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Color Gears Up to Enter COVID-19 Testing Space

NEW YORK – Color, the California-based genetic testing company known for providing hereditary risk testing for cancer and cardiovascular conditions, said on Tuesday that it will soon begin providing COVID-19 testing.

The company is opening a new lab in Burlingame dedicated to SARS-CoV-2 testing and is adapting its existing software infrastructure to make it easier for doctors to order testing and return results.  

A spokesperson for the company said that Color is currently operating an RT-qPCR assay with "established primer sets, extraction protocols, and instrumentation." The company is readying validation data and documentation for this test, but according to the spokesperson, "the FDA has asked that implementation of established protocols not be sent in through the [Emergency Use Authorization] system."

The US Food and Drug Administration in a recent update on its website said that it will not ask labs to submit an EUA if they have developed a COVID-19 based on the protocols of an EUA-authorized test, as long as they conduct a bridging study to validate their test to that EUA-authorized test. 

In the new lab, Color has a goal to perform 10,000 test daily and process results within 24 hours. Color will begin accepting external samples in the coming week and will scale up as staff and instrumentation comes online. "We expect to be at full capacity within weeks," the Color spokesperson said.

Color said it is also "validating higher-throughput COVID-19 testing techniques, including specialized laboratory protocols, automation techniques, and collection methods," in collaboration with the Broad Institute, Massachusetts Institute of Technology, Harvard University, and Weill Cornell Medicine. The company declined to provide further details on these efforts at this time.

Color said that its entry into COVID-19 testing is out of a desire to ease testing bottlenecks during the pandemic, and should not be interpreted to mean there is reduced demand for its commercial offerings. The company currently offers genetic testing for gauging the inherited risk for various cancers and cardiovascular conditions, and tests for genes associated with drug response.

"All of our partners know that Color continues to fully support their population health and genomics efforts, and our programs across the board are continuing," the company spokesperson said. "[COVID-19 testing] is a new effort that is completely complementary to our work and repurposes a lot of the same infrastructure and services."

However, some genetic testing companies are seeing reduced demand for genetic testing for hereditary cancer risk, and in general, for preventive services, as health systems and doctors are having to shift their resources and take extra precautions against infections during the public health crisis. Some companies in this space are hoping to limit negative impact on their businesses and on patient care, by sending saliva sample kits to patients' homes when physicians order cancer risk tests. Meanwhile, some doctors and counselors are providing more counseling over the phone when the test results are ready, since patients aren't able to come in for in-person services. 

Even if the genetic counseling portion can be done through the telephone, genetic counselors are currently struggling with whether patients should be tested and told they have a high genetic risk for cancer, since they likely won't be able to obtain mammograms or MRIs for some time. "There is this ethical question of should we be ordering testing for people where if we recommend increased screening they can't even get in for those procedures," said Meagan Farmer, genetic counseling business manager at My Gene Counsel, a health technology company that provides digital genetic counseling information.

Color has maintained that it has continued to see strong demand for its core commercial testing business. Since launching in 2015, the company has embraced a consumer-facing online model, where patients are able to learn their genetic test results online with the support of a genetic counselor over the phone. This model has proven valuable during the pandemic, according to the firm, as stay-at-home orders are being issued in cities throughout the US.

"Providers across the country are now working with us to provide clinical hereditary genetic testing to their patients at home and offering follow-ups and counseling through telemedicine," the Color spokesperson said, adding that the company's work with life sciences companies is also continuing as pharmaceutical companies are making adjustments to clinical trials. Some drugmakers, for the time being, have decided not to open new clinical trial sites and to limit in-person data collection within ongoing studies. "Our health system partners have also shifted to a digital [or] distributed model," the spokesperson said.

Color has a partnership with NorthShore University HealthSystem in Illinois, for example, to integrate pharmacogenetics and genetic risk testing for cancer and cardiovascular conditions in the primary care setting. That effort is still ongoing, though Peter Hulick, medical director of NorthShore's Center for Personalized Medicine, noted recently that "naturally, these are unprecedented times and we are following the [US] Centers for Disease Control and Prevention's recommendations for managing patient care." 

Meanwhile, in its efforts to start testing for COVID-19, Color said it is "hiring substantially" to staff up lab operations. "We've been in contact with some local companies, and we’ve had lots of people reach out to volunteer their time and their teams to support the effort," the spokesperson said.

Despite FDA loosening its regulations and allowing more labs to commercially launch COVID-19 tests, severe supply chain issues, including shortages in personnel, reagents, extraction kits, nasal swabs, have limited the ability of labs in hot zones to perform testing for all who need it.

Color is cognizant of these issues in entering this space. "We have been working hard at establishing a supply chain that does not use up already constrained supplies, in some cases working with manufacturers to create custom reagents, and taking on extra work to validate and qualify," the spokesperson said. "We are also working with specific partners to source, procure, and assemble swab kits for their collection sites."

Ultimately, in launching its testing service Color is hoping to ease the pressure the pandemic is placing on the healthcare system by adapting the software infrastructure it's using for the National Institutes of Health's All of Us Research Program and employers' wellness programs. The HIPAA-compliant platform would allow providers to order testing, facilitate return of results to patients and their doctors, and allow data to flow to state authorities for pandemic tracking.

"The platform we have can offload a huge amount of workload from healthcare professionals collecting samples, including upstream administrative tasks around eligibility and ordering, communicating results to patients, putting in place case management and positive triage protocols, and reporting cases systematically and rapidly to local and state health authorities," the spokesperson said. "It is absolutely critical that we move testing outside of healthcare facilities right now if we have any hopes of managing this crisis and protecting healthcare workers from additional exposure."