While the last decade saw the rise – and sometimes fall – of a number of direct-to-consumer genomics firms, including 23andMe, Navigenics, and Decode Genetics, the market for DTC proteomics has remained largely unexplored.
A new DTC proteomics and metabolomics firm hopes to change that. San Francisco-based Talking20 launched two weeks ago at the Open Science Summit in Mountain View, Calif. Since then the company has sold several hundred kits to interested users, founder and CEO Heather Heine told ProteoMonitor.
Currently, Talking20, which takes its name from the body's 20 different amino acids, measures levels of five vitamins and hormones – vitamin B1, vitamin B9, testosterone, estradiol, and progesterone – in customer samples. It aims to add protein biomarkers to its panel within the next month, Heine said.
The company uses mass spectrometry to analyze dried blood samples mailed in by customers. It charges $10 per analysis. Customers can also purchase a $1,000 "power user" package, for which Talking20 will measure all the metabolites – but not the proteins – in its catalog once a month for three years. The company is also offering three $100,000 "founding lifetime membership packages," for which it will measure every analyte – metabolites and proteins – in its catalog once a month for the rest of the customer's life.
Thus far, Heine said, the firm has sold three "power user memberships" and around 300 of the $10 single analysis kits.
Heine, who graduated this year from the University of British Columbia's MD/PhD program, noted that because the company is largely being "bootstrapped" by her and several colleagues, it doesn't currently have the equipment in house needed to offer protein biomarker tests. She said that for the time being she plans to outsource these tests to an outside lab and is in discussions with facilities at Stanford University and the University of California, San Francisco, as well as two area contract research organizations.
Currently Talking20 runs its tests on a Shimadzu LC-MS 2020 single quadrupole mass spec and, Heine noted, is pushing the instrument's capabilities both in terms of its measurement abilities and throughput.
Ultimately, Heine said, Talking20 hopes to raise $1.1 million in funding to purchase two triple-quadrupole mass specs – one for metabolomics and one for proteomics.
"Our dream machine is an automated dry blood spot crunch mass spec," she said. "We load our filter cards right on, and then it punches them for us and reads them for us, so we don't actually have to touch them, which is ideal because it's much cleaner and the results are much more accurate."
Equipment aside, there is also the question of what proteins the company will measure, and to what purpose. While there has been significant research into disease protein biomarkers, very few markers have been clinically validated, and even fewer are approved as screening markers suitable for use in the sort of general population customers Talking20 is targeting.
Heine said she would like to start by adding known protein markers to the panel – analytes like carcinoembryonic antigen and prostate-specific antigen.
Beyond that, she said that "because this kind of came out of the citizen scientist, crowd-sourced community," she would "like to give people proteins and let them sort of play with the data a little bit."
"My thought is that we may not know what all of these proteins do, but I would like to add proteins [in terms of] tiers of understanding," Heine said. "Maybe we have proteins where we pretty much know what they mean. [Then] proteins where it's still pretty much a gray area – [we offer] all the references and literature. [For] proteins where we have no idea … we just qualify ourselves and explain that, and then we just let people see it if they want to."
Given that the Talking20 tests could provide clinically relevant data, the service might find itself contending with regulatory issues. Heine said that Talking20 does not plan to offer "any clinical diagnoses or claims at this time" or "interpret the data at all." Nonetheless, based on the experience of the DTC genomics market, it seems likely that regulatory bodies like the US Food & Drug Administration will take an interest in the firm's activities.
For instance, after launching their first tests three years ago, DTC genomics firms maintained for several years an uneasy relationship with the US Food and Drug Administration, marketing their services largely as laboratory-developed tests over which the agency has traditionally exercised "enforcement discretion." In May 2010, however, in response to Pathway Genomics' plans to sell genomic sample-collection kits at retail stores Walgreens and CVS/Caremark, FDA sent letters to four major genomic testing companies instructing them to submit their products for review and clearance by the agency (PGx Reporter 06/16/2010).
Just over a month later, the Government Accountability Office issued the results of its own year-long investigation of DTC genomics testing, concluding that the companies' test results were "misleading and of little or no practical use to consumers" (PGx Reporter 07/28/2010). Since then, several firms, including Pathway and Navigenics (which has since been acquired by Life Technologies), have changed their business models to require physician involvement in the testing process.
Talking20 isn't alone in pursuing the DTC proteomics market. Several other researchers are also exploring DTC proteomic testing, although typically in a more directed fashion than the model Heine described.
For instance, in 2010 Stephen Johnston, director of the Arizona State Biodesign Institute's Center for Innovations in Medicine, launched the biotech firm Healthtell to commercialize protein diagnostics based on an immunosignaturing technique developed in his lab (PM 2/4/2011). The company is currently focused on diagnostics for breast cancer and Valley fever, but, Johnston told ProteoMonitor in a 2011 interview, the ultimate goal is using the technology as a regular screening test for the early detection of a range of diseases.
"The idea is that people could send a drop of blood through the mail [as a dried blood spot], and we could do the [immunosignature] on that," he said, describing the service as "like 23andMe but in real time."
SpotOn Clinical Diagnostics, a spinoff from King’s College London and Guy’s and St Thomas’ NHS Foundation Trust launched by King's College researcher Neil Dalton, is also exploring potential DTC proteomics products, in this case mass spec-based tests measuring things like albumin/creatinine ratios to monitor renal and cardiovascular health or glycated hemoglobin to monitor diabetes (PM 12/9/2011).
“We are working on direct-to-consumer. Because that is personalized medicine," Dalton told ProteoMonitor in an interview last year. “These markers have very low individual variability but relatively high variation across a normal population. Therefore you miss the changes. The key is to track an individual over time."