‍Highlights & Summary

The second month of the new year ushered in a lot of #LBxnews! February brought several collaborations, new trials, andlegal decisions.

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Clinical and Regulatory

In early February, Personalis obtained Medicare coverage for its NeXTPersonal MRD test as a recurrence surveillance tool for NSCLC patients, stage Ito III. The coverage is based on data generated through Personalis’ ongoingcollaboration with the TRACERx consortium which was recently published in thejournal Cell.

1 | Personalis Receives Medicare Coverage for NeXT Personal in Lung Cancer Surveillance Reimbursement Decision | Personalis

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Company Announcements & Product Launches

The past month saw NeoGenomics launch its RaDaR ST MRD test, expanding the oncology diagnostic service provider’s offerings. The new test is tumor-informed, using whole-exome sequencing to identify up to 48 patient-specific variants, and has been validated in breast and HPV-negative head and neck cancers to date. Merck and Mayo Clinic are collaborating for a new R&D project aimed at supporting AI-enabled drug discovery and precision medicine, starting with gastroenterology, dermatology, and neurology. Through the arrangement, Mayo will supply clinical and genomic data, as well as analytic tools, which Merck will use for its own AI development and R&D efforts. In Europe, the Joint Action on Personalized Cancer Medicine initiative debuted, aimed at supporting the implementation of personalized medicine across Europe.

1 | NeoGenomics Launches RaDaR ST, Expanding Molecular Residual Disease Testing Across Multiple Solid Tumor Types Product Launch | NeoGenomics

2 | Merck and Mayo Clinic Announce New Research and Development Collaboration to Support AI-Enabled Drug Discovery and Precision Medicine Partnership | Merck, Mayo Clinic

3 | Joint Action on Personalised Cancer Medicine Kicks Off Project Initiation | Joint Action on Personalised Cancer Medicine

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Clinical Trials & Study Results

Grail’s Galleri multi-cancer early detection (MCED) test missed its primary endpoint in a key study, causing a drop in share prices. The NHS trial evaluated 142,000 asymptomatic patients and did not show a statistically significant reduction in late-stage diagnoses, though Grail notes that a favorable trend was observed, and that the test did meaningfully decrease stage IV diagnoses versus standard of care alone. Guardant published results showing that its Reveal MRD test better predicts recurrence and overall survival than standard staging in a phase III trial of over 2,000 stage 3 CRC patients between surgery and adjuvant chemotherapy. Reveal identified patients at a 4-to-6-fold higher rate of recurrence or reduced survival. Natera announced positive results from its phase II SINERGY trial of MRD-guided treatment in metastatic head and neck cancer. Natera also presented data showing its Signatera MRD assay’s value in genitourinary malignancies, and launched EDEN, a prospective trial of its NIPT test for preeclampsia and other serious pregnancy complications. CareDx announced successful validation results for its AlloHeme AI-powered surveillance test for AML and MDS post-cell therapy. Myriad Genetics’ FirstGene prenatal screen test showed strong sensitivity and specificity across its various components in its own validation data.

1 | Grail’s multi-cancer early detection test misses study goal Study Results | Grail

2 | Largest Published Study of Molecular Residual Disease (MRD) in Stage III Colon Cancer Shows Guardant Reveal Blood Test More Precisely Identifies Risk of Recurrence After Surgery to Support Timely Treatment Decisions Study Results | Guardant Health

3 | Successful Readout of Prospective Phase 2 SINERGY Trial Supports SignateraTM MRD-Guided Treatment in Head and Neck Cancer Study Results | Natera

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M&A | VC | Private Equity | Legal

Guardant Health announced its acquisition of MetaSight for $59M upfront, with $90M attached to future successes. MetaSight’s technology uses mass spec multi-omics, and has shown promise in oncology as well as other indication areas. Insight Molecular Diagnostics agreed to sell 4.53M shares, a transaction which is expected to generate roughly $26M in part for the expansion of the company’s GraftAssure platform into heart transplant rejection testing. Syndex Bio raised $15.5M in an oversubscribed seed financing round and unveiled its mcPCR platform for DNA methylation analysis, described as “PCR for methylation.” The tech is expected to be useful for non-invasive and small-sample biopsies. Finally, Natera has accused a worker of stealing secrets by downloading confidential information prior to working for BillionToOne.

1 | Guardant buys MetaSight for $59M upfront to acquire blood test tech Acquisition | Guardant Health, MetaSight

2 | Insight Molecular Diagnostics prices $26M registered direct offering Fundraising | Insight Molecular Diagnostics

3 | Syndex Bio raises $15.5M seed and unveils mcPCR platform for DNA methylation analysis Fundraising | Syndex Bio

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Additional Sources

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Clinical Trials & Study Results

1 | CareDx Announces Clinical Validation Results for AlloHeme™, the First AI‑Powered NGS Surveillance Solution for AML and MDS Post‑Cell Therapy Study Results | CareDx

2 | FirstGene Study Demonstrates High Analytical Sensitivity and Specificity for Each Component of the Test Study Results | Myriad Genetics

3 | Signatera MRD Data at ASCO GU Highlights Potential Utility Across GU Cancers, Including for Bladder Preservation Conference Presentations | Natera

4 | Natera Launches EDEN Study on Early Risk Assessment for Preeclampsia and Adverse Pregnancy Outcomes Study Launch | Natera

5 | M-PACT leverages cell-free DNA methylomes to achieve robust classification of pediatric brain tumors Study Results | St. Jude’s Children’s Research Hospital, Hopp Children’s Cancer Center

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M&A | VC | Private Equity | Legal

1 | Natera Accuses Worker Who Went to Competitor of Stealing Secrets Lawsuit | Natera

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