Mammoth Biosciences is a San Francisco-based company founded on June 1, 2017, that develops diagnostic and genome editing therapeutics based on CRISPR technology. When Mammoth was founded, it focused on diagnostics but later moved into therapeutics. Mammoth Biosciences uses CRISPR technology to develop bio-sensing technologies for diagnostics in industries such as healthcare, agriculture, manufacturing, and forensics. The technology being used by Mammoth Bioscience theoretically allows for the detection of any biomarker and/or disease that contains either RNA and/or DNA. CRISPR proteins Cas12 (targeting double-stranded DNA), Cas13 (targeting single-stranded RNA), and Cas14 (targeting ssDNA) are used in Mammoth’s diagnostics platform. Guide RNA (gRNA) is used to program the system to detect desired nucleic acid sequences, and Cas proteins cleave reporter molecules, which signal when gRNA matches the target sequence.
In genome editing therapeutics, Mammoth is focusing on Cas proteins in Cas14 and Casɸ families, which are smaller compared with Cas9 and may help overcome barriers to the delivery of gene editing therapeutics to many cell types in the body because they can fit into adeno-associated virus. Mammoth’s research pipeline includes epigenetic editing and base editing as well as the detection of single nucleotide polymorphisms (SNPs), genetic variations that can be linked to disease.
Mammoth Biosciences uses technology licensed from UC Berkley and has created a credit card strip capable of delivering health diagnostics at the point of care in hospital and home settings. Their diagnostic strip works by dropping the desired fluid sample onto the strip and waiting for panels on the strip to change color, indicating the test is complete. The CRISPR technology is embedded within the strip, and if or when the desired reaction takes place, a colored molecule is released, called a reporter molecule. Different reporter molecules can be present and eventually build up into colors that can be seen with the naked eye. The user then takes a photo of the strip after the reaction is complete (taking approximately thirty minutes) using a smartphone application developed by Mammoth Biosciences. Users can see the results of their strip test using the app.
Mammoth Biosciences partnered with UC San Francisco to develop a diagnostic test to identify people infected with coronavirus, SARS-CoV-2 (previously called 2019-nCoV). The coronavirus strain, identified December 31, 2019, was responsible for an outbreak of the disease called COVID-19 that began in Wuhan, China in December, 2019, and was declared a pandemic by the World Health Organization (WHO) in March 2020. Early in the pandemic, testing samples were shipped to the Centers for Disease Control and Prevention, where the test could take six or more hours to complete. The test being developed by Mammoth Biosciences was expected to take one or two hours and be completed at the doctor’s office. Mammoth's test involved a nasal swab placed in a tube with the CRISPR-Cas system and using a color-changing strip of paper to check for a positive or negative test result. Their test, using CRISPR-Cas12a-based lateral flow assay and RT-LAMP technology with results in less than forty minutes, was validated in patient respiratory swab RNA extracts, and results were published in April 2020.
Mammoth’s DETECTR BOOST SARS-CoV-2 Reagent Kit for diagnosing SARS-CoV-2 was authorized for emergency use by the FDA in January 2022. Mammoth decided not to commercialize the diagnostic kit, and at the company’s request, the FDA revoked the emergency use authorization on December 15, 2022.
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