NEW YORK (GenomeWeb) – Color Genomics is expanding its reach beyond the US, offering its $249 breast and ovarian cancer genetic risk test to patients and providers in more than 100 countries, including Canada, the UK, many other European countries, and Australia.
The global launch comes a year after the company, based in Burlingame, California, released its Color Test in the US. The next-generation sequencing-based assay analyzes 19 breast or ovarian cancer predisposition genes, including BRCA1 and BRCA2, for cancer-causing mutations.
Othman Laraki, Color's president and co-founder, told GenomeWeb that over the last year the company had received requests for its test from all over the world, as well as from US patients with positive test results who wanted family members abroad to be tested. In response, the company decided to make the Color Test available internationally. Â
Color Genomics, which has more than doubled its staff since a year ago, is currently working with three local distributors — GenoMill Health in Finland, which also offers BGI's NIFTY noninvasive prenatal test; Fugene Genetics in Israel, which also distributes Roche's Ariosa Harmony NIPT; and Genoks Technology in Turkey, which offers both BGI's NIFTY test and BGI's Sentis hereditary breast and ovarian cancer test, according to their websites. In other countries, individuals and providers can purchase the Color Test kit directly through Color's website.
As in the US, all tests are physician ordered, either by a patient's own doctor or by a physician who is part of Color's network of independent third-party physicians. Doctors can order the test through the company's online provider platform, which Color launched earlier this year, and which also lets providers track the status of their orders and download the test reports.
"Over time, we hope to develop local partnerships to facilitate outreach to physicians in every country," Laraki said. In the future, this will include access to local genetic counselors providing services in languages other than English.
Color is also working on making its test available in additional countries that it cannot currently access due to various restrictions and requirements, he said. Missing from the list, for example, are countries such as China, India, Brazil, Argentina, Germany, and France.
Pricing for the test — currently $249 — is the same for international as for US customers, except for additional shipping costs, and customers abroad will receive the same services, which include phone-based genetic counseling.
All samples will continue to be analyzed in Color's California CLIA laboratory, which obtained CAP accreditation last fall, a credential that is important to many European countries, Laraki said.
Since the launch of the test a year ago, Color has seen "a lot of interest across the board," he said, though it is not currently disclosing sample volumes.
The Color Test uses Agilent's SureSelect for target enrichment and Ilumina's NextSeq 500 for sequencing, and analyzes the exons, intron/exon boundaries, and certain introns of 19 genes. Color has validated the test in a study of 490 blinded clinical samples and 17 cell lines, achieving 100 percent accuracy for 304 previously validated variants, including single nucleotide variants, indels, and copy number variants. Additional validation studies that include rare and technically challenging variants are currently underway, Laraki said.
The firm has committed to contributing results, with patients' permission, to open databases and is currently preparing its first submission of a batch of data to the ClinVar database and the Broad Institute's Exome Aggregation Consortium (ExAC).
Last fall, Color announced an employee benefits program under which companies cover at least 50 percent of the Color Test's cost for their employees. Besides Color, 18 companies have joined the program so far, including Visa.
In addition, Color is involved in a number of research collaborations — some of them unannounced — for example, the University of California's $14 million Women Informed to Screen Depending on Measures of Risk (WISDOM) study. Over a period of three years, Color will provide genetic testing for more than half of the 100,000 participants the study plans to enroll.
The launch of the provider platform in January has made it easier for physicians to order and track tests and allows them to have test kits shipped either to their office or to a patient's home. And because many patients pay for the test out of pocket, doctors are no longer required to document family history and engage in paperwork for insurance preauthorization, giving them more time to spend with their patients, Laraki said.
In the US, the Color Test is now available in every state except New York — the company is currently waiting to be inspected by the New York State Department of Health.
Since last year, Color has grown from approximately 20 employees to a current 58, including a large team of software engineers and genetic counselors, Laraki said. It also has a number of consultant genetic counselors and it is collaborating closely with the genetic counseling team at the University of California, San Francisco. In addition, it has started building a commercial team, which includes a number of recent hires from Natera.
Color is also engaged in increasing access to cancer predisposition testing for patients who cannot afford it. As part of its participation in President Obama's Precision Medicine Initiative, the company recently pledged to double the number of underserved patients receiving the Color Test for free in 2016 through its Every Women Program. The program lets patients who purchase the Color Test kit make a donation to subsidize tests for others. Color has partnered with a number of cancer centers, including UCSF, the University of Washington Medical Center, Penn Medicine's Abramson Cancer Center, and the Morehouse School of Medicine to provide no-cost testing to needy individuals under that program.
Color currently has no plans for further fundraising. A year ago, the firm raised $15 million in a Series A financing round with lead investors Khosla Ventures and Formation 8 and contributions from individuals associated with Twitter, Yahoo, PayPal, Dropbox, Google, and Netflix. "We've been very fortunate in getting great backers, and the business has been doing quite well," Laraki said.