive results in as little as five minutes. It allows for room temperature storage of test components.

The Strep A 2 provides molecular detection of Group A Streptococcus bacterial nucleic acid in six minutes or less, with call out of positive results as early as two minutes, according to Abbott, with no culture confirmation required for negative results.

NeoGenomics to acquire Genoptix

NeoGenomics has entered into a definitive agreement to acquire Genoptix for $125 million in cash and 1 million shares of NeoGenomics common stock.

In announcing the agreement, NeoGenomics said it would advance its expansion into community oncology practices, noting that oncology practices are an “important, and under-penetrated, channel for promoting NeoGenomics’ capabilities in next-generation sequencing and liquid biopsy.”

FDA OKs emicizumab-kxwh for hemophilia A with or without FVIII inhibitors

The FDA in October approved emicizumab-kxwh injection (Hemlibra, Genentech) for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A with or without factor VIII inhibitors.

Hemlibra was first approved in 2017 for patients with hemophilia A with FVIII inhibitors. (See “Hemophilia drug interferes with APTT-based assays,” CAP TODAY, September 2018.)

The latest approval was based on the HAVEN 3 and HAVEN 4 clinical trials. It expanded the indication for patients with hemophilia A without factor VIII inhibitors and provided for new dosing regimens for patients with and without factor VIII inhibitors.

Leica launches integrated specimen containment and transport system

Leica Biosystems in October launched MammoPort, an integrated specimen containment and transport system for breast tissue biopsies.

“By standardizing the process of transferring breast biopsy tissue from the radiology suite to the pathology lab, MammoPort maintains the quality of core specimens,” Peter Reimer, vice president of core histology at Leica Biosystems, said in a statement. MammoPort eliminates the need for manual tissue handling by radiology technologists, according to the company.

Illumina launches TSO 500

Illumina launched TruSight Oncology 500, a pan-cancer assay designed to identify known and emerging tumor biomarkers.

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