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Arivale Branches Out With New Helix Products, But Proving Health Impacts Remains a Challenge


NEW YORK (GenomeWeb) – After announcing earlier this month in Seattle that it was updating its product menu, wellness firm Arivale officially launched two new services this week, which it calls Arivale Weight Loss and Arivale Heart Optimizer.

The products are being offered through consumer genomics firm Helix's online marketplace, which went live this July.

As announced this week, customers buying the two programs through Arivale directly can claim a special introductory price of $99 for the Heart Optimizer, and $49 for Weight Loss.

Through Helix, Heart Optimizer costs $159 and Weight Loss $169, including the company's $80 spit kit and genetic analysis.

In either case, purchasers receive analysis of their genetic sequence by Arivale, which began to integrate polygenic profiles relating to things like body mass index, waist circumference, and lipids (LDL, HDL, total cholesterol, and triglycerides) earlier this year.

Customers also get one in-depth phone consultation and 30 days of unlimited text communication with one of Arivale's registered dietician.

Alongside these new kits, Arivale has also rejiggered its flagship genetics and health biomarker-based coaching service, switching from what was a $3,499 year-long deal to a new "Arivale Baseline" program that costs $999 for an initial three-month intake, with the option to renew at $125 per month.

For the new starter price, customers receive a truncated introduction to the program, which includes initial genome sequencing and blood tests and three coaching calls supplemented by email and text communication.

Arivale CEO Clayton Lewis said that the goal with this shift, and with the two Helix offerings, is to increase access and drive adoption. Hopefully, being able to try the program for just three months and then choose whether to renew monthly will be an easier sell than a minimum one-year commitment at nearly $4,000.

"In goal of becoming more accessible, this provides a lower-risk opportunity to see what we do," he explained.

Coinciding with the shift, Arivale is also opening its services to a national audience, after initially limiting its business to the Pacific Northwest and California.

Predicating this expansion is the fact that the firm believes that the evidence is now there to persuade that its services actually improve users' health. In this vein, Lewis shared some internal data the company has now collected on how customers' blood biomarkers have improved from baseline measurements that were out of range when joining the program to their most recent numbers.

Analyzing 1,280 commercial cases, the company calculated that participants' out-of-range analytes have normalized by at least 21 percent on average.  

For example, the cohort has seen diabetes risk markers like fasting glucose, insulin, HbA1C, and HOMA-IR improve 21 percent from baseline, and inflammation markers like hs-CRP, IL-6, IL-8, and TNF-alpha improve by about 28 percent.

This data is unpublished. But Arivale did release a study earlier this year in Nature Biotechnology from the Institute for Systems Biology's Pioneer 100 Wellness Project, which followed 108 individuals using the company's combination of whole-genome sequencing, blood analyte tests, gut microbial analyses, and personalized coaching.

The resulting data provide a visualization of the complex ties between these different factors. Takeaways included several examples of polygenic scores correlating clearly with associated disease-risk analytes — for example, blood levels of DGLA in study participants were strongly linked to a polygenic score computed from genotypes in six variants associated with DGLA levels, the authors reported.

The results also exposed ties between things like serotonin and blood platelet function, and showed that inflammatory markers declined with enhanced microbial diversity in study subjects.

Looking at outcomes, the study supports Arivale's conclusion that its method results in net improvements in clinical biomarkers from baseline. According to the authors, the most significant changes for the P100 group were observed in vitamin D, mercury, and HbA1c levels, but researchers also saw consistent improvements in total cholesterol, diabetes risk, and inflammation markers.

Although promising, the impact of this data is limited by several factors. For one, without a control group to test against, analyte improvement results like these don't definitively prove whether the program outperforms what might have happened to these individuals in its absence.

Lewis also conceded that it is not possible to distinguish whether Arivale's method of coupling baseline genetics with repeat blood tests is necessary for the kind of improvements the firm is seeing, or if individuals might be able to make the same improvements through close monitoring of blood analytes and associated coaching — with no genetics involved.

The latter remains a crucial question considering that some other large studies have concluded that the impact of genetics on individuals' health behavior is limited.

Arivale is hoping that it can demonstrate that its monitoring and personalized coaching strategy can overcome this barrier, and Lewis said the company is currently working on a clinical outcomes study to analyze the impact of polygenic profiles on response to specific lifestyle interventions, which may shed more light on this question.

"Anecdotally, what we hear from our members is receiving the genetic information is motivational for behavior change," he added in an email.  "If they know they have increased risk, they want to 'double down' to address it and if they don't have genetic risk but the blood markers are poor, they know they 'have no excuse' and that motivates them."

With the two Helix programs, participants get much of the same baseline genetics analysis they would get via Arivale's full coaching program, but since coaches don't have blood analytes to look at, the wellness recommendations are based only on the genomic data and on self-reported health and lifestyle metrics.

As a result, these two services may also provide a way to distinguish the contribution of genetics, if the company is able to collect appropriate outcomes data.

Arivale has put up very clear firewalls in its business model, which limit its analyses to wellness-related, as opposed to disease-related information.

However, the company did report disease-associated variants in the P100 Wellness study that are recommended by the American College of Medical Genetics and Genomics.

Lewis also shared that the company has uncovered disease in at least one participant, and in other cases is finding what appear to be potential novel biomarkers of disease or of disease transitions. One example is a member whose second blood draw showed elevated lymphocytes and who was later diagnosed with leukemia by his physician.

In another case, a patient who had participated in the program was diagnosed with pancreatic cancer. The company then decided to reanalyze her blood tests using a broad proteomic platform, and found a single protein — related to the functioning of the pancreas — that was materially out of range as compared to the larger Arivale cohort.

Over the last several years, various companies have come forward with plans to develop cancer early detection or screening tests that detect circulating tumor DNA. Some, like Pathway Genomics, have even launched semi-yearly ctDNA testing services, somewhat akin to Arivale's model.

But Lewis said that with its focus on wellness, the firm doesn't have the right kind of partnerships to integrate liquid biopsy right now. "Dieticians can't speak to that, so what we have to do is partner with the right healthcare providers," he explained.

Meanwhile, Arivale is also looking beyond cancer. The company expects to soon launch a clinical trial with California's Hoag hospital, for example, which will analyze polygenic patterns in patients with Alzheimer's in the hopes of investigating genetic features that play a role in the progression of the disease and evaluating whether the company's personalized coaching can affect this.