Sarah Ford | February 18, 2014

A Blood Test Hits the Market That Could Replace the Biopsy and Potentially Save Lives

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鈥婤y James Temple

A Redwood City, Calif. startup believes it has developed a novel cancer test that could spare patients the pain of biopsies and zero in on more effective treatments.

will announce Tuesday morning that it鈥檚 beginning to sell a genetic screening tool that relies on blood samples rather than tissue to a limited number of cancer clinics.听Separately, the company will reveal it raised $10 million in a funding round led by Sequoia Capital last year.

The company has been evaluating the Guardant360 test听for nearly two years with major cancer centers. The听听has certified the tool under federal rules governing laboratory diagnostics.

That means it meets the safety and accuracy standards necessary for labs to market the tests and for doctors to use them in considering treatment options. But critically, it鈥檚 not an indication yet that the results of those tests will extend or save lives. Proving that could require years of additional trials.

But here鈥檚 why the new test might matter:

Cancer occurs when genes go awry, when just a few of the six billion letters in our DNA get scrambled. Those mutations produce proteins that trip up a cell鈥檚 normal function 鈥 often leading to uncontrolled growth.

For decades, scientists have been studying the mutated genes that give rise to cancer in the hope of better understanding the 200 or more forms of the disease and developing targeted treatments, with some success.

But one critical problem is that cancer continues to mutate, sometimes in response to therapy itself.听The tissue taken for the initial biopsy 鈥 often painfully, invasively and expensively听鈥斕齧ight or might not represent the cancer in a person鈥檚 body months later.

鈥淐ancer is constantly changing,鈥 said Helmy Eltoukhy, chief executive of Guardant. 鈥淎 lot of drugs do well for three months, six months or a year, but then they start to fail.鈥

This is well known. But doctors and patients often don鈥檛 go back for additional biopsies due to the pain or expense听鈥 or because they couldn鈥檛 extract samples in the first place, as is often the case for brain tumors. Instead, they continue with costly treatments that worked against the cancer the patient had, rather than the cancer he or she has.

Eltoukhy听and his colleagues hope the cheaper and less invasive option means patients will take tests more often, either to identify the most effective treatment at the time or to spot early signs of a recurrence.

Warren听Hogarth, a Sequoia partner who joined Guardant鈥檚 board, said the Menlo Park firm invested in the company because of the potential to transform cancer treatment by applying information technology to medicine.

鈥淭he price of genomics and other data in health care is coming down significantly faster than Moore鈥檚 law 鈥 [producing] actionable data at the point of care,鈥 he said.

It has long been known that blood carries genetic material from the dying cells of tumors, but the fragments are in such low concentrations that it has been difficult to reliably read the information. It鈥檚 akin to a low resolution photograph: As you zoom in, the details become a meaningless blur.

But Guardant has developed a听new way of preparing samples听鈥 through a proprietary process they declined to share听鈥 that allows them to effectively capture higher-resolution snapshots of the tumor fragments when they sequence the genome. The company says it improves detection sensitivity by 鈥渨ell over 100-fold.鈥

鈥淚t adds a much more sensitive approach 鈥 and accuracy,鈥 said Dr. Dave Hoon, director of the sequencing center at in Santa Monica, Calif., and an adviser to the company. 鈥淭his brings a whole new dimension to monitoring patients.鈥

Dr. Hoon, considered a pioneer in the use of cancer DNA in the blood, will present findings on Tuesday at the in San Francisco showing the test spotted genetic alterations in cancer for almost 90 percent of patients. The trial, conducted at the John Wayne Cancer Institute, included 250 people with various stages of breast, colorectal, lung, prostate and skin cancer.

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