Medical Policy

Policy Num:      11.003.141
Policy Name:    Laboratory Testing Investigational Services
Policy ID:          [11.003.141] [Ac / B / M- / P-] [2.04.159]

Last Review:    December 05, 2024
Next Review:    November 20, 2024
 

Related Policies:

11.003.001 - Laboratory Tests Post Transplant and for Heart Failure
11.001.007 - Identification of Microorganisms Using Nucleic Acid Probes
11.001.015 - Cardiovascular Risk Panels
11.003.079- Multibiomarker Disease Activity Blood Test for Rheumatoid Arthritis
11.003.090- Gene Expression Profiling for Uveal Melanoma
11.003.096 - Miscellaneous Genetic and Molecular Diagnostic Tests
11.003.094- Serum Biomarker Panel Testing for Systemic Lupus Erythematosus and Other Connective Tissue Diseases
11.003.040 - Genetic Testing for Alzheimer Disease
11.001.032 - Evaluation of Biomarkers for Alzheimer Disease
11.003.087 - Molecular Testing in the Management of Pulmonary Nodules
11.003.097 - Gene Expression Profiling for Cutaneous Melanoma
11.003.133- Serologic Genetic and Molecular Screening for Colorectal Cancer
11.001.046 - Maternal Serum Biomarkers for Prediction of Adverse Obstetric Outcomes
11.003.034 - Genetic and Protein Biomarkers for the Diagnosis and Cancer Risk Assessment of Prostate Cancer
11.003.035 - Assays of Genetic Expression in Tumor Tissue as a Technique to Determine Prognosis in Patients with Breast Cancer
11.001.009 - Noninvasive Techniques for the Evaluation and Monitoring of Patients With Chronic Liver Disease
11.003.002 - Molecular Testing for the Management of Pancreatic Cysts, Barrett Esophagus, and Solid Pancreaticobiliary Lesions
11.003.047- Gene Expression-Based Assays for Cancers of Unknown Primary
11.003.015 - Gene Expression Profile Testing and Circulating Tumor DNA Testing for Predicting Recurrence in Colon Cancer
11.003.098- Use of Common Genetic Variants (Single Nucleotide Variants) to Predict Risk of Nonfamilial Breast Cancer
11.003.037- Novel Biomarkers in Risk Assessment and Management of Cardiovascular Disease
11.003.073 - Laboratory and Genetic Testing for Use of 5-Fluorouracil in Patients With Cancer
11.003.062 - General Approach to Genetic Testing
11.003.023 - General Approach to Evaluating the Utility of Genetic Panels
11.003.064- Genetic Cancer Susceptibility Panels Using Next Generation Sequencing
11.003.105 - Microarray-Based Gene Expression Profile Testing for Multiple Myeloma Risk Stratification

 Laboratory Testing Investigational Services

Summary

There are numerous commercially available genetic and molecular diagnostic, prognostic, and therapeutic tests for individuals with certain diseases or asymptomatic individuals with future risk. This review relates to genetic and molecular diagnostic tests not addressed in a separate review. If a separate evidence review exists, then conclusions reached there supersede conclusions here. The main criterion for inclusion in this review is the limited evidence on the clinical utility for the test. As these tests do not have clinical utility, the evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Summary of Evidence

For individuals with various indications for diagnostic, prognostic, therapeutic, or future risk assessment testing who receive the genetic and molecular tests addressed in this review, the evidence on clinical utility is insufficient or non-evaluable. For each test addressed, a brief description is provided for informational purposes. No formal evidence review was conducted. To sufficiently evaluate clinical utility, features of well-defined test, intended use, and clinical management pathway characteristics are summarized. If it is determined that enough evidence has accumulated to reevaluate its potential clinical utility, the test will be removed from this review and addressed separately. The lack of demonstrated clinical utility of these tests is based on the following factors: (1) there is no or extremely limited published data addressing the test; and/or (2) it is unclear where in the clinical pathway the test fits (replacement, triage, add-on); and/or (3) it is unclear how the test leads to changes in management that would improve health outcomes and/or avoiding existing burdensome and invasive testing; and/or (4) thresholds for decision making have not been established; (5) and/or the outcome from the test result does not result in a clinically meaningful improvement relative to the outcomes(s) obtained without the test.

Additional Information

The ArteraAI Prostate test has received a category 2A recommendation from the National Comprehensive Cancer Network. See the Supplemental Information section for additional details.

Objective

The objective of this review is to provide a list of diagnostic, prognostic, therapeutic, or future risk assessment genetic or molecular diagnostic tests with insufficient or non-evaluable clinical utility that are otherwise not addressed in a separate evidence review.

Policy Statements

All tests listed in this policy are considered investigational as there is insufficient evidence to determine that the technology results in an improvement in the net health outcome (see Policy Guidelines).

Policy Guidelines

Genetic testing is considered investigational when TSS/BCBSA criteria are not met, including when there is insufficient evidence to determine that the technology results in an improvement in the net health outcome. The following tests are considered investigational:

Please refer to the list of related evidence reviews for an assessment of other molecular and genetic tests not listed in this policy.

Genetics Nomenclature Update

The Human Genome Variation Society nomenclature is used to report information on variants found in DNA and serves as an international standard in DNA diagnostics. It is being implemented for genetic testing medical evidence review updates starting in 2017 (see Table PG1). The Society’s nomenclature is recommended by the Human Variome Project, the Human Genome Organization, and by the Human Genome Variation Society itself.

The American College of Medical Genetics and Genomics and the Association for Molecular Pathology standards and guidelines for interpretation of sequence variants represent expert opinion from both organizations, in addition to the College of American Pathologists. These recommendations primarily apply to genetic tests used in clinical laboratories, including genotyping, single genes, panels, exomes, and genomes. Table PG2 shows the recommended standard terminology to describe variants identified that cause Mendelian disorders.

Table PG1. Nomenclature to Report on Variants Found in DNA

Table PG2. American College of Medical Genetics and Genomics and the Association for Molecular Pathology Standards and Guidelines for Variant Classification

Genetic Counseling

Experts recommend formal genetic counseling for patients who are at-risk for inherited disorders and who wish to undergo genetic testing. Interpreting the results of genetic tests and understanding risk factors can be difficult for some patients; genetic counseling helps individuals understand the impact of genetic testing, including the possible effects the test results could have on the individual or their family members. It should be noted that genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing; further, genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

Some Plans may have contract or benefit exclusions for genetic testing. Some Plans may have state mandates for biomarker testing. 

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

This policy applies if there is not a separate evidence review that outlines specific criteria for testing. If a separate evidence review does exist, then the criteria for medical necessity therein supersede the guidelines herein.

This policy addresses laboratory services considered to be investigational. These tests are often available on a clinical basis before the required and necessary evidence base to support clinical validity and utility is established. Because these tests are often proprietary, there may be no independent test evaluation data available in the early stages to support the laboratory's claims regarding test performance and utility. While studies using these tests may generate information that may help elucidate the biologic mechanisms of disease and eventually help design treatments, the tests listed in this policy are currently in a developmental phase, with limited evidence of clinical utility for diagnosis, prognosis, or risk assessment.

Regulatory Status

Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments. Laboratories that offer laboratory-developed tests must be licensed by the Clinical Laboratory Improvement Amendments for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of this test.

Rationale

This review was created in June 2023 with a search of the PubMed database. The most recent literature update was performed through September 30, 2024.

Evidence reviews assess whether a medical test is clinically useful. A useful test provides information to make a clinical management decision that improves the net health outcome. That is, the balance of benefits and harms is better when the test is used to manage the condition than when another test or no test is used to manage the condition.

The first step in assessing a medical test is to formulate the clinical context and purpose of the test. The test must be technically reliable, clinically valid, and clinically useful for that purpose. Evidence reviews assess the evidence on whether a test is clinically valid and clinically useful. Technical reliability is outside the scope of these reviews, and credible information on technical reliability is available from other sources.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Laboratory Testing Investigational Services

Clinical Context and Test Purpose

The purpose of various commercially available genetic and molecular diagnostic, prognostic, and therapeutic tests for individuals with relevant indications is to inform a clinical management decision that improves the net health outcome.

No formal evidence review was conducted. To sufficiently evaluate clinical utility, the following PICO characteristics must be well-defined.

Populations

The relevant population of interest are individuals with various indications for diagnostic, prognostic, therapeutic, or future risk assessment testing.

To sufficiently evaluate clinical utility, the intended use population should be clearly defined, including disease state, stage or severity, prior treatment, and symptomatic status. For genetic diseases, details regarding inheritance and penetrance provide valuable context.

Interventions

This review addresses the following tests:

Table 1. Laboratory Testing Services^a

To sufficiently evaluate clinical utility, the characteristics of the test should be well-defined including thresholds, cutoffs, or classifications used for categorization. The intended use of the test should be clearly stated, including its position in the clinical pathway. Use of the test to replace an existing test or testing pathway (replacement), use before an existing test or testing pathway (triage), or use after an existing test or testing pathway (add-on) should be clearly specified.

Comparators

The clinical practice alternative to which the test is being compared should be clearly stated, including any applicable reference standards and any known disadvantages of the comparator that the test under evaluation aims to overcome.

Outcomes

The general outcomes of interest are symptoms, quality of life, medication use, change in disease status, and morbidity and mortality. Follow-up duration may be informed by the natural history of the disease.

Health outcomes measure length of life, quality of life, and the ability to function and occur as a consequence of the interventions taken as a result of the test. Clinical management decisions and physiologic measures that are not validated surrogates are not health outcomes. The beneficial outcomes resulting from a true test result and the harmful outcomes resulting from a false test result should be clearly stated. Clinical management recommendations for a test result that is discordant with another test applied in the clinical pathway should also be defined.

Clinically Useful

A test is clinically useful if the use of the results informs management decisions that improve the net health outcome of care. The net health outcome can be improved if patients receive correct therapy, or more effective therapy, or avoid unnecessary therapy, or avoid unnecessary testing.

The studies using the tests listed in this policy are currently in a developmental phase, with limited evidence of clinical utility for diagnosis, prognosis, or risk assessment. The lack of demonstrated clinical utility of these tests is based on the following factors: (1) there is no or extremely limited published data addressing the test; and/or (2) it is unclear where in the clinical pathway the test fits (replacement, triage, add-on); and/or (3) it is unclear how the test leads to changes in management that would improve health outcomes and/or avoiding existing burdensome and invasive testing; and/or (4) thresholds for decision making have not been established; (5) and/or the outcome from the test result does not change in a way we find value in, relative to the outcomes(s) obtained without the test.

With the clinical utility not established, evidence review of clinical validity was not performed.

Direct Evidence

Direct evidence of clinical utility is provided by studies that have compared health outcomes for patients managed with and without the test. Because these are intervention studies, the preferred evidence would be from randomized controlled trials.

Chain of Evidence

Indirect evidence on clinical utility rests on clinical validity. If the evidence is insufficient to demonstrate test performance, no inferences can be made about clinical utility.

For individuals with various indications for diagnostic, prognostic, therapeutic, or future risk assessment testing who receive the genetic and molecular tests addressed in this review, the evidence on clinical utility is insufficient or non-evaluable. For each test addressed, a brief description is provided for informational purposes. No formal evidence review was conducted. To sufficiently evaluate clinical utility, features of well-defined test, intended use, and clinical management pathway characteristics are summarized. If it is determined that enough evidence has accumulated to reevaluate its potential clinical utility, the test will be removed from this review and addressed separately. The lack of demonstrated clinical utility of these tests is based on the following factors: (1) there is no or extremely limited published data addressing the test; and/or (2) it is unclear where in the clinical pathway the test fits (replacement, triage, add-on); and/or (3) it is unclear how the test leads to changes in management that would improve health outcomes and/or avoiding existing burdensome and invasive testing; and/or (4) thresholds for decision making have not been established; (5) and/or the outcome from the test result does not result in a clinically meaningful improvement relative to the outcomes(s) obtained without the test.

SUPPLEMENTAL INFORMATION

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in 'Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Gastroenterology

In 2023, the American College of Gastroenterology published a clinical practice update for the diagnosis and management of celiac disease.^27, A recommendation for genetic testing using a multigene panel test (eg, Celiac PLUS) was not included.

In 2018, the American College of Gastroenterology practice guidelines on Crohn disease state that genetic and routine serologic testing is not indicated to establish the diagnosis of Crohn's disease.^28,

American Urological Association et al

In 2019, the American Urological Association (AUA) published joint guidelines with the Canadian Urological Association (CUA) and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) on the management of recurrent uncomplicated urinary tract infections in women.^29, Regarding the use of polymerase chain reaction (PCR) and next-generation sequencing (NGS) techniques for the identification of bacterial species, the guideline states that "more evidence is needed before these technologies become incorporated into the guideline, as there is concern that adoption of this technology in the evaluation of lower urinary tract symptoms may lead to over treatment with antibiotics."

In 2016, the AUA published joint guidelines with the Society of Urologic Oncology on the diagnosis and treatment of non-muscle invasive bladder cancer.^30, For use of urinary biomarkers after diagnosis, the guidelines state: "a clinician should not use urinary biomarkers in place of cystoscopic evaluation" (Strong Recommendation; Evidence Strength: Grade B); that "in a patient with a history of low-risk cancer and a normal cystoscopy, a clinician should not routinely use a urinary biomarker or cytology during surveillance (Expert Opinion); and that "in a patient with NMIBC, a clinician may use biomarkers to assess response to intravesical BCG (UroVysion FISH) and adjudicate equivocal cytology (UroVysion FISH and ImmunoCyt) (Expert Opinion)."

National Comprehensive Cancer Network

National Comprehensive Cancer Network clinical practice guidelines on bladder cancer (v.4.2024 ) state the following regarding urine molecular tests for urothelial tumor markers:^31, "Many of these tests have a better sensitivity for detecting bladder cancer than urinary cytology, but specificity is lower. Considering this, evaluation of urinary urothelial tumor markers may be considered during surveillance of high-risk [non-muscle invasive bladder cancer (NMIBC)]. However, it remains unclear whether these tests offer additional useful information for detection and management of non-muscle invasive bladder tumors. Therefore, the panel considers this to be a category 2B recommendation."

NCCN clinical practice guidelines on colon cancer (v.5.2024 ) state that "it has not been established if molecular markers (other than MSI-H/dMMR) are useful in treatment determination (predictive markers) and prognosis."^32,

NCCN clinical practice guidelines on prostate cancer (v.4.2024) state that "there are advanced risk stratification tools (ie, gene expression biomarkers, AI digital pathology) that have been variably demonstrated to independently improve risk stratification beyond NCCN or CAPRA risk stratification" and that "these tools are recommended to be used when they have the potential ability to change disease management. These tools should not be ordered reflexively. The most common treatment decisions in localized prostate cancer to use these tests include the use and/or intensity of active surveillance versus radical therapy, [radiotherapy](RT) versus RT + short-term (ST)-[androgen deprivation therapy](ADT), and RT + ST-ADT versus long-term (LT)-ADT. The most common treatment decisions in biochemically recurrent prostate cancer post-RP to use these tests include secondary RT versus secondary RT + ADT. These tools are not recommended for patients with very-low-risk prostate cancer. There are an extensive number of these tools created with substantial variability in quality of reporting and model design, endpoint selection, and quality and caliber of validation. It is recommended to use models that have high-quality and robust validation, ideally with high-quality, long-term clinical trial data, which usually comes from randomized trials and across multiple clinical trials."^33,For the ArteraAI Prostate test 2A recommendation, continuous scores may be used to provide more accurate risk stratification to inform shared decision-making; however, NCCN notes that "specific score cut points have not been published to date for specific treatment decisions." Predictive biomarker testing with ArteraAI in individuals with intermediate-risk prostate cancer can help to identify patients with a more favorable prognostic risk who "may consider the use of RT alone" without ST-ADT.

National Human Genome Research Institute et al

In 2021, the National Human Genome Research Institute's ClinGen Complex Disease Working Group updated the Genetic Risk Prediction (GRIPS) Reporting Statement in collaboration with the Polygenic Score (PGS) Catalog.^34, The 22-item reporting framework developed to define the minimal information needed to interpret and evaluate polygenic risk scores is summarized in Table 1.

Table 2. Polygenic Risk Score Reporting Statement

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 3.

Table 3. Summary of Key Trials

References

1. MicroGen Diagnostics. MicroGenDx: Information for Healthcare Professionals. 2023; https://microgendx.com/microgen-diagnostics-specialties/. Accessed September 30, 2024.
2. Quest Diagnostics. Apolipoprotein L1 (APOL1) Renal Risk Variant Genotyping. December 16, 2022; https://www.questdiagnostics.com/healthcare-professionals/clinical-education-center/faq/faq287#accordion-48070ca605-item-e92bca3e39. Accessed September 30, 2024.
3. Protean Biodiagnostics. Thyroid GuidePx. n.d.; https://www.proteanbiodx.com/thyroidguidepx. Accessed September 30, 2024.
4. Nonagen Bioscience. Introducing Oncuria: A Next-Generation Oncology Diagnostic. 2022; https://www.nonagen.com/products. Accessed September 30, 2024.
5. Murakami K, Kamat AM, Dai Y, et al. Application of a multiplex urinalysis test for the prediction of intravesical BCG treatment response: A pilot study. Cancer Biomark. 2022; 33(1): 151-157. PMID 34511488
6. DiaCarta. ColoScape Colorectal Cancer Detection Test. 2018; https://www.diacarta.com/services/coloscape. Accessed September 30, 2024.
7. ThermoFisher Scientific. Urinary Tract Infection (UTI) Testing Research Solutions. 2022; https://www.thermofisher.com/us/en/home/clinical/clinical-genomics/pathogen-detection-solutions/realtime-pcr-solution-urinary-tract-microbiota-detection.html. Accessed September 30, 2024.
8. Lab Genomics. Respiratory Panel (RP) Rapid Molecular Diagnostic Test. 2018; https://labgenomic.com/wp-content/uploads/2018/11/RPPanelPamphlet1.pdf. Accessed September 30, 2024.
9. Lab Genomics. Urinary Pathogen Test (UPX) Rapid Molecular Diagnostic Test. 2018; https://labgenomic.com/wp-content/uploads/2018/12/UTI-Brochure-FINAL.pdf. Accessed September 30, 2024.
10. ArteraAI. ArteraAI Prostate Test. n.d.; https://artera.ai/arteraai-prostate-cancer-test. Accessed September 30, 2024.
11. CIMA Sciences LLC. Liposcale Advanced Lipoprotein Test. 2024; https://cimasciences.com/liposcale/. Accessed on September 30, 2024.
12. Lab Genomics. Drug Metabolism. n.d.; https://labgenomic.com/drug-metabolism/. Accessed September 30, 2024.
13. Journey Biosciences. NaviDKD: A Powerful Predictive Screening. 2023; https://www.journeybio.life/solution#start-your-journey. Accessed September 30, 2024.
14. Sonic Reference Laboratory. PromarkerD Diabetic Kidney Disease Risk Assessment. 2023; https://www.sonicreferencelab.com/featured-testing/diabetic-kidney-disease-risk-assessment/. Accessed September 30, 2024.
15. Previse. Esopredict: Information for Healthcare Providers. 2023; https://previsedx.com/our-test/esopredict-for-providers/. Accessed September 30, 2024.
16. mProbe, Inc. Kawasaki Disease. 2023; https://www.mprobe.com/kawasakidx. Accessed September 30, 2024.
17. Breakthrough Genomics. Welcome to Breakthrough Genomics. 2023; https://btgenomics.com/. Accessed September 30, 2024.
18. Precision Pathology Services. Why Use CyPath Lung. 2022; https://cypath.precisionpath.us/cypath-physician/. Accessed September 30, 2024.
19. ClearNote Health. Avantect Pancreatic Cancer Test. 2023; https://www.avantect.com/avantect-test/. Accessed September 30, 2024.
20. SmartHealth Dx. SmartVascular Dx. 2023; https://www.smarthealthdx.com/smartvascular-dx/. Accessed September 30, 2024.
21. Prometheus Laboratories. Prometheus Celiac Plus. 2023; https://prometheuslabs.com/disease-tests/celiac-plus/. Accessed September 30, 2024.
22. Prometheus Laboratories. Prometheus Crohn's Prognostics. 2023; https://prometheuslabs.com/disease-tests/crohns-prognostic/. Accessed September 27, 2024.
23. Mosaic Diagnostics. DNA Methylation Pathway Profile. 2023; https://mosaicdx.com/test/dna-methylation-pathway-profile/. Accessed September 30, 2024.
24. Genova Diagnostics. GI effects. n.d.; https://www.gdx.net/products/gi-effects. Accessed September 30, 2024.
25. Prometheus Laboratories. Prometheus IBD sgi Diagnostic. 2023; https://prometheuslabs.com/disease-tests/ibd-sgi-diagnostic/. Accessed September 26, 2024.
26. Strand Diagnostics. Know Error: Be DNA Certain. 2020; https://knowerror.com/index.html. Accessed September 30, 2024.
27. Singh S, Ananthakrishnan AN, Nguyen NH, et al. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis. Gastroenterology. Mar 2023; 164(3): 344-372. PMID 36822736
28. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG Clinical Guideline: Management of Crohn's Disease in Adults. Am J Gastroenterol. Apr 2018; 113(4): 481-517. PMID 29610508
29. Anger J, Lee U, Ackerman AL, et al. Recurrent Uncomplicated Urinary Tract Infections in Women: AUA/CUA/SUFU Guideline. J Urol. Aug 2019; 202(2): 282-289. PMID 31042112
30. Chang SS, Boorjian SA, Chou R, et al. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. Oct 2016; 196(4): 1021-9. PMID 27317986
31. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Bladder Cancer [Version 4.2024]. May 9, 2024; https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed September 27, 2024.
32. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer [Version 5.2024]. August 22, 2024; https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed September 24, 2024.
33. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Prostate Cancer [Version 4.2024]. May 17, 2024; https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed September 30, 2024.
34. Wand H, Lambert SA, Tamburro C, et al. Improving reporting standards for polygenic scores in risk prediction studies. Nature. Mar 2021; 591(7849): 211-219. PMID 33692554

Codes

Policy History