consumer genomics
SNP chip data often reported by consumer genomics companies should not be considered for clinical decisions without additional validation, warn researchers.
The consumer genomics company's existing offering, called AncestryHealth, sold clinician-ordered tests that were not cleared or approved by the FDA.
While the company's new 510(k) cuts down some of the burden, consumers are still advised to consult their healthcare provider before making any changes to their treatments.
The company said the product will give customers information about their genetic risk for certain diseases.
The companies will join forces and create a new app called My Next Health, which helps gauge risk for certain conditions, including the coronavirus.
Nebula is pitching this new product as a more secure and informative alternative to mainstream consumer genomic products.
The cuts equal a 14% reduction in the consumer genomic company's workforce.
Consumers can have tests ordered by a doctor that offer insights about genetic differences and risks.
The company's platform helps patients navigate care following testing, while also offering virtual expert consultations to doctors.
The Israel-based company is offering 11 genetic risk tests, three polygenic risk tests and 15 carrier status reports.