Organization	6 Months Ended
Jun. 30, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Organization	Note 1. Organization Description of Business Lucira Health, Inc. (the “Company”) was incorporated under the laws of the state of Delaware on February 20, 2013 under the name DiAssess Inc. The Company changed its name to Lucira Health, Inc. in January 2020. The Company is located in Emeryville, California. The Company is a medical technology company with a mission to bring central laboratory quality testing for infectious diseases in the home and point of care settings. The Company has developed a testing platform that produces high-complexity-laboratory-accurate molecular testing in a single-use and user-friendly test kit that is powered by two AA batteries and fits in the palm of a hand. The Company’s initial focus is within respiratory diseases, and initially for COVID-19 and influenza Types A and B indications. On November 17, 2020, the Company received an Emergency Use Authorization (“EUA”) from the Food and Drug Administration (“FDA”) for (1) prescription at-home use with self-collected nasal swab specimens in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider and (2) use at the point-of-care (“POC”), with self-collected nasal swab specimens in individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider at the POC. People who are suspected of COVID-19 are those who are either symptomatic or are thought to have been exposed to COVID-19. On April 9, 2021, the Company received its first FDA EUA authorization for over-the-counter (“OTC”) non-prescription use among symptomatic and asymptomatic individuals aged 14 and older (with self-collection) and children aged two to 13 (with parent collection). On May 6, 2022, the Company received the Conformité Européenne Mark (“CE Mark”) for professional use for both its COVID-19 and combination COVID-19 influenza test kits, clearing them for sale and distribution in the European Union. On May 11, 2022, the Company submitted its request for EUA authorization from the FDA for prescription at-home use of its combination COVID-19 and influenza test, for those individuals with suspected COVID-19 or influenza. This request for EUA authorization from the FDA was revised and resubmitted to the FDA to include over-the-counter use of its combination test kit, in addition to authorization for prescription at-home use. On May 31, 2022, Health Canada approved our request to extend our current 12-month shelf life to 18 months for our COVID-19 test kit. On June 8, 2022, the Company received approval for full exemption by the New Zealand Ministry of Health for its LUCIRA CHECK IT COVID-19 Test Kit and its LUCIRA COVID-19 All-In-One Test Kit for self-test. On June 10, 2022, the Company submitted a revised EUA application to the FDA. On June 14, 2022, the Company received registration approval in the United Kingdom from the Medical and Healthcare Products Regulatory Agency for both its COVID-19 and combination test kit in the United Kingdom and New Zealand. On July 8, 2022, the Company submitted its de novo application to the FDA or its COVID-19 test kit. Liquidity and Going Concern Net loss for the six months ended June 30, 2022 was $8.6 million, comprised of net income for the three months ended March 31, 2022 of $13.1 million and net loss of $21.7 million for the three months ended June 30, 2022. Prior to the three months ended March 31, 2022, since its inception, the Company has incurred recurring losses and negative cash flows from operating activities. The Company may continue to incur additional losses in future periods and the net losses that the Company incurs may fluctuate significantly from period to period due to the seasonality of its product portfolio. As of June 30, 2022, the Company had $75.0 million in cash and cash equivalents and an accumulated deficit of $137.1 million. The Company generated net sales of $26.1 million and $116.6 million in the three and six months ended June 30, 2022, respectively. On February 4, 2022, the Company closed a debt financing of up to $80.0 million. The first tranche of $30.0 million was funded upon close. See Note 10. Term Loans. The Company believes that cash and cash equivalents as of June 30, 2022, anticipated cash flows from operations, and available cash advances under the Term Loans, contingent upon the Company's achievement of certain revenue milestones as defined in the Loan Agreement (see Note 10. Term Loans) will be sufficient to fund its planned operations, including servicing the Term Loans, operating lease payments, and capital expenditures, for a period of at least 12 months from the date of the issuance of the accompanying condensed financial statements. The ability to continue as a going concern is dependent upon the Company generating revenue and profit in the future and/or upon obtaining necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due. The Company may raise additional capital through the issuance of equity securities, debt securities, or other sources of capital in order to further implement its business plan. However, if other financing is not available when needed and at adequate levels, the Company will need to reevaluate its operating plan and may be required to delay the development of new test kits, or curtail current operations and business plans.

Organization

6 Months Ended

Jun. 30, 2022

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Note 1. Organization

Description of Business

Lucira Health, Inc. (the “Company”) was incorporated under the laws of the state of Delaware on February 20, 2013 under the name DiAssess Inc. The Company changed its name to Lucira Health, Inc. in January 2020. The Company is located in Emeryville, California.

The Company is a medical technology company with a mission to bring central laboratory quality testing for infectious diseases in the home and point of care settings. The Company has developed a testing platform that produces high-complexity-laboratory-accurate molecular testing in a single-use and user-friendly test kit that is powered by two AA batteries and fits in the palm of a hand. The Company’s initial focus is within respiratory diseases, and initially for COVID-19 and influenza Types A and B indications.

On November 17, 2020, the Company received an Emergency Use Authorization (“EUA”) from the Food and Drug Administration (“FDA”) for (1) prescription at-home use with self-collected nasal swab specimens in individuals aged 14 and older who are suspected of COVID-19 by their healthcare provider and (2) use at the point-of-care (“POC”), with self-collected nasal swab specimens in individuals aged 14 and older, and in individuals aged 13 and under when the specimen is collected by a healthcare provider at the POC. People who are suspected of COVID-19 are those who are either symptomatic or are thought to have been exposed to COVID-19. On April 9, 2021, the Company received its first FDA EUA authorization for over-the-counter (“OTC”) non-prescription use among symptomatic and asymptomatic individuals aged 14 and older (with self-collection) and children aged two to 13 (with parent collection). On May 6, 2022, the Company received the Conformité Européenne Mark (“CE Mark”) for professional use for both its COVID-19 and combination COVID-19 influenza test kits, clearing them for sale and distribution in the European Union. On May 11, 2022, the Company submitted its request for EUA authorization from the FDA for prescription at-home use of its combination COVID-19 and influenza test, for those individuals with suspected COVID-19 or influenza. This request for EUA authorization from the FDA was revised and resubmitted to the FDA to include over-the-counter use of its combination test kit, in addition to authorization for prescription at-home use. On May 31, 2022, Health Canada approved our request to extend our current 12-month shelf life to 18 months for our COVID-19 test kit. On June 8, 2022, the Company received approval for full exemption by the New Zealand Ministry of Health for its LUCIRA CHECK IT COVID-19 Test Kit and its LUCIRA COVID-19 All-In-One Test Kit for self-test. On June 10, 2022, the Company submitted a revised EUA application to the FDA. On June 14, 2022, the Company received registration approval in the United Kingdom from the Medical and Healthcare Products Regulatory Agency for both its COVID-19 and combination test kit in the United Kingdom and New Zealand. On July 8, 2022, the Company submitted its de novo application to the FDA or its COVID-19 test kit.

Liquidity and Going Concern

Net loss for the six months ended June 30, 2022 was $8.6 million, comprised of net income for the three months ended March 31, 2022 of $13.1 million and net loss of $21.7 million for the three months ended June 30, 2022. Prior to the three months ended March 31, 2022, since its inception, the Company has incurred recurring losses and negative cash flows from operating activities. The Company may continue to incur additional losses in future periods and the net losses that the Company incurs may fluctuate significantly from period to period due to the seasonality of its product portfolio. As of June 30, 2022, the Company had $75.0 million in cash and cash equivalents and an accumulated deficit of $137.1 million. The Company generated net sales of $26.1 million and $116.6 million in the three and six months ended June 30, 2022, respectively. On February 4, 2022, the Company closed a debt financing of up to $80.0 million. The first tranche of $30.0 million was funded upon close. See Note 10. Term Loans.

The Company believes that cash and cash equivalents as of June 30, 2022, anticipated cash flows from operations, and available cash advances under the Term Loans, contingent upon the Company's achievement of certain revenue milestones as defined in the Loan Agreement (see Note 10. Term Loans) will be sufficient to fund its planned operations, including servicing the Term Loans, operating lease payments, and capital expenditures, for a period of at least 12 months from the date of the issuance of the accompanying condensed financial statements.

The ability to continue as a going concern is dependent upon the Company generating revenue and profit in the future and/or upon obtaining necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due. The Company may raise additional capital through the issuance of equity securities, debt securities, or other sources of capital in order to further implement its business plan. However, if other financing is not available when needed and at adequate levels, the Company will need to reevaluate its operating plan and may be required to delay the development of new test kits, or curtail current operations and business plans.