History in the Making: The First Federally Recognized Tribal Corporation Submits At-Home Saliva COVID Test To The FDA

With Native Americans dying of COVID-19 at shocking rates, one Tribally Owned Corporation Is Investing heavily in science to Help Save Countless Lives

 

Indigenous Americans are dying from COVID-19 at 2-3 times the rate of white Americans according to The Guardian. Since the onset of the pandemic through February 2021, one in every 475 Native Americans has died from the first two waves of COVID, compared with one in every 825 white Americans and one in every 645 Black Americans. Infection and hospitalization numbers are also increased in Native populations, three times greater than in white Americans, according to the latest figures from The Centers for Disease Control and Prevention. Now, midway through 2022, America prepares for the 5th wave, and with numbers like these, the stakes are high for Native America.

In a U.S. News Interview done in March 2022, Dr. Loretta Christensen, Chief Medical Officer for the Indian Health Service, suggests these poor COVID outcomes among American Indian and Alaska Native individuals may be tied to social needs, such as high rates of poverty, access to medical care, food insecurity and a lack of access to running water. “We basically need to create an effective infrastructure and a sustainable infrastructure so that we can start to build on that to improve all of these disparities,” Christensen says. “The result of that should be improved health status of our American Indian and Alaska Native population.”

The Blue Lake Rancheria Economic Development Corporation (BLREDC), a wholly-owned corporation of the Blue Lake Rancheria Tribe located northwest of the city of Blue Lake in Humboldt County, CA, understood the issues facing both Native American and American Communities (especialy rural communities) alike. In 2021, tribal leadership assigned Clear Health Pass Holdings LLC as its tribal agent and representative with the intent to fix one of the most pressing Native American needs: access to testing, healthcare, and treatment. Needs that were only made more urgent by the pandemic. Clear Health Pass ® CEO, Co-Managing Partner of the Native American Venture Fund, and the previous COO of the Seminole Tribe of Florida Inc., John Cataldi also understood the dangerous concerns for Native America and the rural communities in which they reside. After months of collaboration and development, the BLREDC with Clear Health Pass ® made history by being the first federally recognized tribal corporation to submit an application for EUA to the FDA. On May 29th, 2022, they officially submitted their Clear Health Pass ® COVID-19 Multi-Variant ID Lollipop Test ™.

The transition to saliva tests has been a long time coming. Multiple studies show that saliva tests have a lower risk of COVID transmission to test administrators (caretakers, medical personnel, parents, etc.) as there is less exposure to the patient’s respiration compared to nasal swabs. In addition, many studies have shown data that saliva PCR tests more accurately identify COVID-19 than nasal swabs. One such study published in March 2022 in Microbiology Spectrum, a journal of the American Society for Microbiology, shows that the virus presents in saliva sooner than in nasal specimens, especially before the onset of symptoms. Study coauthor Donald K. Milton, M.D., DrPH, a professor of occupational and environmental health at the Institute for Applied Environmental Health, University of Maryland School of Public Health, College Park, notes: “Early in the course of infection, saliva was significantly more sensitive than mid-turbinate nasal swabs.”

Cataldi is passionate about providing resources for Native America and the underprivileged: “COVID testing is a vast area of need in these communities, Think about it if money is tight; are you going to prioritize buying groceries for your family or health test? We all need access to more accessible, non-invasive testing, but these communities are the ones who need it the most. If you need a PCR test right now, you’re going to be charged around $120-$150 or more. It is insane when profit comes before people. For us, there is only one mission, saving lives.”

The BLREDC and Clear Health Pass ® are already working on expanding their venture into a complete bioscience portfolio. Following the release of their Saliva Test Kit for COVID, they will utilize their proprietary diagnostic platform for early detection of many other medical conditions via non-invasive, at-home saliva tests. Their platform will also include telehealth for the treatment of said conditions/diseases. Just a few examples are Parkinson’s, Alzheimer’s, gender-specific cancers (lymphoma, ovarian, colorectal, breast, pancreatic, and prostate), heart disease, diabetes, kidney disease, PTSD, and elevated risk of suicide. Each of these issues significantly affect Native America and Americans alike.

With the FDA submission behind them, Cataldi and his team are well aware they still have a lot of work ahead, but they all agree their mission is a powerful motivator, and they are confident they are bringing something to the market that has the potential to save millions of lives.

About Blue Lake Rancheria Economic Development Corporation
Blue Lake Rancheria Economic Development Corporation (BLREDC), a Federal, Section 17, Tribal Corporation, whose tribal sovereignty authority is derived from the Indian Reorganization Act of 1934 (IRA), 25 U.S.C. § 477. BLREDC is a wholly-owned tribal corporation of the Blue Lake Rancheria tribe, located within the traditional territory of the Wiyot people. The Wiyot, like the Yurok, traditionally lived along with the Eel and Mad Rivers in northern California, ranging into neighboring forests and prairies.

About
Clear Health Pass ® – Clearing the way for a healthy tomorrow.
Clear Health Pass Holdings LLC is a minority/veteran-operated organization in partnership as tribal representative of federally recognized Native American Tribes. Clear Health Pass ® was founded with one mission: To save lives today and every day. We do this by providing a bio-science trifecta: at-home diagnostic testing, telehealth/treatment, and bioinformatics. Subject to FDA Regulations and Compliance.
Clear Health Pass’s offering is under Rule 506(c) of Regulation D and is regarded as a “safe harbor” for the private offering exemption of Section 4(a)(2) of the Securities Act. To be eligible to receive qualified investment status, you must be an accredited investor as defined by Section 2(15)(ii) of the Securities Act of 1933.