SAN FRANCISCO (GenomeWeb) – Startup Rainbow Genomics is partnering with US organizations to provide genetic testing in Asia. The firm, which is based in both Hong Kong and the San Francisco Bay Area, launched in 2016 and currently offers exome sequencing-based diagnostic tests for undiagnosed diseases, hereditary cardiovascular disease, and hereditary cancer risk, as well as an exome sequencing test for healthy adults who want to know their risk for a variety of inherited diseases.
The company is focused on offering tests primarily in Japan and Hong Kong initially, and does not plan to enter the mainland China or US markets in the near term, Daniel Siu, founder and CEO of Rainbow Genomics, said. There is a need for high-quality next-generation sequencing tests in Asian countries and Rainbow's goal is to couple evidence-based genetic testing with US medical standards, he said. Sequencing is done at Rainbow's CLIA-certified and CAP-accredited laboratory in Hong Kong, and the company has partnered with outside organizations for clinical interpretation and report generation.
Currently, Rainbow Genomics has partnerships with Baylor Genetics, the University of California, Los Angeles' Clinical Genomics Center, and OneOme. Japan-based Saitama Medical University and Juntendo University provide additional clinical interpretation.
The market for genetic testing in Asia is very different from the US, Siu said. In the US, individuals are predominantly getting genomic tests through healthcare providers, including for noninvasive prenatal testing, cancer tumor profiling, or rare disease diagnostics. Companies mostly offer tests to diagnose diseases rather than to predict an individual's likelihood for developing diseases, since insurance companies will not reimburse for predictive sequencing tests.
However, Siu said, because the genomic testing market in Asia is solely self-pay, there is a large market for screening tests for asymptomatic individuals. As such, he said, there has been a huge number of companies popping up developing tests that have "latched on to this consumer desire but has little evidence" supporting their tests. For instance, a number of companies have developed tests that claim to determine whether an individual is likely to succeed at music or math, or that analyze so-called beauty genes.
In addition, he said, as China's economy grows, there is an increasingly growing business of Chinese medical tourists. Such individuals have money to pay out of pocket for medical services in Hong Kong or Japan. In both places, Siu said there are clinics popping up that specifically cater to this market.
Rainbow's primary product is clinical exome sequencing. Samples are collected and sequenced locally and then the raw data is sent either to UCLA or Baylor for interpretation and report generation. The turnaround time is one to two months and tests cost between $2,000 and $5,000, Siu said, depending on the specific test.
The tests all start with exome sequencing, but depending on the specific test, may only analyze a subset of genes. For instance, the hereditary cardiovascular disease test focuses on around 200 genes representing 23 conditions. In addition, individuals have the option of getting an incidental findings report, which includes American College of Medical Genetics and Genomics' recommended list of 59 genes. The OneOme pharmacogenomics test can also be paired with any of the tests and that includes testing for response to over 340 medications.
Rainbow also offers exome sequencing and interpretation for healthy adults. Baylor Genetics performs the interpretation of that test, which includes testing for Mendelian disorders, hereditary cancers, hereditary cardiovascular disease risk, carrier screening, and pharmacogenomics testing. In addition, one of Rainbow's partners in Japan will provide more population-specific interpretation for myocardial infarction and atrial fibrillation.
The exome diagnostic tests for individuals with a suspected genetic disorder are performed at the UCLA Clinical Genomics Center. For that test, individuals receive results related to their phenotype and also have the option of getting the ACMG incidental findings, Siu said.
The tests all include post-test genetic counseling, Siu said. Rainbow has its own part-time genetic counselors and contracts with genetic counseling organizations, Siu said. In addition, for tests that are ordered through Baylor Genetics, patients have access to Baylor's Consultagene service, where genetic counseling can be provided via video conference, phone, or email. Rainbow also offers interpretation for non-English speaking customers.
Although the market in Asia is largely consumer driven and self-pay, customers must still go through a Rainbow-authorized clinic to order the test. Patients also sign informed consents where they determine which test they want, whether they want incidental findings, and whether they are willing to make their sample available for research.
Siu said that most patients do consent to research and researchers are using that data to identify Asian-specific variants. "We see variants that are not as prevalent in US populations," he said. The company plans to submit an abstract to the American Society of Human Genetics annual meeting this year on some of its findings. "We want to do our part," Siu said. The goal, he said, is to build up databases of Asian-specific variants to contribute to a broader understanding of genomics outside of just Caucasian populations.
Although a relatively new company, founded in 2016, Siu said the firm has grown quickly. Last year, it ran a few hundred tests and this year it expects to run between 1,000 and 3,000 tests. "We're seeing a very rapid ramp in the market," he said.
In addition, he said, there is not yet a lot of competition in the market that Rainbow serves. Although genomic testing is picking up rapidly in China, including both diagnostic disease-specific testing as well as screening tests for asymptomatic adults, Siu said that in other Asian countries, the field is still very new.
Siu said that Rainbow plans to launch additional products. For instance, it recently launched a pediatric exome sequencing test, that analyzes around 1,000 childhood-onset disorders, for asymptomatic children. The company also aims to develop its own products outside of its partnerships with Baylor and UCLA. The goal is to have a "combination of these really powerful exome tests" analyzed by US institutions, "as well as some interesting tests targeted to the local population in Asia-Pacific," Siu said.