This week’s news that the Securities and Exchange Commission charged Theranos and its CEO with fraud put the troubles of the company back into the spotlight. For those of us in the field of liquid biopsy, Theranos has cast a long and persistent shadow on what’s clearly one of the most promising areas in cancer care — using blood tests to improve detection, diagnosis, and treatment and, more broadly, advancing the reality of precision medicine in cancer.
The long-unfolding Theranos story has chilled investment and primed clinicians to be wary of emerging blood tests, all to the detriment of patients whose cancer care may benefit from less invasive blood-based biopsies that can detect and pull critical information from genes, proteins, and cancer cells that have shed into the bloodstream.
What’s the silver lining for those of us in the field? The Theranos saga set the stage for an unprecedented level of collaboration and data-sharing across companies working to develop liquid biopsy technologies.
Our team began working as a pilot project under the Biden Cancer Moonshot, convening companies and asking that they contribute their own proprietary data to a shared, publicly available data commons. At the time, many experts told us it was overly ambitious and a pie-in-the-sky endeavor, citing a highly competitive and diverse field. Yet, we exceeded our own best expectations, with 30 partners joining the new, independent nonprofit BloodPAC Consortium. As each new member signed on, we heard a common theme: “Collaborating to compete” offered the best path forward for the field.
Our work in the first year, while decidedly unsexy, was unambiguously essential and productive. We’ve drawn on the five terabytes of raw data contributed by members to help define new standards and protocols for liquid biopsy technologies.
The first phase of our effort focused on defining the basics of conducting credible, rigorous, replicable research. The next phases of our work will focus on defining how to analyze data consistently and how to measure the clinical impact of these tests. It’s highly technical — “in the weeds” — and if you nodded off reading the last two sentences, we won’t blame you.
But blood, by nature, is highly dynamic and there is a long list of variables that can affect any given blood sample. Establishing the signposts of good analysis and evaluation and agreeing on what “good” looks like, from research to clinical use, is exactly what’s needed to accelerate the development of liquid biopsy, and get these technologies out of the lab and into the hands of clinicians to benefit patients.
Yet, agreement on standards and protocols among those developing the technologies – industry and academia – can only take us so far. That’s why the consortium has also engaged with policymakers, including the FDA, to align early with the stakeholders who may review and assess the technologies. This engagement is critical because we know that when the pace of scientific innovation outruns the existing regulatory framework, it can slow efforts to bring new technologies to patients. These early alignments between the FDA are aimed to accelerate the translation of scientific innovation to the clinical setting and catalyze rapid advances in the field.
Though the Theranos story served as a backdrop for the collaboration in liquid biopsy, there is a lesson here for all those innovating in the life sciences sector. Any new technology or approach can, and should, be met with healthy skepticism by all stakeholders, including investors, clinicians, professional societies, patients, and insurers. Without a critical eye on the science, we will find ourselves in a scientific Wild West instead of exploring a promising new frontier.
The stakes are high. If we want to realize the full potential of liquid biopsy technology, those of us in the trenches must come together to build the infrastructure of collaboration and communication needed between industry, academia, and regulatory agencies. We’re working in a unique moment to define the scientific rigor and quality that will help propel our field past the turmoil brought on by one company’s story. Ultimately, we’re creating the checks and balances needed to transform the way we detect, diagnose and treat cancer, for the benefit of every patient.
Lauren Leiman is executive director of the independent, nonprofit Blood Profiling Atlas in Cancer Consortium (BloodPAC) and Seema Singh Bhan is vice president of public policy at Foundation Medicine Inc., one of BloodPAC’s 30 members.
Liquid biopsy has adoption problems, but I think they have more to do with utility than Theranos.
Such cooperation and common sense seems sorely lacking today. Bravo
Nice article. Very nice.
I cut my white collar teeth in QC in a forensic-level (litigation support) environmental and bioassay radiation lab in Oak Ridge in the 1980’s. When I first learned of Theranos, my Dubiety Meter went on ’tilt.” I subsequently covered them skeptically on my KHIT.org blog (I do digitech writing in the health care space).
I’m about to post an update citing and linking two recent Science Magazine reports on developments in cancer detection blood assays. I will have to fold this article into that reporting.
It’s not of merely academic interest to me. My younger daughter was dx’d with Stage IV pancreatic cancer a year ago. She is now under hospice care here at home. Had she had access to efficacious pre-symptom cancer blood tests, she might have had a reasonable shot at survival.