$CODX

Co-Diagnostics, Inc.

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No SEC Form 4 filings for $CODX in the last 30 days.

Med

Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test

Co-Diagnostics (Nasdaq: CODX) said it submitted a Dual 510(k) premarket notification with a concurrent CLIA Waiver by Application to the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument. The filing follows clinical studies of 1,400 symptomatic patients and analytical work across 27 studies and 10,000+ PCR runs. If granted, the CLIA waiver would enable decentralized point-of-care use; the platform is not yet for sale.

Co-Diagnostics, Inc. (CODX): Entry into a Material Definitive Agreement

Co-Diagnostics, Inc. (CODX) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. EX-4.1 3 ex4-1.htm EX-4.1 Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER T

CODX sentiment & insider activity

Over the past 7 days, alphai's AI scored 1 news story mentioning CODX (Co-Diagnostics, Inc.). Coverage has skewed bullish: 1 bullish, 0 neutral, and 0 bearish.

Recent CODX coverage spans regulation, corporate actions and technology.

What's driving CODX

  • Regulatory submission is a meaningful step toward commercialization in decentralized, CLIA-waived settings, but clearance timing and outcome remain uncertain.

    prnewswire.com · Aug 6, 2026

  • The filing signals a new equity-linked instrument, which can dilute and change near-term risk/reward for CODX holders.

    SEC EDGAR 8-K · Jul 31, 2026

  • The POC supports product differentiation for point-of-care Ebola diagnostics, but it is not yet a commercial or regulatory milestone.

    benzinga.com · Jul 28, 2026

  • The amendment increases flexibility for additional equity issuance, which can pressure near-term valuation via dilution risk.

    SEC EDGAR 8-K · Jul 27, 2026

  • Clinical-study initiation in India is a concrete execution milestone that can improve perceived progress toward commercialization, but it is not yet efficacy or regulatory outcome.

    benzinga.com · Jul 22, 2026

alphai scores every news story that mentions CODX with an AI model for sentiment and relevance, and aggregates insider trades from Co-Diagnostics, Inc.'s SEC EDGAR Form 4 filings. Figures refresh continuously.

News on $CODX

Score

Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test

Co-Diagnostics (Nasdaq: CODX) said it submitted a Dual 510(k) premarket notification with a concurrent CLIA Waiver by Application to the FDA for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro instrument. The filing follows clinical studies of 1,400 symptomatic patients and analytical work across 27 studies and 10,000+ PCR runs. If granted, the CLIA waiver would enable decentralized point-of-care use; the platform is not yet for sale.

$CODXMed

Co-Diagnostics, Inc. (CODX): Entry into a Material Definitive Agreement

Co-Diagnostics, Inc. (CODX) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. EX-4.1 3 ex4-1.htm EX-4.1 Exhibit 4.1 NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER T

$CODXLow

EXCLUSIVE: Co-Diagnostics Announces Successful Proof of Concept for Extraction-Free Ebola Test - Co-Diagn

Co-Diagnostics said it completed a proof-of-concept for an extraction-free Ebola test using its Co-Primers technology on the Co-Dx PCR Pro with diluted plasma. The work followed a C-CAMP request for 200 kits. The company is running analytical studies for Bundibugyo kits and developing a second-generation pan-Ebola assay. Shares rose 6.86% to $2.18 premarket.

$CODXMed

Co-Diagnostics, Inc. (CODX): Entry into a Material Definitive Agreement

Co-Diagnostics, Inc. (CODX) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. false 0001692415 0001692415 2026-07-27 2026-07-27 iso4217:USD xbrli:shares iso4217:USD xbrli:shares UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Repor

$CODXMed

EXCLUSIVE: Co-Diagnostics Marks New Milestone as India TB Test Clinical Studies Begin - Co-Diagnostics (N

Co-Diagnostics said it has begun clinical studies in India for its PCR Pro TB test platform, following shipments of PCR Pro instruments, MTB test kits, and sample preparation instruments to CoSara. The decentralized PCR platform is designed to return results in about 30 minutes. CoSara is deploying the CoSara-branded instrument in select labs. Co-Diagnostics shares were up 1.69% to $2.40 premarket.

$SPRCMedAI 8/10

Top Biotech Gainers: SPRC Deal Gets Nod, CODX Rallies, OTLK, AKTX, FTRE Drawing Investor Interest

SciSparc (SPRC) shares rose ~140% after its TSX Venture subsidiary received conditional approval to buy ~54% of private Israeli CliniQuantum for 56.6M NeuroThera shares (~$9.46M). Co-Diagnostics (CODX) gained ~53% for a third day amid Ebola PCR assay progress. Akari (AKTX) jumped ~38% on ASCO abstract acceptance and new KRAS-mutant synergy data; Outlook (OTLK) rose ~26% ahead of a June FDA resubmission.

Co-Diagnostics announces 1-for-30 reverse stock split By Investing.com

Co-Diagnostics, Inc. (NASDAQ:CODX) will effect a 1-for-30 reverse stock split on January 2, 2026, to meet Nasdaq's minimum bid price requirement. The company's stock has plummeted 69.44% year-to-date, and it reported significant revenue decline in Q3 2025. Despite financial challenges, Co-Diagnostics continues to expand its technology, recently securing an Australian patent for its Co-Dx PCR Pro platform and receiving a "Buy" rating from Maxim Group.

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