At-Home Microbiology Tests Trigger Concerns about Scientific Value and Impact from Microbiologists and Clinical Laboratory Scientists

As science learns more about the human genome, new companies are being formed to offer consumers at-home microbiology test kits, a development many microbiologists consider worrisome Can consumers rely on the accuracy of at-home microbiology tests that promise to give them useful information about their microbiome? That’s just one question being asked by clinical laboratory scientists and microbiologists in response to the proliferation of companies offering such tests. Advances in gene...

Patent Dispute over CRISPR Gene-Editing Technology May Determine Who Will Be Paid Licensing Royalties by Medical Laboratories

U.S. Patent and Trademark Office will hold hearings to determine whether University of California Berkeley, or Broad Institute of Harvard and MIT, should receive patents for new genomic engineering technique In the race to master gene-editing in ways that will advance genetic medicine and patient care, one of the hottest technologies is CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats. But now a patent fight has the potential to complicate how pathologists and...

23andMe Submits Genetic Test Applications with the FDA

23andMe executives want the credibility that FDA clearance provides for its DNA tests and declared their intent to eventually support more clinical laboratory test applications Offering genetic tests directly to consumers is a controversial subject among some pathologists and healthcare ethics experts, who question both the science of these tests and whether consumers will do the right thing with the information. Now that debate is likely to heat up, because direct-to-consumer genetic testing...
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