pharmaobservatory 0.1.9 → 0.1.11

checksums.yaml

@@ -1,7 +1,7 @@
 ---
 SHA256:
-  metadata.gz: ec60072e6a24fd72f4c13cb34b79a5271e1a3ce862796159f62fb51f023bba93
-  data.tar.gz: 7979111fa2b941322c3819002ea629891a83409777c25913be0e5dec25efa5f8
+  metadata.gz: 1d2fedc545786417fa3b64f5bede25492735f69856a66dbe4cb39f1676ae3787
+  data.tar.gz: 633f8ddfa4a594d0a504d4bfd5a27aa6722c079aa2e56a47d03126ca46810cda
 SHA512:
-  metadata.gz: cc2a715fdcbea13eac04de390051020c7af6036ffee14680b49f3d8c515267bc8a88275327fc7ed8011c41c0d9804dee65daca60d351d00db4a975b2f0c1038b
-  data.tar.gz: 954fce301c4e40b7b5ccdf4c792ada9e349e1acf8fe9f02776c86fedb3d524893592d711cbd0109f157565acab56cec008d8e6f191b267e7da523975a05b7f95
+  metadata.gz: dead207574db5d949dc1a08e2cc7262502cab0f09ea3e6e877ca626c4886adcb9317803c86e526c0afb07951c8322da873f7ae03cb1aca63760597598676a661
+  data.tar.gz: 4f1324c45f48da365153f1c28990dd7b7a80aff4d342bd2ccbfe2ea43c13c4dde0b922cb3c9907770b59e6aa2b95af3e29b5c2a93ec5941a180042e6dee835f9

data/README.md

@@ -39,7 +39,7 @@ Read-only REST API over the Pharma Observatory biomedical data platform. Referen
 This SDK is automatically generated by the [OpenAPI Generator](https://openapi-generator.tech) project:
 
 - API version: 1.0.0
-- Package version: 0.1.9
+- Package version: 0.1.11
 - Generator version: 7.13.0
 - Build package: org.openapitools.codegen.languages.RubyClientCodegen
 
@@ -56,16 +56,16 @@ gem build pharmaobservatory.gemspec
 Then either install the gem locally:
 
 ```shell
-gem install ./pharmaobservatory-0.1.9.gem
+gem install ./pharmaobservatory-0.1.11.gem
 ```
 
-(for development, run `gem install --dev ./pharmaobservatory-0.1.9.gem` to install the development dependencies)
+(for development, run `gem install --dev ./pharmaobservatory-0.1.11.gem` to install the development dependencies)
 
 or publish the gem to a gem hosting service, e.g. [RubyGems](https://rubygems.org/).
 
 Finally add this to the Gemfile:
 
-    gem 'pharmaobservatory', '~> 0.1.9'
+    gem 'pharmaobservatory', '~> 0.1.11'
 
 ### Install from Git
 

data/docs/BiomarkerAssayEvidenceRow.md

@@ -20,7 +20,7 @@
 | **comparator_method** | **String** | The reference method the performance was measured against, when reported. | [optional] |
 | **reported_performance** | **String** | The performance as the paper states it (sensitivity, specificity, area under the curve), as text and not computed. | [optional] |
 | **validation_type_mentioned** | **String** | What the paper claims about the validation type: a fact about the text, not a tier. | [optional] |
-| **assay_provider_company** | **Array<String>** | Organization names as extracted that run or provide the assay. Not resolved to a company. | [optional] |
+| **assay_provider_company** | **Array<String>** | The first extraction's flat list of organization names, as extracted, with no role. Not resolved to a company, and it names any company a paper mentions. Who makes or runs an assay for a biomarker, with the role, is the biomarker_assay_providers dataset. | [optional] |
 | **funding_organizations** | **Array<String>** | Organization names as extracted that funded the study. Never merged with the assay provider. | [optional] |
 | **evidence_type** | **String** | Always literature_assay_validation, which tells these rows from the other evidence types. | [optional] |
 | **evidence_quote** | **Array<String>** | The sentences of the paper the facts were read from. Null when the extraction gave none. | [optional] |

data/docs/BiomarkerAssayProvidersRow.md

@@ -9,9 +9,12 @@
 | **biomarker_id** | **String** | The biomarker's own key; null for a pair whose gene did not resolve. | [optional] |
 | **biomarker_display_name** | **String** | The biomarker's name, as resolved or else as extracted. | [optional] |
 | **gene_resolution_status** | **String** | resolved: the gene resolved. unresolved: a gene symbol was extracted and matched nothing. not_applicable: no gene symbol was extracted. | [optional] |
-| **company_name_key** | **String** | The normalised company name the provider rows are grouped on. | [optional] |
+| **provider_key** | **String** | The provider the rows are grouped on. org: followed by the organization key when the company resolves to an organization, otherwise name: followed by the normalised company name. | [optional] |
+| **provider_role** | **String** | What the papers name the provider as. assay_or_test_maker makes the assay or test; testing_service runs it as a service; both when the pair has papers of each kind. | [optional] |
 | **provider_name** | **String** | The provider company name as it appears in the papers. | [optional] |
-| **provider_org_id** | **String** | The provider's legal entity key, where the marketplace match resolves one. | [optional] |
+| **provider_org_id** | **String** | The organization the provider's company name resolved to (the member organization, not its parent); null when the provider is ambiguous or unresolved. Reached by the rung named in provider_org_match_tier. | [optional] |
+| **provider_org_match_tier** | **String** | How the provider was resolved to an organization, first rung that yields one organization wins. alias_exact: a reviewed brand alias, then exactly one organization carries the name. name_exact: exactly one organization carries the name. parent_unanimous: several organizations carry the name and all roll up to one parent, which is the organization. sponsor_key: the name is a trial-sponsor key. rx_provider_link: through its marketplace supplier. ambiguous: organizations under more than one parent carry the name, so none is chosen. unresolved: no organization, the provider stays a name. | [optional] |
+| **provider_parent_org_id** | **String** | The resolved parent of provider_org_id in the organization hierarchy (the organization itself when it has none); null when the provider has no organization. The hierarchy is not guaranteed correct for every company, so read it with provider_org_match_tier. | [optional] |
 | **provider_company_id** | **String** | The provider's company key. | [optional] |
 | **provider_company_name** | **String** | The provider's company name. | [optional] |
 | **provider_group_id** | **String** | The provider's current ultimate parent group key. | [optional] |
@@ -29,9 +32,26 @@
 | **most_recent_pmid** | **String** | The PubMed id of the most recent dated paper. | [optional] |
 | **most_recent_title** | **String** | The title of that paper. | [optional] |
 | **meets_curated_threshold** | **Boolean** | True when the provider matches a marketplace supplier or at least two papers name the pair. | [optional] |
-| **assay_provider_class** | **String** | The company-level class. diagnostic_provider makes or supplies the diagnostic assay; reagent_supplier is the vendor whose kit appears in a methods section; context_dependent, pharma_or_other and not_a_company are the other decisions; unclassified means no decision yet. | [optional] |
-| **assay_provider_class_source** | **String** | Where the class decision came from; null when unclassified. | [optional] |
-| **assay_provider_class_decided_at** | **Time** | When the class was decided, in UTC; null when unclassified. | [optional] |
+| **regulatory_evidence_kind** | **String** | The strongest US FDA or CMS record found for the pair. companion_diagnostic: the provider holds an FDA companion diagnostic for the biomarker. fda_cleared_specific_assay: a cleared or approved device of the provider that the paper names and that measures the biomarker. fda_cleared_for_biomarker: the provider holds a cleared or approved IVD under a product code for the biomarker. clia_testing_service: the provider is named as a testing service and its own organization holds a CLIA certificate. fda_ivd_company_only: the provider holds some cleared or approved IVD, none matched to the biomarker. none: no FDA record found. | [optional] |
+| **has_fda_record_for_biomarker** | **Boolean** | True when regulatory_evidence_kind is one of the first four kinds, a record that concerns the biomarker rather than only the company. | [optional] |
+| **regulatory_evidence_reasons** | **Array<String>** | Every level that held for the pair, strongest first; empty when none did. | [optional] |
+| **n_fda_ivd_510k** | **Integer** | The 510(k) clearances in the in-vitro diagnostic review panels held by the provider's organization (or, when it holds none, by organizations under its parent; fda_company_match_rung says which). Null for a provider that did not resolve to an organization. | [optional] |
+| **n_fda_ivd_pma** | **Integer** | The PMA approvals (distinct approval numbers) in the in-vitro diagnostic review panels held by the provider's organization or its parent family, on the same rung as n_fda_ivd_510k. Null for a provider that did not resolve to an organization. | [optional] |
+| **fda_company_match_rung** | **String** | org: the counted records are held by the provider's own organization. parent: by organizations under the same resolved parent. Null when the provider holds none. | [optional] |
+| **n_fda_analyte_510k** | **Integer** | The provider's 510(k) clearances under a product code mapped to this biomarker. Null when the provider or the biomarker did not resolve. | [optional] |
+| **n_fda_analyte_pma** | **Integer** | The provider's PMA approvals under a product code mapped to this biomarker. Null when the provider or the biomarker did not resolve. | [optional] |
+| **fda_analyte_product_codes** | **Array<String>** | The FDA product codes behind n_fda_analyte_510k and n_fda_analyte_pma. | [optional] |
+| **fda_analyte_fda_url** | **String** | The FDA database page of the provider's most recent record under a product code for this biomarker. | [optional] |
+| **specific_assay_matched** | **Boolean** | True when a paper names a cleared or approved device of this provider that measures this biomarker. The device name matches the paper's assay name, or the company's own quote, and the device's analyte agrees with the biomarker. | [optional] |
+| **specific_assay_device_name** | **String** | The 510(k) device name or PMA trade name of the matched device; the best match when several matched. Null when no device matched. | [optional] |
+| **specific_assay_k_number** | **String** | The 510(k) number of the matched device; null when the match is a PMA or there is none. | [optional] |
+| **specific_assay_pma_number** | **String** | The PMA number of the matched device; null when the match is a 510(k) or there is none. | [optional] |
+| **specific_assay_fda_url** | **String** | The FDA database page of the matched device. | [optional] |
+| **specific_assay_similarity** | **Float** | The trigram text similarity (0 to 1) of the larger of the two text clauses that matched the device, the paper's assay name or the company's quote against the device name. | [optional] |
+| **n_cdx_entries** | **Integer** | The FDA companion diagnostic list entries for this biomarker from this provider's organization (or its parent family). Null when the provider or the biomarker did not resolve. | [optional] |
+| **cdx_diagnostic_names** | **Array<String>** | The names of those companion diagnostics. | [optional] |
+| **n_clia_certificates** | **Integer** | The CLIA (US clinical laboratory) certificates held by the provider's organization, or by organizations under its parent when it holds none (clia_match_rung says which). A certificate licenses a lab; it is not evidence that any named assay is run. Null for a provider that did not resolve to an organization. | [optional] |
+| **clia_match_rung** | **String** | org: the counted certificates are held by the provider's own organization. parent: by organizations under the same resolved parent. Null when the provider holds none. | [optional] |
 
 ## Example
 
@@ -44,9 +64,12 @@ instance = PharmaObservatory::BiomarkerAssayProvidersRow.new(
   biomarker_id: null,
   biomarker_display_name: null,
   gene_resolution_status: null,
-  company_name_key: null,
+  provider_key: null,
+  provider_role: null,
   provider_name: null,
   provider_org_id: null,
+  provider_org_match_tier: null,
+  provider_parent_org_id: null,
   provider_company_id: null,
   provider_company_name: null,
   provider_group_id: null,
@@ -64,9 +87,26 @@ instance = PharmaObservatory::BiomarkerAssayProvidersRow.new(
   most_recent_pmid: null,
   most_recent_title: null,
   meets_curated_threshold: null,
-  assay_provider_class: null,
-  assay_provider_class_source: null,
-  assay_provider_class_decided_at: null
+  regulatory_evidence_kind: null,
+  has_fda_record_for_biomarker: null,
+  regulatory_evidence_reasons: null,
+  n_fda_ivd_510k: null,
+  n_fda_ivd_pma: null,
+  fda_company_match_rung: null,
+  n_fda_analyte_510k: null,
+  n_fda_analyte_pma: null,
+  fda_analyte_product_codes: null,
+  fda_analyte_fda_url: null,
+  specific_assay_matched: null,
+  specific_assay_device_name: null,
+  specific_assay_k_number: null,
+  specific_assay_pma_number: null,
+  specific_assay_fda_url: null,
+  specific_assay_similarity: null,
+  n_cdx_entries: null,
+  cdx_diagnostic_names: null,
+  n_clia_certificates: null,
+  clia_match_rung: null
 )
 ```
 

data/docs/BiomarkersRow.md

@@ -30,7 +30,7 @@
 | **has_analytical_validation_evidence** | **Boolean** | Whether analytical validation evidence exists. | [optional] |
 | **n_assay_provider_papers** | **Integer** | Papers naming an assay provider for the biomarker. | [optional] |
 | **n_assay_provider_suppliers** | **Integer** | Assay-provider suppliers named. | [optional] |
-| **n_diagnostic_provider_suppliers** | **Integer** | Of those, diagnostic providers. | [optional] |
+| **n_fda_evidence_providers** | **Integer** | Of those, providers with an FDA record found for the biomarker (a companion diagnostic, a cleared or approved device the paper names, a cleared or approved IVD under the analyte's product code, or a CLIA-certified lab that ran the test). US only; no record found is not a statement about validation. Null when no assay provider is named for the biomarker. | [optional] |
 
 ## Example
 
@@ -64,7 +64,7 @@ instance = PharmaObservatory::BiomarkersRow.new(
   has_analytical_validation_evidence: null,
   n_assay_provider_papers: null,
   n_assay_provider_suppliers: null,
-  n_diagnostic_provider_suppliers: null
+  n_fda_evidence_providers: null
 )
 ```
 

data/lib/pharmaobservatory/models/biomarker_assay_evidence_row.rb

@@ -64,7 +64,7 @@ module PharmaObservatory
     # What the paper claims about the validation type: a fact about the text, not a tier.
     attr_accessor :validation_type_mentioned
 
-    # Organization names as extracted that run or provide the assay. Not resolved to a company.
+    # The first extraction's flat list of organization names, as extracted, with no role. Not resolved to a company, and it names any company a paper mentions. Who makes or runs an assay for a biomarker, with the role, is the biomarker_assay_providers dataset.
     attr_accessor :assay_provider_company
 
     # Organization names as extracted that funded the study. Never merged with the assay provider.

data/lib/pharmaobservatory/models/biomarker_assay_providers_row.rb

@@ -14,7 +14,7 @@ require 'date'
 require 'time'
 
 module PharmaObservatory
-  # One row of the biomarker_assay_providers dataset: one row per biomarker key and assay-provider company name key. A grouped request returns the group columns and the measures instead, as additional properties.
+  # One row of the biomarker_assay_providers dataset: one row per biomarker key and provider key. A grouped request returns the group columns and the measures instead, as additional properties.
   class BiomarkerAssayProvidersRow
     # The route key of the gene the biomarker resolved to, the entry key for the biomarkers object type. Null when the extraction did not resolve a gene.
     attr_accessor :route_key
@@ -31,15 +31,24 @@ module PharmaObservatory
     # resolved: the gene resolved. unresolved: a gene symbol was extracted and matched nothing. not_applicable: no gene symbol was extracted.
     attr_accessor :gene_resolution_status
 
-    # The normalised company name the provider rows are grouped on.
-    attr_accessor :company_name_key
+    # The provider the rows are grouped on. org: followed by the organization key when the company resolves to an organization, otherwise name: followed by the normalised company name.
+    attr_accessor :provider_key
+
+    # What the papers name the provider as. assay_or_test_maker makes the assay or test; testing_service runs it as a service; both when the pair has papers of each kind.
+    attr_accessor :provider_role
 
     # The provider company name as it appears in the papers.
     attr_accessor :provider_name
 
-    # The provider's legal entity key, where the marketplace match resolves one.
+    # The organization the provider's company name resolved to (the member organization, not its parent); null when the provider is ambiguous or unresolved. Reached by the rung named in provider_org_match_tier.
     attr_accessor :provider_org_id
 
+    # How the provider was resolved to an organization, first rung that yields one organization wins. alias_exact: a reviewed brand alias, then exactly one organization carries the name. name_exact: exactly one organization carries the name. parent_unanimous: several organizations carry the name and all roll up to one parent, which is the organization. sponsor_key: the name is a trial-sponsor key. rx_provider_link: through its marketplace supplier. ambiguous: organizations under more than one parent carry the name, so none is chosen. unresolved: no organization, the provider stays a name.
+    attr_accessor :provider_org_match_tier
+
+    # The resolved parent of provider_org_id in the organization hierarchy (the organization itself when it has none); null when the provider has no organization. The hierarchy is not guaranteed correct for every company, so read it with provider_org_match_tier.
+    attr_accessor :provider_parent_org_id
+
     # The provider's company key.
     attr_accessor :provider_company_id
 
@@ -91,14 +100,65 @@ module PharmaObservatory
     # True when the provider matches a marketplace supplier or at least two papers name the pair.
     attr_accessor :meets_curated_threshold
 
-    # The company-level class. diagnostic_provider makes or supplies the diagnostic assay; reagent_supplier is the vendor whose kit appears in a methods section; context_dependent, pharma_or_other and not_a_company are the other decisions; unclassified means no decision yet.
-    attr_accessor :assay_provider_class
+    # The strongest US FDA or CMS record found for the pair. companion_diagnostic: the provider holds an FDA companion diagnostic for the biomarker. fda_cleared_specific_assay: a cleared or approved device of the provider that the paper names and that measures the biomarker. fda_cleared_for_biomarker: the provider holds a cleared or approved IVD under a product code for the biomarker. clia_testing_service: the provider is named as a testing service and its own organization holds a CLIA certificate. fda_ivd_company_only: the provider holds some cleared or approved IVD, none matched to the biomarker. none: no FDA record found.
+    attr_accessor :regulatory_evidence_kind
+
+    # True when regulatory_evidence_kind is one of the first four kinds, a record that concerns the biomarker rather than only the company.
+    attr_accessor :has_fda_record_for_biomarker
+
+    # Every level that held for the pair, strongest first; empty when none did.
+    attr_accessor :regulatory_evidence_reasons
+
+    # The 510(k) clearances in the in-vitro diagnostic review panels held by the provider's organization (or, when it holds none, by organizations under its parent; fda_company_match_rung says which). Null for a provider that did not resolve to an organization.
+    attr_accessor :n_fda_ivd_510k
+
+    # The PMA approvals (distinct approval numbers) in the in-vitro diagnostic review panels held by the provider's organization or its parent family, on the same rung as n_fda_ivd_510k. Null for a provider that did not resolve to an organization.
+    attr_accessor :n_fda_ivd_pma
+
+    # org: the counted records are held by the provider's own organization. parent: by organizations under the same resolved parent. Null when the provider holds none.
+    attr_accessor :fda_company_match_rung
+
+    # The provider's 510(k) clearances under a product code mapped to this biomarker. Null when the provider or the biomarker did not resolve.
+    attr_accessor :n_fda_analyte_510k
+
+    # The provider's PMA approvals under a product code mapped to this biomarker. Null when the provider or the biomarker did not resolve.
+    attr_accessor :n_fda_analyte_pma
+
+    # The FDA product codes behind n_fda_analyte_510k and n_fda_analyte_pma.
+    attr_accessor :fda_analyte_product_codes
+
+    # The FDA database page of the provider's most recent record under a product code for this biomarker.
+    attr_accessor :fda_analyte_fda_url
+
+    # True when a paper names a cleared or approved device of this provider that measures this biomarker. The device name matches the paper's assay name, or the company's own quote, and the device's analyte agrees with the biomarker.
+    attr_accessor :specific_assay_matched
+
+    # The 510(k) device name or PMA trade name of the matched device; the best match when several matched. Null when no device matched.
+    attr_accessor :specific_assay_device_name
+
+    # The 510(k) number of the matched device; null when the match is a PMA or there is none.
+    attr_accessor :specific_assay_k_number
+
+    # The PMA number of the matched device; null when the match is a 510(k) or there is none.
+    attr_accessor :specific_assay_pma_number
 
-    # Where the class decision came from; null when unclassified.
-    attr_accessor :assay_provider_class_source
+    # The FDA database page of the matched device.
+    attr_accessor :specific_assay_fda_url
 
-    # When the class was decided, in UTC; null when unclassified.
-    attr_accessor :assay_provider_class_decided_at
+    # The trigram text similarity (0 to 1) of the larger of the two text clauses that matched the device, the paper's assay name or the company's quote against the device name.
+    attr_accessor :specific_assay_similarity
+
+    # The FDA companion diagnostic list entries for this biomarker from this provider's organization (or its parent family). Null when the provider or the biomarker did not resolve.
+    attr_accessor :n_cdx_entries
+
+    # The names of those companion diagnostics.
+    attr_accessor :cdx_diagnostic_names
+
+    # The CLIA (US clinical laboratory) certificates held by the provider's organization, or by organizations under its parent when it holds none (clia_match_rung says which). A certificate licenses a lab; it is not evidence that any named assay is run. Null for a provider that did not resolve to an organization.
+    attr_accessor :n_clia_certificates
+
+    # org: the counted certificates are held by the provider's own organization. parent: by organizations under the same resolved parent. Null when the provider holds none.
+    attr_accessor :clia_match_rung
 
     # Attribute mapping from ruby-style variable name to JSON key.
     def self.attribute_map
@@ -108,9 +168,12 @@ module PharmaObservatory
         :'biomarker_id' => :'biomarker_id',
         :'biomarker_display_name' => :'biomarker_display_name',
         :'gene_resolution_status' => :'gene_resolution_status',
-        :'company_name_key' => :'company_name_key',
+        :'provider_key' => :'provider_key',
+        :'provider_role' => :'provider_role',
         :'provider_name' => :'provider_name',
         :'provider_org_id' => :'provider_org_id',
+        :'provider_org_match_tier' => :'provider_org_match_tier',
+        :'provider_parent_org_id' => :'provider_parent_org_id',
         :'provider_company_id' => :'provider_company_id',
         :'provider_company_name' => :'provider_company_name',
         :'provider_group_id' => :'provider_group_id',
@@ -128,9 +191,26 @@ module PharmaObservatory
         :'most_recent_pmid' => :'most_recent_pmid',
         :'most_recent_title' => :'most_recent_title',
         :'meets_curated_threshold' => :'meets_curated_threshold',
-        :'assay_provider_class' => :'assay_provider_class',
-        :'assay_provider_class_source' => :'assay_provider_class_source',
-        :'assay_provider_class_decided_at' => :'assay_provider_class_decided_at'
+        :'regulatory_evidence_kind' => :'regulatory_evidence_kind',
+        :'has_fda_record_for_biomarker' => :'has_fda_record_for_biomarker',
+        :'regulatory_evidence_reasons' => :'regulatory_evidence_reasons',
+        :'n_fda_ivd_510k' => :'n_fda_ivd_510k',
+        :'n_fda_ivd_pma' => :'n_fda_ivd_pma',
+        :'fda_company_match_rung' => :'fda_company_match_rung',
+        :'n_fda_analyte_510k' => :'n_fda_analyte_510k',
+        :'n_fda_analyte_pma' => :'n_fda_analyte_pma',
+        :'fda_analyte_product_codes' => :'fda_analyte_product_codes',
+        :'fda_analyte_fda_url' => :'fda_analyte_fda_url',
+        :'specific_assay_matched' => :'specific_assay_matched',
+        :'specific_assay_device_name' => :'specific_assay_device_name',
+        :'specific_assay_k_number' => :'specific_assay_k_number',
+        :'specific_assay_pma_number' => :'specific_assay_pma_number',
+        :'specific_assay_fda_url' => :'specific_assay_fda_url',
+        :'specific_assay_similarity' => :'specific_assay_similarity',
+        :'n_cdx_entries' => :'n_cdx_entries',
+        :'cdx_diagnostic_names' => :'cdx_diagnostic_names',
+        :'n_clia_certificates' => :'n_clia_certificates',
+        :'clia_match_rung' => :'clia_match_rung'
       }
     end
 
@@ -152,9 +232,12 @@ module PharmaObservatory
         :'biomarker_id' => :'String',
         :'biomarker_display_name' => :'String',
         :'gene_resolution_status' => :'String',
-        :'company_name_key' => :'String',
+        :'provider_key' => :'String',
+        :'provider_role' => :'String',
         :'provider_name' => :'String',
         :'provider_org_id' => :'String',
+        :'provider_org_match_tier' => :'String',
+        :'provider_parent_org_id' => :'String',
         :'provider_company_id' => :'String',
         :'provider_company_name' => :'String',
         :'provider_group_id' => :'String',
@@ -172,9 +255,26 @@ module PharmaObservatory
         :'most_recent_pmid' => :'String',
         :'most_recent_title' => :'String',
         :'meets_curated_threshold' => :'Boolean',
-        :'assay_provider_class' => :'String',
-        :'assay_provider_class_source' => :'String',
-        :'assay_provider_class_decided_at' => :'Time'
+        :'regulatory_evidence_kind' => :'String',
+        :'has_fda_record_for_biomarker' => :'Boolean',
+        :'regulatory_evidence_reasons' => :'Array<String>',
+        :'n_fda_ivd_510k' => :'Integer',
+        :'n_fda_ivd_pma' => :'Integer',
+        :'fda_company_match_rung' => :'String',
+        :'n_fda_analyte_510k' => :'Integer',
+        :'n_fda_analyte_pma' => :'Integer',
+        :'fda_analyte_product_codes' => :'Array<String>',
+        :'fda_analyte_fda_url' => :'String',
+        :'specific_assay_matched' => :'Boolean',
+        :'specific_assay_device_name' => :'String',
+        :'specific_assay_k_number' => :'String',
+        :'specific_assay_pma_number' => :'String',
+        :'specific_assay_fda_url' => :'String',
+        :'specific_assay_similarity' => :'Float',
+        :'n_cdx_entries' => :'Integer',
+        :'cdx_diagnostic_names' => :'Array<String>',
+        :'n_clia_certificates' => :'Integer',
+        :'clia_match_rung' => :'String'
       }
     end
 
@@ -186,9 +286,12 @@ module PharmaObservatory
         :'biomarker_id',
         :'biomarker_display_name',
         :'gene_resolution_status',
-        :'company_name_key',
+        :'provider_key',
+        :'provider_role',
         :'provider_name',
         :'provider_org_id',
+        :'provider_org_match_tier',
+        :'provider_parent_org_id',
         :'provider_company_id',
         :'provider_company_name',
         :'provider_group_id',
@@ -206,9 +309,26 @@ module PharmaObservatory
         :'most_recent_pmid',
         :'most_recent_title',
         :'meets_curated_threshold',
-        :'assay_provider_class',
-        :'assay_provider_class_source',
-        :'assay_provider_class_decided_at'
+        :'regulatory_evidence_kind',
+        :'has_fda_record_for_biomarker',
+        :'regulatory_evidence_reasons',
+        :'n_fda_ivd_510k',
+        :'n_fda_ivd_pma',
+        :'fda_company_match_rung',
+        :'n_fda_analyte_510k',
+        :'n_fda_analyte_pma',
+        :'fda_analyte_product_codes',
+        :'fda_analyte_fda_url',
+        :'specific_assay_matched',
+        :'specific_assay_device_name',
+        :'specific_assay_k_number',
+        :'specific_assay_pma_number',
+        :'specific_assay_fda_url',
+        :'specific_assay_similarity',
+        :'n_cdx_entries',
+        :'cdx_diagnostic_names',
+        :'n_clia_certificates',
+        :'clia_match_rung'
       ])
     end
 
@@ -248,8 +368,12 @@ module PharmaObservatory
         self.gene_resolution_status = attributes[:'gene_resolution_status']
       end
 
-      if attributes.key?(:'company_name_key')
-        self.company_name_key = attributes[:'company_name_key']
+      if attributes.key?(:'provider_key')
+        self.provider_key = attributes[:'provider_key']
+      end
+
+      if attributes.key?(:'provider_role')
+        self.provider_role = attributes[:'provider_role']
       end
 
       if attributes.key?(:'provider_name')
@@ -260,6 +384,14 @@ module PharmaObservatory
         self.provider_org_id = attributes[:'provider_org_id']
       end
 
+      if attributes.key?(:'provider_org_match_tier')
+        self.provider_org_match_tier = attributes[:'provider_org_match_tier']
+      end
+
+      if attributes.key?(:'provider_parent_org_id')
+        self.provider_parent_org_id = attributes[:'provider_parent_org_id']
+      end
+
       if attributes.key?(:'provider_company_id')
         self.provider_company_id = attributes[:'provider_company_id']
       end
@@ -328,16 +460,90 @@ module PharmaObservatory
         self.meets_curated_threshold = attributes[:'meets_curated_threshold']
       end
 
-      if attributes.key?(:'assay_provider_class')
-        self.assay_provider_class = attributes[:'assay_provider_class']
+      if attributes.key?(:'regulatory_evidence_kind')
+        self.regulatory_evidence_kind = attributes[:'regulatory_evidence_kind']
+      end
+
+      if attributes.key?(:'has_fda_record_for_biomarker')
+        self.has_fda_record_for_biomarker = attributes[:'has_fda_record_for_biomarker']
+      end
+
+      if attributes.key?(:'regulatory_evidence_reasons')
+        if (value = attributes[:'regulatory_evidence_reasons']).is_a?(Array)
+          self.regulatory_evidence_reasons = value
+        end
+      end
+
+      if attributes.key?(:'n_fda_ivd_510k')
+        self.n_fda_ivd_510k = attributes[:'n_fda_ivd_510k']
+      end
+
+      if attributes.key?(:'n_fda_ivd_pma')
+        self.n_fda_ivd_pma = attributes[:'n_fda_ivd_pma']
+      end
+
+      if attributes.key?(:'fda_company_match_rung')
+        self.fda_company_match_rung = attributes[:'fda_company_match_rung']
+      end
+
+      if attributes.key?(:'n_fda_analyte_510k')
+        self.n_fda_analyte_510k = attributes[:'n_fda_analyte_510k']
+      end
+
+      if attributes.key?(:'n_fda_analyte_pma')
+        self.n_fda_analyte_pma = attributes[:'n_fda_analyte_pma']
+      end
+
+      if attributes.key?(:'fda_analyte_product_codes')
+        if (value = attributes[:'fda_analyte_product_codes']).is_a?(Array)
+          self.fda_analyte_product_codes = value
+        end
+      end
+
+      if attributes.key?(:'fda_analyte_fda_url')
+        self.fda_analyte_fda_url = attributes[:'fda_analyte_fda_url']
+      end
+
+      if attributes.key?(:'specific_assay_matched')
+        self.specific_assay_matched = attributes[:'specific_assay_matched']
+      end
+
+      if attributes.key?(:'specific_assay_device_name')
+        self.specific_assay_device_name = attributes[:'specific_assay_device_name']
+      end
+
+      if attributes.key?(:'specific_assay_k_number')
+        self.specific_assay_k_number = attributes[:'specific_assay_k_number']
+      end
+
+      if attributes.key?(:'specific_assay_pma_number')
+        self.specific_assay_pma_number = attributes[:'specific_assay_pma_number']
+      end
+
+      if attributes.key?(:'specific_assay_fda_url')
+        self.specific_assay_fda_url = attributes[:'specific_assay_fda_url']
+      end
+
+      if attributes.key?(:'specific_assay_similarity')
+        self.specific_assay_similarity = attributes[:'specific_assay_similarity']
+      end
+
+      if attributes.key?(:'n_cdx_entries')
+        self.n_cdx_entries = attributes[:'n_cdx_entries']
+      end
+
+      if attributes.key?(:'cdx_diagnostic_names')
+        if (value = attributes[:'cdx_diagnostic_names']).is_a?(Array)
+          self.cdx_diagnostic_names = value
+        end
       end
 
-      if attributes.key?(:'assay_provider_class_source')
-        self.assay_provider_class_source = attributes[:'assay_provider_class_source']
+      if attributes.key?(:'n_clia_certificates')
+        self.n_clia_certificates = attributes[:'n_clia_certificates']
       end
 
-      if attributes.key?(:'assay_provider_class_decided_at')
-        self.assay_provider_class_decided_at = attributes[:'assay_provider_class_decided_at']
+      if attributes.key?(:'clia_match_rung')
+        self.clia_match_rung = attributes[:'clia_match_rung']
       end
     end
 
@@ -366,9 +572,12 @@ module PharmaObservatory
           biomarker_id == o.biomarker_id &&
           biomarker_display_name == o.biomarker_display_name &&
           gene_resolution_status == o.gene_resolution_status &&
-          company_name_key == o.company_name_key &&
+          provider_key == o.provider_key &&
+          provider_role == o.provider_role &&
           provider_name == o.provider_name &&
           provider_org_id == o.provider_org_id &&
+          provider_org_match_tier == o.provider_org_match_tier &&
+          provider_parent_org_id == o.provider_parent_org_id &&
           provider_company_id == o.provider_company_id &&
           provider_company_name == o.provider_company_name &&
           provider_group_id == o.provider_group_id &&
@@ -386,9 +595,26 @@ module PharmaObservatory
           most_recent_pmid == o.most_recent_pmid &&
           most_recent_title == o.most_recent_title &&
           meets_curated_threshold == o.meets_curated_threshold &&
-          assay_provider_class == o.assay_provider_class &&
-          assay_provider_class_source == o.assay_provider_class_source &&
-          assay_provider_class_decided_at == o.assay_provider_class_decided_at
+          regulatory_evidence_kind == o.regulatory_evidence_kind &&
+          has_fda_record_for_biomarker == o.has_fda_record_for_biomarker &&
+          regulatory_evidence_reasons == o.regulatory_evidence_reasons &&
+          n_fda_ivd_510k == o.n_fda_ivd_510k &&
+          n_fda_ivd_pma == o.n_fda_ivd_pma &&
+          fda_company_match_rung == o.fda_company_match_rung &&
+          n_fda_analyte_510k == o.n_fda_analyte_510k &&
+          n_fda_analyte_pma == o.n_fda_analyte_pma &&
+          fda_analyte_product_codes == o.fda_analyte_product_codes &&
+          fda_analyte_fda_url == o.fda_analyte_fda_url &&
+          specific_assay_matched == o.specific_assay_matched &&
+          specific_assay_device_name == o.specific_assay_device_name &&
+          specific_assay_k_number == o.specific_assay_k_number &&
+          specific_assay_pma_number == o.specific_assay_pma_number &&
+          specific_assay_fda_url == o.specific_assay_fda_url &&
+          specific_assay_similarity == o.specific_assay_similarity &&
+          n_cdx_entries == o.n_cdx_entries &&
+          cdx_diagnostic_names == o.cdx_diagnostic_names &&
+          n_clia_certificates == o.n_clia_certificates &&
+          clia_match_rung == o.clia_match_rung
     end
 
     # @see the `==` method
@@ -400,7 +626,7 @@ module PharmaObservatory
     # Calculates hash code according to all attributes.
     # @return [Integer] Hash code
     def hash
-      [route_key, biomarker_key, biomarker_id, biomarker_display_name, gene_resolution_status, company_name_key, provider_name, provider_org_id, provider_company_id, provider_company_name, provider_group_id, provider_group_name, rx_matched, rx_provider_id, rx_provider_name, rx_provider_slug, has_clinical_validation, has_analytical_validation, n_papers, n_dated_papers, n_undated_papers, most_recent_published_at, most_recent_pmid, most_recent_title, meets_curated_threshold, assay_provider_class, assay_provider_class_source, assay_provider_class_decided_at].hash
+      [route_key, biomarker_key, biomarker_id, biomarker_display_name, gene_resolution_status, provider_key, provider_role, provider_name, provider_org_id, provider_org_match_tier, provider_parent_org_id, provider_company_id, provider_company_name, provider_group_id, provider_group_name, rx_matched, rx_provider_id, rx_provider_name, rx_provider_slug, has_clinical_validation, has_analytical_validation, n_papers, n_dated_papers, n_undated_papers, most_recent_published_at, most_recent_pmid, most_recent_title, meets_curated_threshold, regulatory_evidence_kind, has_fda_record_for_biomarker, regulatory_evidence_reasons, n_fda_ivd_510k, n_fda_ivd_pma, fda_company_match_rung, n_fda_analyte_510k, n_fda_analyte_pma, fda_analyte_product_codes, fda_analyte_fda_url, specific_assay_matched, specific_assay_device_name, specific_assay_k_number, specific_assay_pma_number, specific_assay_fda_url, specific_assay_similarity, n_cdx_entries, cdx_diagnostic_names, n_clia_certificates, clia_match_rung].hash
     end
 
     # Builds the object from hash

data/lib/pharmaobservatory/models/biomarkers_row.rb

@@ -94,8 +94,8 @@ module PharmaObservatory
     # Assay-provider suppliers named.
     attr_accessor :n_assay_provider_suppliers
 
-    # Of those, diagnostic providers.
-    attr_accessor :n_diagnostic_provider_suppliers
+    # Of those, providers with an FDA record found for the biomarker (a companion diagnostic, a cleared or approved device the paper names, a cleared or approved IVD under the analyte's product code, or a CLIA-certified lab that ran the test). US only; no record found is not a statement about validation. Null when no assay provider is named for the biomarker.
+    attr_accessor :n_fda_evidence_providers
 
     # Attribute mapping from ruby-style variable name to JSON key.
     def self.attribute_map
@@ -126,7 +126,7 @@ module PharmaObservatory
         :'has_analytical_validation_evidence' => :'has_analytical_validation_evidence',
         :'n_assay_provider_papers' => :'n_assay_provider_papers',
         :'n_assay_provider_suppliers' => :'n_assay_provider_suppliers',
-        :'n_diagnostic_provider_suppliers' => :'n_diagnostic_provider_suppliers'
+        :'n_fda_evidence_providers' => :'n_fda_evidence_providers'
       }
     end
 
@@ -169,7 +169,7 @@ module PharmaObservatory
         :'has_analytical_validation_evidence' => :'Boolean',
         :'n_assay_provider_papers' => :'Integer',
         :'n_assay_provider_suppliers' => :'Integer',
-        :'n_diagnostic_provider_suppliers' => :'Integer'
+        :'n_fda_evidence_providers' => :'Integer'
       }
     end
 
@@ -202,7 +202,7 @@ module PharmaObservatory
         :'has_analytical_validation_evidence',
         :'n_assay_provider_papers',
         :'n_assay_provider_suppliers',
-        :'n_diagnostic_provider_suppliers'
+        :'n_fda_evidence_providers'
       ])
     end
 
@@ -326,8 +326,8 @@ module PharmaObservatory
         self.n_assay_provider_suppliers = attributes[:'n_assay_provider_suppliers']
       end
 
-      if attributes.key?(:'n_diagnostic_provider_suppliers')
-        self.n_diagnostic_provider_suppliers = attributes[:'n_diagnostic_provider_suppliers']
+      if attributes.key?(:'n_fda_evidence_providers')
+        self.n_fda_evidence_providers = attributes[:'n_fda_evidence_providers']
       end
     end
 
@@ -377,7 +377,7 @@ module PharmaObservatory
           has_analytical_validation_evidence == o.has_analytical_validation_evidence &&
           n_assay_provider_papers == o.n_assay_provider_papers &&
           n_assay_provider_suppliers == o.n_assay_provider_suppliers &&
-          n_diagnostic_provider_suppliers == o.n_diagnostic_provider_suppliers
+          n_fda_evidence_providers == o.n_fda_evidence_providers
     end
 
     # @see the `==` method
@@ -389,7 +389,7 @@ module PharmaObservatory
     # Calculates hash code according to all attributes.
     # @return [Integer] Hash code
     def hash
-      [biomarker_id, route_key, biomarker_kind, identity_status, display_name, parent_biomarker_id, gene_symbol, amino_acid_change, target_id, hgnc_id, uniprot_accession, target_protein_name, feature_code, feature_type, evidence_tier, evidence_tier_label, n_fda_cdx_assertions, n_fda_bqp_assertions, n_cancer_actionable_cgi, n_ot_association, n_trial_mention, n_publication_variant_mentions, has_clinical_validation_evidence, has_analytical_validation_evidence, n_assay_provider_papers, n_assay_provider_suppliers, n_diagnostic_provider_suppliers].hash
+      [biomarker_id, route_key, biomarker_kind, identity_status, display_name, parent_biomarker_id, gene_symbol, amino_acid_change, target_id, hgnc_id, uniprot_accession, target_protein_name, feature_code, feature_type, evidence_tier, evidence_tier_label, n_fda_cdx_assertions, n_fda_bqp_assertions, n_cancer_actionable_cgi, n_ot_association, n_trial_mention, n_publication_variant_mentions, has_clinical_validation_evidence, has_analytical_validation_evidence, n_assay_provider_papers, n_assay_provider_suppliers, n_fda_evidence_providers].hash
     end
 
     # Builds the object from hash

data/lib/pharmaobservatory/version.rb

@@ -11,5 +11,5 @@ Generator version: 7.13.0
 =end
 
 module PharmaObservatory
-  VERSION = '0.1.9'
+  VERSION = '0.1.11'
 end

metadata

@@ -1,14 +1,14 @@
 --- !ruby/object:Gem::Specification
 name: pharmaobservatory
 version: !ruby/object:Gem::Version
-  version: 0.1.9
+  version: 0.1.11
 platform: ruby
 authors:
 - Scientist.com
 autorequire:
 bindir: bin
 cert_chain: []
-date: 2026-10-24 00:00:00.000000000 Z
+date: 2026-10-29 00:00:00.000000000 Z
 dependencies:
 - !ruby/object:Gem::Dependency
   name: faraday