Highlights & Summary

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End-of-the-year 2021 poised the Liquid Biopsy industry to have an explosive new year in 2022 with multiple medicare coverage designations, product launches, clinical trial progression, and promising funding rounds.

Clinical Adoption & Commercialization

1. GRAIL Announces Partnership with Alignment Health Plan as First Medicare Advantage Plan to Offer Galleri® Multi-Cancer Early Detection Blood Test
   Medicare Coverage | GRAIL
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2. ‍Quest Diagnostics Now Offers Biocept's Liquid Biopsy Test for Lung Cancer, Expanding its Menu of Advanced Cancer Diagnostics
   Commercial Partnership | Quest Diagnostics
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3. HelioLiver™, an Innovative Liquid Biopsy Test for the Early Detection of Liver Cancer, is Now Commercially Available
   Commercial Launch | HelioLiver

Company Announcements & Product Launches

1. Epic Sciences unveils DefineMBC™, a novel blood-based test designed to improve care for metastatic breast cancer patients
   Product Launch | Epic Sciences
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2. Personalis Launches NeXT Personal™, A Tumor-Informed Liquid Biopsy Assay for MRD and Recurrence Detection With Part-Per-Million Sensitivity
   Product Launch | Personalis
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3. Freenome, Siemens join forces to develop blood test for breast cancer
   ‍Partnership | Freenome
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4. Flagship Pioneering Launches Harbinger Health to Detect Early Cancer with a Simple, Bio-AI Based Blood Test
   Company Launch | Flagship Pioneering
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5. Twist Bioscience Launches Circulating Tumor DNA Reference Controls for Development of Liquid Biopsy Assays
   Product Launch | Twist Bioscience

Clinical Trials & Study Results

1. Foresight Diagnostics' PhasED-Seq ctDNA assay detects response to acalabrutinib as early as seven days in patients with aggressive B-cell lymphomas
   Clinical Trial Results | Foresight Diagnostics
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2. The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population
   Clinical Trial Launch | Grail

M&A, VC, & Private Equity

1. Labcorp Strengthens Oncology Leadership Position With the Addition of Personal Genome Diagnostics, a Provider of Comprehensive Liquid Biopsy and Tissue-Based Genomic Products and Services
   M&A | Labcorp, PGDx
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2. Exai Bio Secures $67.5 Million Series A Financing to Advance Next-Generation, RNA-Based Liquid Biopsy Platform for Early Cancer Detection
   ‍Funding | Exai Bio
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3. PetDx Raises $62 Million in Series B Financing to Scale Adoption of its Canine Multi-Cancer Early Detection Blood Test, OncoK9
   Funding | PetDx
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4. Rarecells, Inc. announces successful Series A funding, reaching $13 Million raised to develop Liquid Biopsy Early Cancer Detection Tests
   Funding | Rarecells, Inc.
   

Clinical Adoption & Commercialization

1 | GRAIL Announces Partnership with Alignment Health Plan as First Medicare Advantage Plan to Offer Galleri® Multi-Cancer Early Detection Blood Test

GRAIL has announced a partnership with Alignment Health Plan, a national Medicare Advantage health plan from Alignment Healthcare, to provide Medicare Advantage members access to Galleri. Alignment Health Plan is the first Medicare Advantage plan to offer the Galleri test as a complement to recommended single cancer screenings. New and existing Alignment Health Plan members who enroll in select HMO and PPO plans in California and North Carolina will have access to Galleri beginning Jan. 1, 2022 by prescription only. View Source

2 | Quest Diagnostics Now Offers Biocept's Liquid Biopsy Test for Lung Cancer, Expanding its Menu of Advanced Cancer Diagnostics

In the United States, physicians can order the Target Selector NGS Lung Panel test from Quest Diagnostics. This liquid biopsy test helps physicians identify targeted therapies for those with Non-Small Cell Lung Cancer (NSCLC). In addition, it can help monitor the impact of selected treatments on the patients. The test itself mainly consists of clinically actionable markers informed based on NCCN guidelines or FDA-approved treatments. View Source

3 | HelioLiver™, an Innovative Liquid Biopsy Test for the Early Detection of Liver Cancer, is Now Commercially Available

Helio Health and its partner Fulgent Genetics, Inc, announced the commercial launch of HelioLiver™, a multi-analyte blood test which uses serum protein markers and cell free DNA (cfDNA) methylation patterns to detect early-stage hepatocellular carcinoma (HCC). Helio Health presented data at The Liver Meeting® 2021 showing HelioLiver’s impressive performance data with a 91% specificity and 76% sensitivity in detecting early-stage HCC. “Leveraging our extensive commercial infrastructure, we are well-positioned to deliver an easy ordering experience for providers,” said Brandon Perthuis, Chief Commercial Officer, Fulgent Genetics. View Source

Company Announcements & Product Launches

1 | Epic Sciences unveils DefineMBC™, a novel blood-based test designed to improve care for metastatic breast cancer patients

Epic Sciences, Inc. announces DefineMBC — a novel liquid biopsy test (LBx) that combines several multi-analyte assay methods to perform comprehensive metastatic breast cancer (MBC) profiling when tissue biopsy results are not available due to the impact of targeted therapies, ongoing clonal variations, and other known cancer dynamics. DefineMBC performs whole-genome single-cell sequencing of circulating tumor cells (CTCs) for the quantification of ER and HER2 protein copy number variation (CNV) accompanied by immunofluorescent staining and machine learning (ML) image analysis. The assay further analyzes cell-free DNA (cfDNA) of 56 genes through next-generation sequencing (NGS) for the detection of genomic alterations, specifically single nucleotide variants (SNVs), fusions, copy number variation (CNV), microsatellite instability (MSI), and tumor mutational burden (TMB); expanded coverage of up to 500 genes is available for research and biopharma trial settings. View Source

2 | Personalis Launches NeXT Personal™, A Tumor-Informed Liquid Biopsy Assay for MRD and Recurrence Detection With Part-Per-Million Sensitivity

Personalis, Inc. announced the launch of NeXT Personal, a tumor-informed liquid biopsy assay designed to detect and quantify molecular residual disease (MRD) and recurrence in patients previously diagnosed with cancer. Personalis, Inc. plans to launch NeXT Personal as a clinical test in 2022 targeted towards biopharma partners and clinical collaborators. NeXT Personal uses whole genome next-generation sequencing (NGS) of a patient’s tumor to identify up to 1,800 somatic variants, which then creates a personalized liquid biopsy (LBx) panel for each patient to be applied to circulating tumor DNA (ctDNA) collected from a corresponding blood sample. The aggregation of signals across these sequences using proprietary algorithms enables part-per-million sensitivity and quantifies clinically relevant mutations that may be used in the future to help guide therapy such as targetable cancer mutations, drug resistance mutations, and new variants. View Source

3 | Freenome, Siemens join forces to develop blood test for breast cancer

Freenome and Siemens Healthineers have announced a partnership to develop a liquid biopsy test for improved early detection of breast cancer. Imaging, clinical, and molecular data will be used to locate new biomarkers that are detectable in a standard blood draw and indicate breast cancer at an early stage. The collaboration will focus on augmenting current imaging techniques developed by Siemens such as mammograms and breast MRIs with Freenome's AI software, which analyzes complementary blood biomarker data sets. View Source

4 | Flagship Pioneering Launches Harbinger Health to Detect Early Cancer with a Simple, Bio-AI Based Blood Test

Flagship Pioneering announced the launch of Harbinger Health, a Bio-AI bioplatform company developing a liquid biopsy (LBx) test for early cancer detection through their proprietary HarbingerHx™ platform. HarbingerHx™ is the product of three years of research and development within Flagship Labs and works by combining insights into specific biological events with Artificial Intelligence (AI) and Machine Learning (ML) analysis. Stephen Hahn, M.D., the 24th Commissioner of the United States Food & Drug Administration, and former Chief Medical Executive of MD Anderson Cancer Center will lead the company as CEO of Harbinger Health. View Source

5 | Twist Bioscience Launches Circulating Tumor DNA Reference Controls for Development of Liquid Biopsy Assays

Following-up on Twist’s synthetic SARS-CoV-2 positive controls, the company announced the launch of the cfDNA Pan-cancer Reference Standards. The reference standards consist of synthetic circulating-tumor DNA (ctDNA) of over 400 variants, including 140 clinically relevant variants, SNVs, indels, fusions, and structural variants to be used in ctDNA-based assays in liquid biopsy (LBx) testing across the cancer monitoring continuum. The synthetic standards mimic human-derived cdFNA with improved stability and can be used to establish analytical limits of detection (LoD) as well as NGS assay workflow fidelity. Synthetic controls will play an increasingly important role in cancer diagnostics where patient biopsies are difficult to obtain and degrade in quality over time and through preservation methods as opposed to rapid and reproducible synthetic alternatives. View Source

Clinical Trials & Study Results

1 | Foresight Diagnostics' PhasED-Seq ctDNA assay detects response to acalabrutinib as early as seven days in patients with aggressive B-cell lymphomas

ForeSight Diagnostics has announced initial results on a phase 2 clinical trial for acalabrutinib, a lymphoma drug. To gather results, ForeSight's ctDNA detection and MRD monitoring assay, known as PhasED-Seq (Phased variant Enrichment and Detection Sequencing), was used. The ctDNA levels and PhasED-Seq correlated well with CT imaging and tumor mutational burden (TMB) changes. Nearly half of patients (46%) responded to acalabrutinib based on CT imaging, with the PhasED-Seq strongly predictive of response in the patients. Prior to changes shown with traditional CT monitoring, one patient showed a 20-fold stop in ctDNA, demonstrating that PhasED-Seq could help predict treatment responses with greater sensitivity than these traditional methods. View Source

2 | The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population

Grail launched its latest clinical trial, PATHFINDER 2: a prospective, multi-center interventional study of the GRAIL multi-cancer early detection test with return of test results for participants enrolled through healthcare systems in North America. The study will enroll approximately 10,000 participants as defined by eligibility criteria over an anticipated enrollment period of approximately 10 months at up to 30 clinical institutions within North America. Participants will be actively followed for approximately 3 years from the date of their enrollment. The purpose of this study is to evaluate the safety and performance of the GRAIL multi-cancer early detection test in a population of individuals who are eligible for guideline-recommended cancer screening. In cases with a "cancer signal detected" test result, participants will undergo diagnostic procedures based on the test returned cancer signal origin(s) to determine if they have cancer. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test. View Source

M&A, VC, & Private Equity

1 | Labcorp Strengthens Oncology Leadership Position With the Addition of Personal Genome Diagnostics, a Provider of Comprehensive Liquid Biopsy and Tissue-Based Genomic Products and Services

The life sciences company Labcorp has acquired Personal Genome Diagnostics (PGDx). This acquisition may accelerate Labcorp's LBx offerings as well as expand their NGS-based capabilities given the kitted solutions PGDx already offers. Due to their global reach, Labcorp can now aim to expand PGDx products into the reach of pharmaceutical companies worldwide. A significant offering of PGDx is their pan-solid cancer diagnostic kit that covers over 500 genes, which is the only kit of its kind that is FDA approved. The agreement will cost Labcorp $450 million, and possibly up to $675 million based on achievements that the company may complete in coming years. View Source

2 | Exai Bio Secures $67.5 Million Series A Financing to Advance Next-Generation, RNA-Based Liquid Biopsy Platform for Early Cancer Detection

Exai Bio raised $67.5 million in Series A funding for development of its RNA-based liquid biopsy platform for early cancer detection. Exai Bio's novel platform measures cell-free RNA profiles - specifically, orphan non-coding RNA (oncRNA), which are small RNA sequences abundant in tumors and not seen in normal tissue. Exai Bio is using advanced AI and machine learning algorithms to analyze these profiles and is the first company founded to explore the use of oncRNA in early cancer detection. View Source

3 | PetDx Raises $62 Million in Series B Financing to Scale Adoption of its Canine Multi-Cancer Early Detection Blood Test, OncoK9

PetDx completed a $62 million Series B financing led by Longview Asset Management, bringing its total funding to date to $72 million. The company recently launched its OncoK9®, the first cancer screening program for dogs, which is a multi-cancer (30 canine cancer types) early detection (MCED) liquid biopsy (LBx) test that screens for tumor cell free DNA (cfDNA) using Illumina next-generation sequencing (NGS) technology with sensitivity and specificity similar to human MCED tests. OncoK9 was clinically validated in the CANDiD (CANcer Detection in Dogs) study, which utilized prospective samples from 1,000 dogs in more than 40 clinical sites on four continents. The test is available at veterinary clinics across the US and the funding will help strengthen strategic distribution partnerships and increase testing in PetDx’s central laboratory in San Diego. View Source

4 | Rarecells, Inc. announces successful Series A funding, reaching $13 Million raised to develop Liquid Biopsy Early Cancer Detection Tests

Rarecells, Inc. announced a Series A funding total of $13 million that will help support the start of laboratory and clinical operations in the United States, including the development of liquid biopsy early cancer detection tests. Rarecells, Inc.'s pipeline of products includes two early detection mono-cancer tests (for prostate cancer and acute myeloid leukemia) and an early detection multi-cancer test using a standard blood draw. View Source

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Headlines are curated by Alex Amram, Hannah Glazier, and Amal Thommil.