NEW YORK (GenomeWeb) – Dante Labs, a startup with offices in Italy and New York, recently began offering a handful of sequencing-based genetic tests, including hereditary cancer and cardiovascular disease risk assessment tests, directly to consumers in Europe.
The firm, which outsources both testing and bioinformatics analysis to a number of partner laboratories, wants "to empower people with knowledge and insights about their own genetic information so that they can live healthy, long and happy lives," according to its website. Later this year, Dante Labs plans to expand its assay menu and to start offering tests in Asia and the US.
Last month, the company launched six genetic tests in Europe: a whole-genome sequencing test for €850 ($955), a whole-exome sequencing test for €530 ($590), a hereditary cancer test covering 27 genes for €469 ($530), a BRCA1/2 test for €349 ($390), a cardiovascular disease risk test covering 31 genes for €469 ($390), and a cystic fibrosis test of the CFTR gene for €299 ($335). Customers can order the tests from the company's website, and, since earlier this month, through Amazon UK.
While Dante Labs stresses that it is compliant with legislation that protects customers' data privacy and security, it does not require a healthcare professional — a doctor prescribing the test or a genetic counselor providing pre- and post-test counseling — to be involved. Hence, the company cannot offer its tests in certain European countries that stringently regulate genetic testing.
Many experts maintain that medical supervision should be mandatory for health-related genetic tests in order to protect individuals from receiving inappropriate information.
Dante Labs was founded late last year by Andrea Riposati, a former senior product manager at Amazon and the firm's CEO, and Mattia Capulli, an assistant professor at the University of L'Aquila in Italy who has a background in biotechnology. The two had known each other from high school and decided to form the company after meeting again.
Their aim is to make genetic testing available to individuals online at low prices, and to cut out any middlemen — including doctors — while providing high-quality analyses from established genetic laboratories that don't sell their tests to individuals directly.
Riposati said that in Italy, for example, BRCA1/2 testing is currently only available to individuals with at least three family members affected by cancer. "Even if you are willing to pay for a BRCA1/2 test, you can't get one," he said. "You have to wait for a third person in your family to get sick. This is unfair. We are trying to fix this."
Offering tests directly online helps save overall costs. "Today, individuals have to pay a fee and they don't know how much of that they have to give to the doctor, how much to the lab, how much to another company," he said.
While the concept is not new — companies like Color, Veritas, and Counsyl already sell various types of genetic tests online in the US, though they all require authorization by a doctor — Dante Labs wants to offer a large number of assays and provide them on a global scale.
The company, which currently has five employees, obtained less than $500,000 in seed funding last year, Riposati said, and plans to raise on the order of $1 million from additional angel investors and venture capital firms later this year.
At the moment, Dante's tests are available across Europe, he said, except in Germany, Switzerland, and the Netherlands, where the company is not allowed to sell them.
This summer, Dante also plans to launch tests in South Korea, Japan, and China, and by the end of the year, it wants to start offering them in the US, where they will require a medical prescription, like those from competitors.
By year's end, Dante Labs plans to expand its menu to more than 50 tests by adding assays for specific cancer types, diseases such as Parkinson's and Alzheimer's, and a test that covers a large number of rare inherited diseases.
The company also wants to partner with patient and other organizations that focus on specific diseases to provide testing to their members.
Customers ordering one of Dante's tests receive a saliva collection kit in the mail, which they return to the company. Dante sends their sample out to one of its partner laboratories, which has expertise in the specific test ordered.
Partner labs currently include Stab Vida in Portugal, Source BioScience in the UK, Aciobiom in France, and Macrogen in Korea. Riposati said the firm only works with labs that have demonstrated certain quality standards, for example by being ISO-certified, CLIA-certified, or being an Illumina-certified service provider.
At the moment, the labs perform both the sequencing and the data analysis and provide a report of the results, but Dante is developing its own bioinformatics pipeline with Seven Bridges, which offers a cloud-based bioinformatics platform.
Dante uses Amazon Web Services to store the data in the cloud, a service that Riposati said is compliant with HIPAA regulations in the US and the European Union's Data Protection Directive. Customers' identifying information is also stored in a different database than their genetic information, which he said adds another layer of security in case of a hack.
Customers receive a report with their results via email, which takes 3 to 4 weeks for the targeted disease panels and 6 to 8 weeks for the exome and genome tests. The report is in "plain English", Riposati said, "so even people without genetic knowledge can read and understand it." Customers can also request their raw sequence data, which the company provides to them free of charge.
Although no medical prescription is required for testing, Riposati said customers have access to optional pre-test and post-test genetic counseling at no additional charge, a service that is not mentioned anywhere on the firm's website. Counseling is provided both by staff members and outside contractors, he said.
The website also provides no information about what genes or medical conditions the whole-genome or whole-exome tests analyzes. Riposati said reports for those tests are customized, "depending on the results of the genome/exome sequencing."
In addition, no sample test reports are currently posted on the firm's website but Riposati said they are available to customers on request. An example of a standardized report for the BRCA1/2 test provided by Dante offered little specific information.
"Your DNA resulted positive for a pathogenic mutation in the BRCA1 gene listed above," the report stated. "This means that your risks of developing breast and ovarian cancer are significantly greater than that of the average."
"The result does NOT mean that you have a diagnosis of cancer or that you will definitely develop cancer in your lifetime. Your actual risk may be different based on other genetic and environmental factors. Don't panic. Now that you know that your risk of developing breast and ovarian cancer is significantly greater than that of the average women, you can adapt your lifestyle, diet, workout and medicine basing on this result. The Dante Labs team of scientists is at your disposal. We will be able to address all your question by email or telephone. We will give you all the tools to enable you to live a longer and healthier life," the report concluded.
Professional societies have been cautioning about DTC genetic testing for medical purposes for many years. In a statement published in 2010, the European Society of Human Genetics, for example, put forth a number of requirements DTC companies ought to fulfill, among them providing "information about the purpose and appropriateness of testing" in advance and offering "genetic counseling appropriate to the type of test and disease."
According to Riposati, Dante Labs' customers appear to be "very well informed about DNA tests" despite having no formal training in medicine and genetics.
Others disagree that customers can inform themselves appropriately. "I cannot believe that this would replace genetic counseling, especially not given the broad realm of the hereditary diseases that are included in the tests," said Gert Matthijs, head of the Laboratory for Molecular Diagnostics at the Center for Human Genetics at KU Leuven University in Belgium. "I am strongly against DTC tests, certainly if they include predictive tests for monogenic diseases, like BRCA1/2," he said.