NEW YORK (GenomeWeb News) – Lumigenix has launched what it said is the first personal genomics testing service provided directly to consumers in Australia.
The private California firm, which is owned by an Australian parent, has launched a saliva sample testing kit that provides information about predisposition to common diseases, traits such as caffeine metabolism and taste perception, and ancestry information based on haplogroups.
According to the company's website, the introductory test kit is currently being marketed at a US$99 sale price that is marked down from a regular price of $279.
The Lumigenix genotyping services are conducted through partnerships with Illumina and the Australian Genome Research Facility, and its service includes a risk report based on peer-reviewed content from Mayo Clinic.
The company said that its tests are for 76 risks for common diseases that can be caused by gene-environment interaction, and that it is intended to provide consumers with information that can motivate them to make changes to minimize their risks or increase health.
Lumigenix also said that it will not provide results for carrier status for diseases, such as BRCA mutation status for breast cancer, but it plans to launch in the future a separate product for such tests that will incorporate physician and geneticist review.
A company official acknowledged in an e-mail to GenomeWeb Daily News that the firm is launching in an unclear regulatory environment, as the direct-to-consumer genomics field has come under scrutiny from the US Food and Drug Administration and may become subject to regulation by that agency. The official added that Lumigenix believes it is currently operating in accordance with Australia's laws.
The company said during its launch that it believes that developing standards for the industry, instead of banning DTC tests, would be the best regulatory approach for governments to pursue.
"We believe people are both capable of understanding, and should have access to, their own genetic information," Lumigenix CEO Romain Bonjean said in a statement announcing the launch. "We consider our responsible approach to be one that the Australian health and medical community will start to embrace, as we are not trying to replace their expertise, but to arm interested people with additional information."
"In the near future we also hope to develop relationships with research bodies to allow our customers to anonymously provide their data to advance Australian genetic research," he added. "Therefore, we consider a one-size-fits-all regulatory approach ineffective for such a complex industry."