clinical utility

At a Thermo Fisher-sponsored workshop, two companies argued for the clinical utility of PGx LDTs as FDA prepared to issue a warning against unapproved tests.

The company has two clinical utility studies underway and one large clinical validity study slated for publication later this year.

An analysis has found that the odds of getting a diagnosis through WES or WGS is 8.3 times greater than it is through chromosomal microarrays.

The projects, organized by Friends of Cancer Research in the US and the Quality Assurance Initiative Pathology (QuIP) in Germany, are comparing different TMB assays.

While a randomized-controlled trial is underway, Genomind hopes data from a new case-control study will convince insurers its PGx test can reduce healthcare utilization costs.

Under a collaboration with GeneDx, Boston Children's has rapidly sequenced the exomes of 20 NICU babies and have arrived at a likely diagnosis in around 85 percent.

Using a blood volume of 100 μL, the test demonstrated a sensitivity of 90.2 percent for the diagnosis of blood-culture positive sepsis episodes.

The study, launched today, aims to evaluate the use of liquid biopsy and natural killer cell testing for the early detection of recurrent breast cancer.

Results of a new study show that patients guided to targeted therapy based on ctDNA get the same benefits as those who got tissue-based tests in initial clinical trials.

Caris Life Sciences also found that time-to-next treatment could be a surrogate endpoint for survival.

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