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Amid Customer Complaints, Genetic Testing Firm Pathway OME Acquired by OME Wellness

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NEW YORK – Direct-to-consumer and clinical genetic testing company Pathway OME, formerly known as Pathway Genomics, has been acquired by one of its investors and has been rebranded as OME Wellness.

However, amid this acquisition, OME has faced complaints from multiple customers and groups about the San Diego-based firm's business practices and lack of response over the past year.

According to Pathway's site, OME Ventures acquired the firm's assets as of January 25. OME Wellness noted that it will retain the CLIA-certified, CAP-accredited laboratory of former Pathway Genomics in San Diego and continue offering lab services.

Pathway offers a variety of genetic tests through its own website and Amazon.com that the firm said offers insights for a customer's nutrition, cannabis experience, mental health, pain medication, cardiac disease, and skincare routine. Patients can also request genetic tests that Pathway performs from their healthcare provider to receive insights about their weight, health, and carrier status risk for rare diseases.

After mailing a genetic sample in via a saliva collection kit, customers receive a report that provides personalized recommendations based on their results within two to three weeks.

On Pathway's website, OME Wellness said it will continue to offer all of Pathway's kits, in addition to developing new products for clinicians' offices. For patients currently waiting for tests results they previously submitted to Pathway, OME said that "sample status updates and changes online will be updated within one to two days."

According to Michael Nova, chief innovation officer at Pathway, OME Ventures acquired Pathway in order to "keep the lab going" and will serve as a holdings company for Pathway. While declining to name the investor, Nova said that the individual has been involved in a series of Pathway's late-stage funding rounds. However, he declined to discuss the financial details of the acquisition.

Nova believes the acquisition was a good fit for Pathway because the firm wants to soon launch multiple business divisions, including a skin division and potentially a cannabis division.

"The lab is going to be the center of it all, and we have all these areas, which will not necessarily be spinouts, but separate divisions," Nova explained. "It just made sense to have an overall holdings company over it all."

Nova said that OME Wellness does not anticipate ditching any of Pathway's current genetic tests and is instead interested in offering all the firm's tests meant for both clinical and DTC clients.

In addition to creating skin and cannabis divisions, Nova said that Pathway will explore the use of artificial intelligence. He pointed to Pathway's OME mobile app that it has been developing since 2014, which uses IBM's Watson technology to pair individuals' health and genetic information with information from clinical trials to offer personalized feedback in response to users' wellness-related queries.

Nova claimed that the acquisition by OME Ventures has been smooth and has not affected customers at all, adding that any customer who has sent in genetic samples will receive the same report that the firm promised all along.

While Nova was unable to exactly recall when Pathway Genomics had changed its name to Pathway OME, the firm's Facebook page had changed its profile picture to reflect its new name in June 2018. The firm also referred to itself as Pathway OME for the first time in a press release in September 2018, when it partnered with San Diego-based Standard Process to assist patients and physicians with personal wellness and healthcare.

Nova claims that Pathway "had a little bit of a slowdown because of a reagent issue" in fall 2019 and therefore sent out a note to its customers, saying that they can "expect a three- to six-week lag time in getting their results."

"But people complain, because they have a right to complain and it's their money," he said. "We've either told them that 'You will get your results,' or 'We will refund you' and we have done that, either or, to just a few cases. And we haven't had that many cases."

Nova said that OME Wellness now expects to deliver results to its customers "in the next few weeks," which he noted could be around late February to early March. 

In response to the multiple customer complaints on Pathway's Facebook page, Nova argued that the firm receives customer complaints "all the time." He said that some customers called Pathway's client specialist line — which is the only phone number at the firm at the moment — and that Pathway has either responded via email or by phone several times without any follow-up response from the customer.

But, GenomeWeb has spoken to multiple customers who have assailed the firm's lack of response and poor customer service.

Mary Catherine Hames, for example, founder and CEO of genetic consulting firm GenetAssistant in Cullman, Alabama, noted that she had ordered FitIQ tests for her clients curious about fitness and nutrition testing. She explained that her company helps physicians and patients access testing, most commonly pharmacogenetics testing. 

After pre-paying $1,000 for the five tests back in September, Hames learned that her initial patient no longer sought to take the test. She therefore held on to it until another patient was interested in the test in November.

Mailing the first kit on Nov. 5, Hames was notified by Pathway on Nov. 14 that the firm had received the kit and was analyzing the saliva sample. After waiting about a month, she contacted customer support on Dec. 3 but did not hear any response.

"For most of the testing companies I use, DNA tests tend to be available in two weeks," Hames noted. "The standard is normally two weeks."

On Dec. 9, she reached out to a sales representative at Pathway who had initially contacted her about Pathway's assays. Unsure of what was going on himself, the sales representative mentioned that he had been fired and that Pathway had been dealing with high management turnover, and he provided Nova's contact information.

On Dec. 12, Hames was told by Nova that Pathway was grappling with reagent problems and would mail her results within a couple of weeks. Waiting to call back after the holidays, Hames then reached out to Nova on Jan. 6 asking for a refund and if she needed to discard the unused tests she had purchased, but she didn't receive a response.

"I've worked in a lab for many years, and when you get a reagent that runs out or goes bad, you can get a new one within a week," Hames explained. "I understand they had delays, but this amount of time for a reagent issue doesn't make sense, and there must be more going on."

Hames then contacted the sales representative once more and learned that Pathway, now OME, had been acquired by another company. She did not hear anything from OME until the firm sent an email on Monday morning this week about the acquisition and her genetic results, which notified her that the "existing agreement and account will remain in effect during this transition period and new agreements with OME Wellness will be established."

Ann Riggs, a New Hampshire-based customer searching for genetic testing to help improve her nutrition and diet, initially learned about Pathway Genomics through a website hosted by Falmouth, Maine-based Women's Transformation Center, which Riggs said at the time was touting the company's tests for patients.

Initially purchasing Pathway's FitIQ tests on Amazon.com in October for about $119.00, Riggs submitted the saliva test kit to Pathway in late October, which later notified Riggs that it had received her sample.

In mid-November, Riggs called the firm about her results and was told that it was still analyzing her genetic sample. She learned from a voicemail from Pathway that the analysis required about five to seven days, and that Pathway would send her an email two weeks later with the results.

Shortly after Christmas, Riggs called Pathway several times, requesting her genetic testing results and asking for a complete refund. When Riggs signed onto her customer profile on Pathway's website yesterday, she saw that the firm was still analyzing her sample.

As of today, Riggs has neither received an email nor a phone call from Pathway regarding her genetic results or the recent acquisition.

In addition, a representative of a clinic who asked not to be identified said Pathway has not returned calls or emails and that the company has reported its grievances to the College of American Pathologists, the San Diego Attorney General, as well as the Better Business Bureau (BBB).

However, Nova disputes that customer's claim and said that someone from Pathway is handling the issue.

On the BBB's website, Pathway currently has a score of "D-," a 1-star rating, is not listed as BBB-accredited, and is tagged with seven customer complaints within the last six months. The unanswered complaints about Pathway range from billing and collection problems to issues with Pathway's product and service behavior.

While Nova said that he cannot directly respond to the score "because those are customer issues," he believes that the complaints are "probably direct-to-consumer," and that "none of our clinical clients" are complaining about billing or product issues.

Pathway scientific advisory board

While the notification of the acquisition was listed on the site, former employees and members of Pathway's scientific advisory board (SAB) either declined to comment or mentioned that they were caught unaware of the firm's acquisition.

Jim Plante, who founded Pathway in 2008 and served as CEO until September 2017, was unavailable for comment. He currently serves as CEO of San Diego-based Klotho Therapeutics. Kamai Adawi, who served as CFO from 2014-2017 and acts as CFO at Vista, California-based Exagen, declined to comment for the article as well. All phone numbers listed on Pathway's site and elsewhere are forwarded directly to the "client specialist" line with no immediate response from the firm.  

Arne Astrup, head of the nutrition, exercise, and sports department at the University of Copenhagen, and who — according to Pathway's site — is a current SAB member, said that he has had no contact with Pathway since 2015. He noted that the firm has not responded to any of his emails in the last five years and therefore he assumed the company had shut down.

Tyler Hollmig, an associate professor in the department of internal medicine at University of Texas Dell Medical School and who is — according to Pathway's site — an SAB member, noted that he was unaware of the acquisition as well. He said that Michael Nova had recruited him while he was a resident at Stanford University Medical Center to help provide feedback on which skin diseases to include in the firm's tests.

"I helped him in terms of how we would think about genes affecting skin conditions, from anything like skin aging and sun damage to eczema," Hollmig explained. "I think the company wanted to take that information and try to come up with a way to safely test and analyze the genes involved in the skin and see if they could provide some insight."

Serving as a board member from 2014 to 2016, Hollmig noted that his "vesting term ended some time ago," and that he has not advised or been in contact with Pathway since 2016.

Nova noted that while Pathway has not "reached out to absolutely everybody that should be probably reached out to for this [acquisition] … I've been in contact with a couple of them already."

Past commercial issues

Pathway has dealt with multiple marketing, collaboration, and legal problems regarding its business practices since the firm was founded in 2008.

In May 2010, the US Food and Drug Administration sent a letter to Pathway, requesting additional clearance information regarding its Genetic Health Report, which the agency believed it had not cleared for marketing. Despite partnering with Pathway to sell its Saliva Collection Kit, Walgreens later backed out of the agreement the same week the firm received the letter. This led to a series of US congressional investigations of DTC genomics firms, including Pathway.

The FDA also sent Pathway Genomics a letter in 2015, noting that it had concerns about the firm's CancerIntercept Detect liquid biopsy assay, which it previously offered as a test that detects tumor DNA in high-risk but otherwise healthy patients. However, Pathway appears to no longer offer the test on its website.

In 2015, Pathway also agreed to pay about $4 million to settle a lawsuit with the US Department of Justice over allegations that it improperly paid kickbacks to clinicians in exchange for patient referrals.

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