Cancer tests dominate AMP 2019 | FDA renews warning on biotin interference | Cervical cancer testing at home

Dear LabPulse Member,

The Association for Molecular Pathology (AMP) annual meeting has come and gone. Held November 7-9 in Baltimore, the meeting featured numerous product launches and workshops by the leading IVD vendors.

We featured coverage from the meeting by Bruce Carlson, publisher of market research company Kalorama Information, a sister company of Carlson was on the ground in Baltimore, visiting vendor booths and taking stock of key trends.

There was a strong focus at the meeting on advances in oncology, including innovations for enabling faster cancer detection and the direction of patients to the appropriate treatments based on their genetic profiles. Sequencing giant Illumina introduced TruSight Oncology 500 ctDNA -- the company's first liquid biopsy solution for cancer -- which is designed for comprehensive genomic profiling on the company's NovaSeq 6000 sequencing system. Illumina also promoted a high-throughput version of TruSight Oncology 500 for genomic profiling of tissue samples. Both are research-use-only products and will become available in early 2020, according to the company.

Another product news highlight at AMP 2019 was Promega's announcement of a global collaboration with Merck to develop a companion diagnostic for microsatellite instability status in solid tumors. The test will be used to guide treatment with Merck's checkpoint immunotherapy pembrolizumab (Keytruda).

In regulatory news, we featured a breaking news alert on an updated safety communication from the U.S. Food and Drug Administration (FDA) on managing the risk of biotin interference. The FDA felt it was necessary to update a 2017 safety communication about biotin interference in lab tests -- particularly when it comes to troponin assays used to evaluate cardiovascular status. Patients may not even be aware of how much biotin they are getting through supplements, such as hair and nail strengthening products. As part of the update, the agency published a list of tests from vendors it feels have not done enough to minimize the risk of interference and incorrect results.

On the clinical front, researchers have been documenting the lay of the land for cervical cancer screening, and they are investigating ways to boost uptake. Cervical cancer is preventable, but access to screening is paramount for early detection. Researchers at the University of Michigan advised that attention is often drawn toward young girls and women, with the goal of preventing cancer-causing HPV through vaccines and HPV testing, but half of cervical cancer cases are diagnosed in women older than 49. And for this demographic, there is a lot of room for improvement based on survey data, the researchers reported in Preventive Medicine.

Separately, a large study by Kaiser Permanente Washington looked into the use of home self-testing for HPV as a means of boosting cervical cancer screening participation rates. The study did show a significantly improved rate of screening thanks to home testing, but it was a modest difference, and practical challenges remain. Meanwhile, researchers in the U.K. shared experience with their investigational DNA methylation panel for evaluating vaginal and urine samples taken at home. The panel is as sensitive as standard HPV testing, but it has better specificity for high-risk findings, according to the group.

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