New recommendations for CYP2C9 testing | Biomarker emerges in prostate cancer | T2 Biosystems reports data for bacteria panel

Dear LabPulse Member,

It's an exciting time to be covering developments for this new website for clinical laboratory professionals, with much progress already made toward the goal of precision medicine -- but so much work still to be done in making targeted treatment a reality for most patients.

A study published last week by researchers at the University of Toronto and Stanford University in JAMA Psychiatry highlighted the challenges in bringing a precision approach to the treatment of mental health disorders. The investigators explored the role of C-reactive protein as an inflammatory biomarker for bipolar disorder in a prospective study, but they found that it was not useful for guiding treatment with the anti-tumor necrosis factor antibody infliximab. An editorial about the study commented that precision medicine is much hyped but remains an elusive goal in psychiatric disorders.

In contrast with psychiatry, oncology has proved to be a successful testing ground for biomarkers and personalized medicine approaches. Researchers at Yale reported the discovery of a new biomarker, syntaphilin, in the American Journal of Pathology. The mitochondrial protein could be helpful in identifying men with more aggressive prostate cancer and targeting treatment accordingly, the group concluded.

This is a big week in the world of cancer treatment, as the abstracts for the American Society of Clinical Oncology annual meeting are slated for release on May 15 at 5 p.m. EST, ahead of the event, which is taking place May 31 through June 4 in Chicago. On May 13, Grail announced that it will present data for its blood test for detecting multiple cancers at the meeting. The company noted that it has selected DNA methylation as its next-generation sequencing method of choice for the assay, which is designed for the early detection of cancers and identification of the origin of tumors. The assay has the breakthrough device designation from the U.S. Food and Drug Administration (FDA).

Genetic testing for CYP2C9 alleles and variants is an important part of practice when prescribing a broad range of medications, including the anticoagulant warfarin, to ensure that patients can metabolize the treatment. However, the number and type of alleles tested vary a lot in the U.S. depending on the laboratory, and alleles important for people with African ancestry may be left out, which creates a risk for adverse events. In light of these shortcomings, the Association for Molecular Pathology and the College of American Pathologists released new recommendations on May 7 spelling out what should be included in CYP2C9 lab tests and suggesting some optional alleles to test for.

In recent product news, T2 Biosystems published data from a multicenter study validating its T2Bacteria panel, which screens blood directly for five common kinds of bacteria that cause bloodstream infections: Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Escherichia coli. The accuracy of the test, which was approved by the FDA in May 2018, is similar to that of blood cultures but with much faster turnaround of results. However, it's unclear how the test would fit in hospitals' workflow and whether there will be a demand for data showing a clear benefit for patient outcomes.

In addition to reporting research and product news, brings you practical coverage of new technologies that are being implemented in laboratories. Contributing writer Joseph Constance reported on the adoption of digital pathology systems by smaller labs, following the approval of the first digital pathology system for diagnostic use in the U.S. in 2017. The cost of systems has been a barrier to adoption, but the transition to digital pathology is inevitable, and small to midsize labs have the option of scaling up gradually to ease the financial burden, Constance reported.

Going forward, we plan to bring you more stories that will help you manage your lab better and assist with the implementation of new technologies. As always, the door is open for you to suggest ideas for coverage in or to contribute your own articles for publication. Don't hesitate to get in touch.

Page 1 of 4
Next Page