History in the Making: First Federally Recognized Tribal Society Submits At-Home Saliva COVID Test to FDA
As Native Americans Die of COVID-19 at Staggering Rate, Tribal-Owned Society Invests Massively in Science to Help Save Countless Lives
— John Cataldi
NEW YORK, UNITED STATES, June 22, 2022 /EINPresswire.com/ — Native Americans are dying of COVID-19 at a rate 2-3 times that of white Americans according to The Guardian. From the start of the pandemic through February 2021, one in 475 Native Americans has died from the first two waves of COVID, compared to one in 825 white Americans and one in 645 black Americans. The number of infections and hospitalizations is also increasing in indigenous populations, three times that of white Americans, according to the latest figures from the Centers for Disease Control and Prevention. Now, halfway through 2022, America is gearing up for the 5th wave, and with numbers like these, the stakes are high for Native America.
In a March 2022 interview in the United States, Dr. Loretta Christensen, Chief Medical Officer of the Indian Health Service, suggests that these poor COVID outcomes among Native Americans and Alaska Natives may be related to social needs, such as high rates of poverty, access to medical care, food insecurity and lack of access to running water. “We basically need to create effective infrastructure and sustainable infrastructure so that we can start building on that to improve all of these disparities,” Christensen says. “The result of this should be the improved health status of our Native American and Alaska Native population.”
The Blue Lake Rancheria Economic Development Corporation (BLREDC), a Blue Lake Rancheria Tribe-owned company located northwest of the town of Blue Lake in Humboldt County, California, understands the issues faced by Native American and American communities (especially rural communities) resemble each other. In 2021, tribal leaders appointed Clear Health Pass Holdings LLC as their agent and tribal representative in an effort to address one of the most pressing needs of Native Americans: access to testing, healthcare, and treatment. Needs that have only been made more urgent by the pandemic. Clear Health Pass ® CEO, co-manager of the Native American Venture Fund and former chief operating officer of the Seminole Tribe of Florida Inc., John Cataldi also understood the dangerous concerns for Native Americans and the rural communities in which they reside. After months of collaboration and development, the BLREDC with Clear Health Pass ® made history as the first federally recognized tribal society to submit an EUA application to the FDA. On May 29, 2022, they officially submitted their Clear Health Pass ® COVID-19 Multi-Variant ID Lollipop Test™.
The transition to saliva testing has been a long time coming. Multiple studies show that saliva testing poses a lower risk of COVID transmission to test administrators (caregivers, medical staff, parents, etc.) because there is less exposure to the patient’s breath compared to nasal swabs. . Additionally, numerous 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 shows up in saliva earlier than in nasal samples, particularly before symptoms appear. Study co-author Donald K. Milton, MD, DrPH, professor of occupational and environmental health at the Institute for Applied Environmental Health, University of Maryland School of Public Health, College Park, notes, “At first of infection, saliva was significantly more sensitive than middle turbinate nasal swabs.
Cataldi is passionate about providing resources to Native Americans and disadvantaged people: “COVID testing is a vast area of need in these communities, think about it if money is tight; are you going to prioritize purchasing groceries for your family or your health test?We all need access to more accessible, non-invasive testing, but these communities are the ones that need it the most.If you need a PCR test right now you will have to pay around $120-150 or more. It’s insane when profit comes before people. For us, there is only one mission, to save lives.
The BLREDC and Clear Health Pass ® are already working on expanding their business into a comprehensive biosciences portfolio. After the release of their saliva test kit for COVID, they will use their proprietary diagnostic platform for the early detection of many other medical conditions via non-invasive home saliva testing. Their platform will also include telehealth for the treatment of said conditions/diseases. Some examples are Parkinson’s disease, Alzheimer’s disease, gender-specific cancers (lymphoma, ovarian, colorectal, breast, pancreatic, and prostate), heart disease, diabetes, kidney disease, PTSD, and high risk of suicide . Each of these issues significantly affects Native Americans and Americans.
With the FDA submission behind them, Cataldi and his team are well aware that they still have a lot of work to do, but they all agree that their mission is a powerful motivator, and they are convinced that they bring something something on 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 Tribal Corporation, Section 17, whose tribal sovereignty authority is derived from the Indian Reorganization Act of 1934 (IRA), 25 USC § 477. BLREDC is a Tribal Corporation in wholly owned by the Blue Lake Rancheria Tribe, located on the traditional territory of the Wiyot people. The Wiyot, like the Yurok, traditionally lived along the Eel and Mad Rivers in northern California, going into nearby forests and grasslands.
Clear Health Pass ® – Paving the way to a healthy future.
Clear Health Pass Holdings LLC is a minority/veteran run organization in partnership as the tribal representative of the federally recognized Native American Tribes. Clear Health Pass ® was founded with one mission: to save lives today and every day. To do this, we offer a trifecta in biosciences: home diagnostic tests, telehealth/treatment and bioinformatics. Subject to FDA regulations and compliance.
The Clear Health Pass offering is governed by Rule 506(c) of Regulation D and is considered a “safe harbor” for the private offering exemption of Section 4(a)(2) of the Act on securities. To qualify for accredited investment status, you must be an accredited investor as defined by Section 2(15)(ii) of the Securities Act of 1933.
Clear Health Pass Holdings LLC
write to us here
Visit us on social media: