NEWS: Helix Scores a Double Win in San Diego County This Month. Latest Achievement is $33 Million-Plus Award from NIH for COVID-19 Testing
A startup that recently partnered with SD county to provide thousands of COVID-19 tests per day has been awarded more than $33 million in funding from the NIH to scale up its testing capacity even more.
Helix, a genomics research company, which pivoted to do the testing (see related article here), announced the news today. The company has now been designated as a “mega-lab” – one which can increase testing capacity to 100,000 to 250,000 tests per day.
The company said in a press release that it will use the NIH funds to support rapid scaling of all aspects of its COVID-19 infrastructure and operations, with a goal of reaching a capacity of 100,000 tests per day by the Fall, with the potential to scale even further.
Marc Stapley is the CEO of Helix, with HQ in San Mateo.
Helix’s test system includes a non-invasive collection kit, processing of samples in Helix’s certified and accredited laboratory in SD and next-day turnaround time, as well as provided the results to the ordering healthcare professional, the tested individual, and public health agencies, as necessary.
To support the rapid expansion of its testing capabilities and capacity, Helix has filed an additional EUA (emergency use authorization) with the FDA for its COVID-19 NGS Test, which it claims is a more sensitive test, based on next-gen sequencing tech.
This test, based on the “SwabSeq” protocol developed by Octant, continues to be iterated through a broad community effort involving academic and industry collaborators.
“This is an exciting milestone,” said Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering and leader of RADx Tech, one of four components of the NIH RADx initiative, which supplied the funding to Helix.
OCSN was the first to profile Tromberg’s ascent from the Beckman Laser Institute in OC to the NIH. See article on him here.
“It will help increase U.S. testing capacity exponentially,” Tromberg continued. “Game-changing technologies emerging from our RADx pipeline will inform public health measures to stop the spread of the virus and leave us better equipped to address future pathogens and other diseases.”
Helix’s original COVID-19 test has been authorized by FDA under an EUA for use by authorized laboratories. This test has not been FDA cleared or approved.
Genomic Research Continues
While the company is expanding the resources it’s devoting to COVID-19 testing, it continues to operate its population genomics business. Many of its partners are actively enrolling participants in studies via digital enrollment and continuing to drive innovation in genomics. Here is some current research the company is doing:
Impact of population genetic screening: Based on its work with Renown Health on the Healthy Nevada Project, it recently published a study in Nature Medicine titled “Population genetic screening efficiently identifies carriers of autosomal dominant diseases” which shows that broad population genetic screening has the potential to identify individuals at risk for highly actionable, genetic conditions who would otherwise be missed in current medical practice
Assessing the impact of frequent testing on infection rates: Using an SIR (Susceptible, Infected, and Removed) model, we show that testing at regular intervals has potential to dramatically lower the infection rate in a population, even in a scenario where there is widespread community transmission. The white paper is available here.
Evaluating the viability of saliva as a specimen type: In a study with 88 patients in the community setting done in collaboration with Renown Health and UC San Diego, we found saliva-based COVID-19 testing was 30% less sensitive than nasopharyngeal swabs, making it an unsuitable specimen type for broad community-based testing. The research is available as a preprint on medRxiv and summarized in a blog post.
Large-scale user research: We surveyed our large pre-sequenced and consented research participants about possible COVID-19 exposure, symptoms, and treatment to better understand genetic susceptibility to COVID-19. We’re continuing to collect additional data, but more information about the work can be found here and preliminary insights have been reported here – including the identification of a potential new and highly differentiating symptom: sensitive skin.