On August 4, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the second quarter ended June 30, 2022 (Press release, Repare Therapeutics, AUG 4, 2022, View Source [SID1234617611]).

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"The worldwide license and collaboration agreement we signed with Roche this quarter represents a major step in the broad global development and commercialization of camonsertib, and validates our strategy to build value into our pipeline by developing innovative drugs that target specific synthetic-lethal genomic alterations as we recently demonstrated at AACR (Free AACR Whitepaper)," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "We have made substantial progress in our Phase 1 clinical trial evaluating RP-6306 as a monotherapy and in combination with camonsertib and two chemotherapy agents for the treatment of molecularly selected advanced solid tumors. We have also advanced our polymerase theta inhibitor, RP-2119, to IND-enabling studies. We look forward to providing an initial clinical data readout from the Phase 1 RP-6306 trial in the first half of 2023."

Second Quarter 2022 Review and Operational Updates:

Announced closing of its worldwide license and collaboration agreement with Roche for the development and commercialization of camonsertib (also known as RP-3500), a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of tumors with specific synthetic-lethal genomic alterations.
In connection with the closing of the collaboration agreement, Repare received an upfront payment of $125 million from Roche in July 2022.
Under the collaboration, Roche will assume the development of camonsertib with the potential to expand development into additional tumor indications and multiple combination studies.
In addition to the $125 million upfront payment, Repare is eligible to receive up to $1.172 billion in potential clinical, regulatory, commercial and sales milestones, including up to $55 million in potential near-term payments, and royalties on global net sales ranging from high-single-digits to high-teens. The collaboration also provides Repare with the ability to opt-in to a 50/50 U.S. co-development and profit share arrangement, including participation in U.S. co-promotion if U.S. regulatory approval is received. If Repare chooses to exercise its co-development and profit share option, it will continue to be eligible to receive certain clinical, regulatory, commercial and sales milestone payments, in addition to full ex-U.S. royalties.
Advanced RP-6306, a first-in-class, oral PKMYT1 inhibitor as a monotherapy and in combinations
Phase 1 clinical trials are currently evaluating RP-6306 as a monotherapy (MYTHIC) as well as in combination with gemcitabine (MAGNETIC) for the treatment of molecularly selected advanced solid tumors. In January 2022, the Company initiated an additional Phase 1 clinical trial of RP-6306 in combination with FOLFIRI (MINOTAUR), also for the treatment of molecularly selected advanced solid tumors.
In May 2022, Repare initiated patient recruitment in a new arm of the Phase 1 MYTHIC clinical trial, which is designed to evaluate the safety and tolerability of RP-6306 in combination with camonsertib in patients with advanced solid tumors.
Initial Phase 1 clinical data readout for RP-6306 is now expected in the first half of 2023 for monotherapy (previously expected in the second half 2022) and potentially for combination therapies, due to disruptions in global trial site activation and enrollment resulting from the ongoing COVID-19 pandemic, as well as an expanded requirement for dose escalations that are ongoing.
Initiated IND-enabling studies for Repare’s Polθ inhibitor (now designated RP-2119), and plan to initiate clinical trials in the summer of 2023.
Repare also expects to initiate IND-enabling studies in the first half of 2023 for an additional small molecule against an undisclosed target.
Second Quarter 2022 Financial Results:

Cash and cash equivalents and marketable securities: Cash and cash equivalents and marketable securities as of June 30, 2022 were $282.1 million, which excludes the $125 million now received from Roche and extends cash runway into 2026.
Revenue: Repare recognized revenue of $0.7 million and $1.1 million for the three and six-month periods ended June 30, 2022, respectively, in connection with the Bristol Myers Squibb agreement and research activities performed.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $31.5 million and $57.9 million for the three- and six-month periods ended June 30, 2022, respectively, as compared to $20.2 million and $36.7 million for the three- and six-month periods ended June 30, 2021. The increase in R&D expenses for the three- and six-month periods were primarily due to an increase in direct external costs, primarily for development activities as a result of increased efforts towards advancing the development of the RP-3500 and RP-6306 programs; personnel-related costs, primarily related to increased headcount in support of discovery and development activities; and other research and development costs.
General and administrative (G&A) expenses: G&A expenses were $7.9 million and $16.7 million for the three- and six-month periods ended June 30, 2022, respectively, as compared to $6.7 million and $12.0 million for the three- and six-month periods ended June 30, 2021. The increase in G&A expenses for the three- and six-month periods were primarily due to increases in personnel related costs including share-based compensation; professional costs; and other general and administrative costs.
Net loss: Net loss was $38.1 million, or $0.91 per share, and $72.9 million, or $1.74 per share, in the three- and six-month periods ended June 30, 2022, respectively, and $26.3 million, or $0.71 per share and $47.7 million, or $1.29 per share, in the three-month and six-month periods ended June 30, 2021, respectively.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On August 4, 2022 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported second quarter 2022 financial results and recent portfolio updates (Press release, SQZ Biotech, AUG 4, 2022, View Source [SID1234617609]).

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"We are excited by meaningful progress in our clinical trials and also the receipt of FDA Fast Track Designation for our APC clinical candidate across HPV16+ tumors," said Armon Sharei, Ph.D., CEO and Founder at SQZ Biotechnologies. "We also highlighted the progress in developing our Point-of-Care manufacturing system which supports our long-term vision to enable broad accessibility of cell therapies. Finally, I am delighted by the addition of our newest senior team member, Dr. Marshelle Smith Warren as our Chief Medical Officer, and the elevation of Micah Zajic to Chief Financial Officer."

Second Quarter 2022 and Recent Portfolio Updates

SQZ Antigen Presenting Cell ("APC") Platform in Oncology

Granted FDA Fast Track Designation for SQZ-PBMC-HPV, our APC clinical candidate, for HPV16+ advanced or metastatic tumors
Continued enrollment of high dose monotherapy and combination with checkpoint inhibitors in the Phase 1/2 (SQZ-PBMC-HPV) trial
SQZ Enhanced Antigen Presenting Cell ("eAPC") Platform in Oncology

Presented SQZ eAPC preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrating that delivery of multiple mRNAs encoding for disease-specific antigens and immune stimulators had a synergistic effect that substantially increased killer T cell activity in humanized mouse models
Initiated enrollment and opened additional sites for the monotherapy stage of the COMMANDER-001 Phase 1/2 (SQZ-eAPC-HPV) trial
SQZ Activating Antigen Carriers ("AAC") Platform in Oncology

Published trial in progress poster at the AACR (Free AACR Whitepaper) annual meeting highlighting the SQZ AAC platforms potential to drive robust CD8 T cell activation and tumor killing
Continued enrollment and opened additional sites for the monotherapy stage of the ENVOY-001 Phase 1/2 (SQZ-AAC-HPV-101) trial
SQZ Tolerizing Antigen Carriers ("TAC") Platform in Immune Tolerance

Published comprehensive preclinical research in Frontiers in Immunology
Progressed studies supporting anticipated TAC IND submission for celiac disease in the first half of 2023; company’s POC manufacturing system intended to produce clinical batches
SQZ Point-of-Care Manufacturing

Presented non-clinical POC manufacturing performance data at the American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting demonstrating reduced manufacturing time and comparable or improved product specifications relative to current cleanroom-based processes
Recent Corporate Highlights

Appointed two experienced executives to leadership roles: Marshelle Smith Warren, M.D. joined as Chief Medical Officer, and Micah Zajic was elevated to Chief Financial Officer
Second Quarter 2022 Financial Highlights

Revenue for the quarter ended June 30, 2022, was $3.2 million compared to $4.5 million for the same period in 2021
Research and development expenses for the quarter ended June 30, 2022, were $18.8 million compared to $17.7 million for the same period in 2021; the increase was primarily due to higher personnel-related costs including stock-based compensation expense, to support continued progress with the company’s pipeline
General and administrative expenses for the quarter ended June 30, 2022, were $7.0 million compared to $5.9 million for the same period in 2021; the increase was primarily due to higher personnel and other corporate-related costs, including stock-based compensation expense and other costs
Net loss for the quarter ended June 30, 2022, was $22.2 million, compared to $19.1 million for the same period in 2021
As of June 30, 2022, the Company had cash and cash equivalents of $105.6 million and anticipates this will be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023

On August 4, 2022 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported its second quarter 2022 financial results for the period ended June 30, 2022 (Press release, Merrimack, AUG 4, 2022, View Source [SID1234617608]).

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"We are pleased to report continued reductions in operating expenses as we remain focused on conserving cash to ensure that we have sufficient financial resources to capture future potential milestone payments from Ipsen Pharmacology and Elevation Oncology" said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We will continue to monitor developments in Ipsen’s Onivyde (irinotecan liposomal injection) program and Elevation’s seribantumab program."

Second Quarter 2022 Financial Results

Merrimack reported a net loss of $478 thousand for the second quarter ended June 30, 2022, or $0.04 per basic and diluted share on a fully diluted basis, compared to a net loss of $759 thousand, or $0.06 per basic and diluted share on a fully diluted basis, for the same period in 2021.

General and administrative expenses for the second quarter ended June 30, 2022, were $486 thousand, compared to $778 thousand for the same period in 2021.

As of June 30, 2022, Merrimack had cash and cash equivalents of $13.4 million, compared to $14.2 million as of December 31, 2021.

As of June 30, 2022, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

– On August 3, 2022, Ipsen announced results from its Phase III RESILIENT trial evaluating Onivyde in second-line monotherapy for small cell lung cancer. The announcement indicated that "the primary endpoint OS was not met in patients treated with Onivyde versus topotecan. However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed. The safety and tolerability of Onivyde was consistent with its already-known safety profile, and no new safety concerns emerged. The clinical study results will be communicated with the regulatory agency." Ipsen indicated in its update that it will analyze the data further before making decisions about next steps.

– On July 28, 2022, Ipsen provided a public update on its sales performance for the first half of 2022 and indicated that top line data from its continuing Phase 3 study of ONIVYDE in first line pancreatic ductal adenocarcinoma were anticipated to be available during the second half of 2022.

Elevation Oncology

– On May 26, 2022, Elevation Oncology released to the public initial proof-of-concept data from its phase 2 CRESTONE Study evaluating the HER3 monoclonal antibody seribantumab in patients with tumors harboring NRG1 fusions at ASCO (Free ASCO Whitepaper) 2022. The most recent corporate presentation from Elevation indicates that top line data from this trial are expected in 2024.

On August 4, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid"), a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that a recently published American Gastroenterological Association ("AGA") clinical practice update supports esophageal precancer ("Barrett’s Esophagus," "BE") screening to prevent highly lethal esophageal cancer ("EAC") utilizing its EsoGuard Esophageal DNA Test ("EsoGuard") on samples collected with its EsoCheck Cell Collection Device ("EsoCheck") (Press release, Lucid Diagnostics, AUG 4, 2022, View Source [SID1234617607]).

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The clinical practice update entitled "AGA Clinical Practice Update on New Technology and Innovation for Surveillance," the first such update since 2011, was recently published online in the journal, Clinical Gastroenterology and Hepatology. The expert review was commissioned by the AGA’s Clinical Practice Update Committee, its Center for GI Innovation and Technology, and Governing Board to "provide timely guidance on a topic of high clinical importance…" Senior author Srinadh Komanduri M.D., M.S., Professor of Medicine and Surgery, Associate Chief, Division of Gastroenterology and Hepatology and Director of Endoscopy at the Feinberg School of Medicine, Northwestern University, is a member of Lucid’s Medical Advisory Board.

The AGA update mirrors the recently updated American College of Gastroenterology ("ACG") clinical guideline on the same topic, by acknowledging the "significant need for noninvasive screening tools that are easy to administer, patient friendly, and cost-effective for the detection of BE," and endorsing, for the first time, such tools as an acceptable alternative to endoscopy to directly address this need.

Best Practice Advice 2: Non-Endoscopic Cell Collection Devices may be considered as an option to screen for BE.

The clinical practice update specifically mentions EsoCheck, along with Lucid’s EsophaCap device, as such "Non-endoscopic Cell Collection Devices" – the only such devices commercially available in the United States – indicating that they "have demonstrated excellent tolerability, safety, and sensitivity for the diagnosis of BE." The authors cite the seminal NIH-funded multicenter, case-control study published in 2018 in Science Translational Medicine, which demonstrated that EsoGuard is highly accurate at detecting esophageal precancer and cancer, including on samples collected with EsoCheck.

"We are gratified that the AGA has joined the ACG in updating their clinical practice guidelines to recognize the role that groundbreaking technologies, such as EsoGuard and EsoCheck, can play in driving widespread esophageal precancer screening to prevent esophageal cancer deaths," said Lishan Aklog M.D., Lucid’s Chairman and Chief Executive Officer. "We now have a consensus. The two leading gastroenterology professional associations support the use of our nonendoscopic tools as an acceptable alternative to endoscopy – which has unequivocally failed as a screening tool despite over a decade of clinical guidelines recommending screening of at-risk patients. This ongoing failure to screen makes the thousands of esophageal deaths in the U.S. each year a profound and preventable tragedy, which we are determined to eliminate."

The clinical practice update also significantly expands the target population for esophageal precancer screening, including for EsoGuard and EsoCheck, by recommending, for the first time, screening in at-risk patients without symptoms of reflux. The AGA does so by adding a history of chronic gastroesophageal disease ("GERD," commonly known as chronic heartburn) as merely an additional, seventh, risk factor to the six risk factors for BE and EAC that have traditionally identified at-risk symptomatic patients recommended for screening. As a result, chronic symptomatic GERD is no longer a mandatory prerequisite and asymptomatic patients with three other risk factors are now considered appropriate for screening.

Best Practice Advice 1: Screening with standard upper endoscopy may be considered in individuals with at least 3 established risk factors for Barrett’s esophagus (BE) and esophageal adenocarcinoma (EAC), including individuals who are male, non-Hispanic White, age >50 years, have a history of smoking, chronic GERD, obesity or a family history of BE or EAC.

It is estimated that approximately 40% of GERD patients have "silent GERD" without classic symptoms of heartburn, representing an estimated thirty million persons in addition to the estimated fifty million U.S. adults with weekly symptoms of GERD. The AGA experts based their expansion of the target screening population on a growing consensus, driven by data indicating that over 50% of U.S. patients diagnosed with esophageal cancer would not have qualified for screening per traditional clinical practice guidelines – nearly all because they lacked symptoms of GERD. A recently launched NIH-funded and Lucid-supported study, Detection of Barrett s Esophagus in Patients Without GERD Symptoms, seeks to directly demonstrate that EsoGuard performed by Lucid on samples collected with EsoCheck can detect esophageal precancer in such asymptomatic patients.

"We applaud this bold move by the AGA, which represents a profound paradigm shift in how we view screening for esophageal precancer," said Dr. Aklog. "Based on data its experts cite, removing symptomatic GERD as a mandatory prerequisite for screening has the potential to dramatically increase our ability to prevent esophageal cancer deaths through esophageal precancer screening. We believe that ongoing studies, including the NIH-funded ‘non-GERD’ study we are supporting, will provide additional clinical evidence to support the use of EsoGuard and EsoCheck in asymptomatic at-risk patients."

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard, performed on samples collected with EsoCheck, is the missing element – the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients. An updated American College of Gastroenterology clinical practice guideline and an American Gastroenterological Association clinical practice update both endorse nonendoscopic biomarker tests as an acceptable alternative to costly and invasive endoscopy for esophageal precancer screening. EsoGuard is the only such test currently available in the United States.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck, which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s CLIA-certified, CAP-accredited laboratory, LucidDx Labs, for EsoGuard testing.

On August 4, 2022 Thermo Fisher Scientific reported a next-generation sequencing (NGS)-based assay for research in myeloid measurable residual disease (MRD) (Press release, Thermo Fisher Scientific, AUG 4, 2022, View Source [SID1234617606]). As the first NGS-based tests to support both DNA and RNA input, the Ion Torrent Oncomine Myeloid MRD Assays (RUO)* provide a comprehensive and highly sensitive MRD assessment from blood and bone marrow samples.

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Acute myeloid leukemia (AML) is characterized by rapid disease progression and can be fatal if not treated promptly. Depending on their interventions, the number of AML patients who experience relapsed disease can be as high 78%1. Detecting remaining mutations after treatment can help identify the presence of residual disease and guide patient prognosis and further treatment decisions. This is driving a growing need for an MRD detection methods that can simultaneously track mutations across multiple genes with high sensitivity.

Current MRD detection methods do not evaluate individual mutations or can only track a very limited number at once. Thermo Fisher’s Myeloid MRD Assay has been designed to enable simultaneous testing and identification of more than 90% of common AML mutations and fusions, providing insights to guide the future of clinical applications, standards and drug development.

"MRD can help predict potential relapse in cancer patients but is not widely used for patients with AML due to lack of accurate, reproducible tests," said Luca Quagliata, global head of medical affairs at Thermo Fisher Scientific. "With the Myeloid MRD Assay, laboratories may perform comprehensive MRD analysis of mutations in myeloid samples to inform future clinical options. We are also working with the Foundation for the National Institutes of Health Biomarkers Consortium as they assess future requirements for validation and standardization of MRD as a biomarker, with the goal of improving care and advancing treatment development for patients with AML."

The Myeloid MRD Assay enables sensitive variant detection as low as 0.05% allele frequency for key DNA mutations in 33 genes and evaluation of more than 900 isoforms in 43 RNA fusion driver genes – including many targets for which there are no established assays to-date. The end-to-end workflow delivers results in as little as two days with an integrated informatics pipeline and reporting tool that can help to minimize user hands-on time and speed up time to results.

"There is a critical need for more effective disease monitoring and treatment for patients with AML who are at high risk of relapse. The MRD biomarker will be used to better understand disease progression and guide therapy decisions in the future, and as such MRD assessment is becoming an important part of cancer research today," said Bevan Tandon, MD, director of hematopathology and molecular pathology at Pathline, a leading provider of specialized pathology services. "By introducing an assay that can be evaluated as a more accurate and comprehensive way to measure residual disease, we can begin to make strides to realize the true clinical potential of MRD to improve patient outcomes."

To learn more about the Ion Torrent Oncomine Myeloid MRD Assay (RUO), please visit: www.oncomine.com/myeloid-mrd-ngs-assay

The Real-World Incidence of Relapse in Acute Myeloid Leukemia (AML): A Systematic Literature Review (SLR); Blood, Nov. 29, 2018.
*For research use only. Not for use in diagnostic procedures.