Renee Balliet, PhD, Product Manager, Genetic Solutions

Recent Posts

FDA Announces New Premarket Notification Exemptions

On July 11, 2017, the FDA announced Exemptions from Premarket Notification: Class II Devices. The list, which includes more than 1,000 class II devices, includes genomic platforms and tools:

  • High-throughput DNA sequence analyzer
  • DNA genetic analyzer
  • Mass spectrometer for clinical multiplex test systems
  • Real-time nucleic acid amplification system
  • Complete gene expression profiling accessory reagents
  • Quality control DNA materials 

 So what does this mean for genetic tests?

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Topics: Hayes Blog, Genetic Testing

Approaches to Genetic Testing: Somatic vs Germline

Not all genetic tests are created equal. It’s a fact that applies not only to quality, but also to the information that the test reveals. Therefore, it is important to ask: should all genetic tests be assessed the same way? The answer is not a simple “yes” or “no,” but rather the question demands a closer look at the types of variants (changes in the DNA or other biomarkers) the test is assessing. This week, we will highlight the key differences between germline and somatic variants and the implications for tests that examine each.

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Topics: Hayes Blog, Genetic Testing, Health Technology Assessments,

Leading the Way: Giving Genetic Testing Context

There are more than 65,000 genetic tests available on the market today and new genetic tests are added daily. According to the website GeneTests.org, there are currently more than 650 laboratories manufacturing tests for more than 4,500 disorders. The quick math? There are potentially thousands of different tests for a clinical indication. But how do payers and providers even begin to identify when genetic testing can be useful, let alone which test to use? 

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