NEW YORK (GenomeWeb) – After launching its business with a focus on early cancer detection cancer, CellMax Life has now also begun offering germline DNA testing for detection of hereditary cancer risk mutations.
The company believes the new assay, called the CellMax-DNA Genetic Cancer Risk Test, will complement its planned slate of liquid biopsy assays for early cancer detection, the first of which it launched in Taiwan this summer.
In addition to working toward expanding that test, CRC-Protect, to the US market, the company also has goals to develop similar tests for breast and prostate cancer, among others.
Although many firms have now marked their intentions to develop blood-based genomic tests for early cancer detection, the field is still in its infancy.
Some leaders, like Guardant Health and Grail, have stated that they don't think technology to detect molecular signatures of developing cancer in otherwise healthy people is ready for prime time yet, and are pursuing comprehensive and potentially lengthy validation studies in order to demonstrate their tests can accurately and specifically detect incipient cancer in otherwise healthy people.
CellMax Life is not alone in pushing forward with a blood-based DNA test to detect early cancer much more quickly. For instance, Pathway Genomics entered the market in 2015 with a test it calls CancerIntercept Detect.
Soon afterward, it received a letter from the US Food and Drug Administration raising concerns that it lacked appropriate evidence for the clinical validity of detecting cancer mutations in the blood of undiagnosed individuals. Despite this, the company still lists the test as available online, though it has not yet appended any data that speak directly to the assay's sensitivity for detecting cancer mutations in asymptomatic people.
For its part, CellMax Life has said that its circulating tumor cell-based platform correctly identifies colorectal cancer in high- and moderate-risk individuals over 90 percent of the time, though this has also not yet been published in the peer-reviewed scientific literature.
It remains to be seen whether early actors like CellMax are able to capture a market for genetic early-detection tests ahead of companies taking a more cautious approach.
Hereditary cancer testing gives CellMax Life another business avenue in the near term, but could also provide a complement, or an adjunct to its planned slate of early detection tests, by identifying individuals who are at a higher risk of developing cancer, who would then be potential customers for these other assays.
Atul Sharan, CellMax Life's co-founder and CEO, told GenomeWeb that hereditary cancer testing fits into the firm's overall goals to provide testing that can shift the treatment of cancer to its earliest stages.
"We absolutely believe that the only defense is early detection, so we are focused on a multibiomarker approach [in that vein]," Sharan said. "But there is also lots of evidence that the germline [risk] testing approach can also help a lot of people," he added.
The new CellMax-DNA Genetic Cancer Risk Test covers 98 genes with relevance to 24 types of hereditary cancer using a proprietary next-generation sequencing method CellMax calls SMSEQ.
The assay is saliva-based, and is available at a promotional rate of only $149 through the end of 2016. Normally, it will cost $299, the company said.
Unlike early cancer detection, cancer risk mutation testing has exploded in the three years since the US Supreme Court ruled that Myriad Genetics could no longer patent isolated DNA sequences.
With a panel of 98 genes CellMax's test is on the upper level of available assays in terms of panel size, and at $299 it sits close to the lower limit in terms of price.
In contrast, Color Genomics sells hereditary cancer testing for $249, though its test currently covers only 30 genes. Invitae, which comes closest to CellMax's breadth with a 80-gene pan-cancer test, has an option whereby individuals without insurance pay around $475.
At the annual meeting of the Association for Molecular Pathology earlier this month, participants debated whether companies offering tests at prices this low could be making enough money to continue to innovate, and to provide high-quality results.
But Sharan said that competition in the hereditary cancer field has given rise to new direct-pay business models that don't require the marketing that contributes to the higher cost of testing for traditional companies.
"We are not losing money on these tests," Sharan added.
According to Sharan, consumers can order CellMax's new assay directly online or through the firm's provider network. He previously told GenomeWeb that patients who order through the company do interact with a physician, which would hopefully keep its offerings outside the FDA's purview.
These types of testing models remain controversial, however, and some other firms have been reprimanded by the FDA for employing models that track too closely to a direct-to-consumer paradigm.
In contrast, Color and other firms like Veritas have been able to avoid censure by being very clear that they take a hybrid approach in which consumers can order genetic tests online but then must discuss positive results in consultation with a medical professional.
Meanwhile, CellMax Life's first early detection test, CRC-Detect, is still only available in Asia, but Sharan told GenomeWeb that the company plans to expand this part of its business to the US before the end of next year to join the now-available hereditary cancer panel.
The firm is also working on its next screening assays, and recently shared data on early detection of prostate cancer from a study conducted with clinical collaborators.