How much does it cost to bring to market a diagnostic test that’s able to measure cancer without a tissue biopsy?
In the case of Trovagene, almost $100 million.
That’s the cumulative loss, or expense including salaries, R&D, and office space, the money-losing San Diego biotechnology outfit has run up since 1999, when it set out to test for cancer from a cup of urine. Just like recently developed cancer blood tests, the diagnostic the company started offering in May searches for telltale scraps of tumor DNA released by dying cancer cells. The amount of tumor DNA that ends up in urine is a readout, the company says, of whether a tumor has been destroyed or is still growing.
The idea of such liquid biopsies has leapt to prominence in just the last year. Cancer researchers now expect that the tests will offer a noninvasive way to monitor cancer, find the genetic mutations driving a tumor, or even diagnose it early, before symptoms start. It’s an innovation so big that Wall Street analysts at JP Morgan expect demand for liquid biopsies to rocket toward $20 billion a year within five years, from about $100 million today.
The first DNA blood test for cancer in the United States was commercialized in 2014 by Guardant Health, a venture-backed California company, and tests to spot cancer DNA in blood, urine, or spinal fluid are now in development by a growing number of companies but remain a risky bet for investors.
One pioneering researcher, Dennis Lo, is now tracking more than 20,000 people in Hong Kong to see whether blood screening can catch liver cancer early. Some of his early and ongoing work was paid for by a $1 million grant from the Kadoorie Charitable Foundation, the charity of Hong Kong billionaire Michael Kadoorie, and he later won a $4.25 million award from the Hong Kong government. “It took us about 10 years to convince people to fund us,” he says. Lo says he recently cofounded a company called Cirina to develop blood tests, and he expects initial financing of $12 million from investors.
Investors in the new tests could be disappointed, because while developing a new diagnostic can cost as much as creating a new drug, it’s notoriously hard to make any money off diagnostic tests. Consider Foundation Medicine, a company based in Cambridge, Massachusetts, that started testing the DNA of tumor tissue samples in 2011 but is now racing to launch a liquid biopsy using blood. The company has deep-pocketed venture backers including Google Ventures, but it has spent $192 million developing its tests and continues to lose millions of dollars every quarter.
It’s still unclear how the U.S. Food and Drug Administration plans to treat this new group of tests. Another challenge: insurance reimbursement can be uncertain. And patents that once protected such investments and kept competitors away are being overturned.
In 2013, the U.S. Supreme Court said genes aren’t patentable. Since then, other courts have extended the reasoning to liquid biopsies. The presence of cancer DNA in the body’s fluids, they say, is also a “phenomenon of nature” and can’t be patented either, even if you discovered it.