CHICAGO – Startup LifeVault Bio, which offers personal biobanking, small-panel genetic testing, and analysis under the GoodCell name, is trying to break new ground by creating metrics for measuring cell quality. This, company officials said, will help assure researchers and clinicians that the samples stored in the biobank will be most useful for future testing.
"We want to be the gold standard behind how you measure quality of cells," said Cofounder and CEO Trevor Perry.
"We're developing a measure where we can quantitate and annotate somatic DNA damage and overall genetic integrity of cells over time," added Brad Hamilton, cofounder and chief science officer of Waltham, Massachusetts-based LifeVault. Ultimately, he added, GoodCell wants to make available the best cells possible for potential use in patient-specific therapeutics and disease risk assessment.
This concept came from David Scadden, codirector of the Harvard Stem Cell Institute and the third cofounder of LifeVault, who touted the value of personal biobanking and cell quality to Perry and Hamilton. The two LifeVault officers were partners with the Harvard Stem Cell Institute when they worked together at StemGent, a company now owned by Japanese stem cell products company ReproCell.
LifeVault will pursue the cell-quality work through a soon-to-launch subsidiary dubbed GoodCell Diagnostics.
In December, LifeVault Bio said that it closed on its first major financing round, worth $5.6 million, including $2.6 million in investments and a $3 million convertible note. That money will, in part, support the Good Cell Diagnostics launch.
LifeVault Bio did not identify the investors or lenders, but Perry said that the equity partners are primarily "family offices" — private wealth management advisory firms — and angel investors who believe in the concept of personal biobanking.
Perry acknowledged that it will take many millions of dollars to maintain the biobank and build its software.
LifeVault was founded in December 2016 but took more than a year to test its facilities and technology before launching the GoodCell brand. "We just wanted to make sure that we had absolute operational integrity before we started to actually commercialize the products," said Perry, who has a background in pharmaceutical sales and business development. He also was a combat medic in the US Army.
The company contracts with a network of CLIA-compliant and CAP-accredited laboratories that meet GoodCell's quality-control standards, including for sample integrity, sample blinding, and privacy protection, Hamilton said.
The GoodCell biobank is housed at two facilities in New Jersey and Indiana, both hosted by RUCDR Infinite Biologics, a unit of Rutgers University's Human Genetics Institute of New Jersey. Together, those sites contain nearly two football fields worth of liquid nitrogen storage capacity, Perry said.
RUCDR also is measuring cell quality for its own work, but not to any standards that LifeVault has developed. "It's the right thing to do," said RUCDR Infinite Biologics COO Andrew Brooks said.
That organization at a minimum takes three steps to ensure cell quality, according to Brooks: measuring cellular viability and recovery; measuring molecular health of cells; and performing a functional analysis. He said that this is not necessarily what LifeVault is planning to do.
For GoodCell, the cells and plasma are stored in small "microvials" to maximize the amount of material available, according to Perry. "Our goal is to be very agnostic when it comes to how cells can be used, how plasma can be used," he said.
Hamilton said that the GoodCell direct-to-consumer product has three levels, all based off of a single blood draw: storing young, healthy blood cells; analyzing the DNA in those cells; and conducting physiological testing based on those samples.
"It's a comprehensive, holistic solution," Hamilton said, which he said sets GoodCell apart from companies that just offer biobanking or just offer lab tests.
GoodCell sends sample kits to customers' homes, who then schedule blood draws with the company's network of mobile phlebotomists. Those phlebotomists collect 40-ml blood samples from patients, then ship the samples in temperature-regulated packages to an affiliated lab.
Those labs break each sample down into cellular, DNA, and plasma components and test the DNA for genetic predisposition to disease, then store the material in a GoodCell biorepository for future retesting. Individuals retain ownership and decide who gets to use their samples for clinical and research purposes.
This, according to Perry, puts patients firmly in control of how their samples are used.
The company delivers genetic reports back to customers based on the ACMG-59, a set of 59 genes that the American College of Medical Genetics and Genomics recommends that labs report secondary findings from when performing clinical exome and genome sequencing tests. This panel covers risks for certain cardiovascular diseases and inherited cancers.
GoodCell provides a physician of record from a pool of doctors licensed in all 50 states for the ordering and delivery of test results from banked specimens. The company said that is in the process of hiring genetic counselors to support its customers as well.
The keywords for GoodCell are "control" and "actionability," according to Hamilton. The company tries to identify clinically actionable and medically important elements in the ACMG-59.
"People want to have control over their health and their future," he said. "The idea of being able to understand risk, track risk, and then potentially have action to take care of that risk is something that resonates with just about everybody."
GoodCell tests originally were sold only to individuals through the company website, but LifeVault has since also added partnerships with healthcare providers. The company did not identify these partners, but said in an email that "there are many MDs already involved with the company and product."
When expanding into the commercial realm, the company initially set out to talk to physicians in search of feedback about the concept of personal biobanking.
In doing so, GoodCell representatives left testing kits in physician offices and asked them to have conversations with patients about biobanking when ordering genetic tests. "When we came back in, the kits were gone," Perry said. It turned out that the doctors were taking the kits for themselves and their families.
"The feedback we got from them was that ultimately direct-to-consumer would be the bigger value to them because they'd be able to be champions," Perry said.
"As a company, we decided that going through direct-to-consumer [channels], but also partnering with different larger organizations that have like-minded customers is really the correct way for us to educate and to create trust and loyalty with the brand and with GoodCell as a whole."
Another key component of the GoodCell offering is analytics. At the same time the company announced its fundraising, LifeVault Bio also said that it had named longtime technology executive Anthony Bay to its board of directors.
Bay, cofounder of online video producer Uproar, is former global head of digital video at Amazon. He also is a former CEO of Rdio, a music streaming service that was sold to Pandora. In the 1990s, Bay held executive positions at Microsoft and Apple.
"We've decided to marry up what we think are the best minds in life science and healthcare with some of the best minds in software technology," Perry said of the addition of Bay to the board.
Perry said that he, Bay, and Scadden had a conversation several months ago about harnessing analytics technology to make the test results actionable.
All this information is delivered through a health dashboard that serves as GoodCell's main engagement point for customers. The dashboard displays static data about an individual's DNA and banked samples as well as phenotype information such as the progression of cholesterol levels over time — aggregated from other lab tests, with patient consent — and allows patients to invite their physicians into the portal.
"You're going to want to monitor where you're at now, but also monitor it over time to see how you're progressing against national averages and determine whether you need to have a conversation with your physician," Hamilton said.
Having patient and family history in the dashboard helps doctors and patients develop additional testing plans. If an individual who tested positive for familial hypercholesterolemia and had a relative with high cholesterol or cardiovascular disease, for example, GoodCell will be able to develop a more customized testing package to monitor the progression of cholesterol levels, Hamilton said.
"Those will be built into the health dashboard that the consumer ultimately owns, controls, gets to navigate, and then in the future share with their physician as well. That's the type of information that we aggregate and anticipate aggregating in the future," Hamilton said.
Hamilton said that while GoodCell now is focusing on the ACMG-59, the company has plans to add testing for risk of neurological disorders and pharmacogenomics. People who bank their samples now can opt for future tests as they come online.
"You can think of this as a linear process, in the sense of somebody makes the deposit with us. The DNA and the blood plasma serve as the information resource," Hamilton said. "Your DNA gives you that roadmap, that predisposition."