Test Ordering Workflow
CDx ordering tooling helps prescribers order the correct validated test, since therapy eligibility depends on the specific assay named in the approved label.
Custom Software
Companion Diagnostics Software Development
Companion diagnostics software connects biomarker testing to therapy eligibility across ordering, result delivery, and prescriber workflow. Because a CDx result determines whether a patient may receive a specific therapy, the software carries regulatory weight: result interpretation stays with the laboratory director or pathologist, and eligibility follows the approved label rather than software logic.
Companion diagnostics sit at an unusual intersection, since the test is regulated as a device while the therapy is regulated as a drug, and their approvals are linked. Taction Software builds companion diagnostics software across ordering, result integration, and eligibility support, with the regulatory boundaries that linkage creates handled explicitly rather than assumed.
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What Is Companion Diagnostics Software
Companion diagnostics software supports the workflow connecting a biomarker test to a therapy whose label requires it: test ordering, specimen tracking, laboratory result delivery, prescriber notification, eligibility documentation, and program analytics. Some components may themselves meet the definition of a medical device, particularly where software interprets or reports patient-specific results influencing treatment. Our work sits within our broader pharma and life sciences practice and connects to precision medicine delivery.
Specimen and Logistics Tracking
Specimen tracking covers collection, shipment, and receipt, where delays directly postpone treatment decisions in time-sensitive oncology contexts.
Laboratory Result Integration
Result integration delivers findings to ordering prescribers, building on our lab information system development work for result routing.
Biomarker Result Reporting
Biomarker reporting presents results with the interpretation the laboratory provides. The pathologist or laboratory director interprets, never the software.
Eligibility Documentation
Eligibility documentation records that required testing occurred, supporting the label requirement without the software determining who qualifies.
Program and Testing Analytics
Testing analytics measure ordering rates, turnaround, and result distribution, informing program decisions made by medical and commercial teams.
Core Companion Diagnostics Services
Our companion diagnostics software services cover ordering platforms, laboratory integration, result delivery, prescriber tooling, and program analytics. The regulatory question we settle first is which components constitute device software, since that determines validation and submission obligations for those elements. Engagements typically open with a review of the CDx approval, the laboratory network, and how results currently reach prescribers. Deliverables are structured so regulatory, medical, and commercial stakeholders can review independently.
01
Ordering Platform Development
We build ordering platforms connecting prescribers to validated testing, with clear identification of which assay the approved label requires.
02
Laboratory Network Integration
Integration spans laboratory systems across a testing network, handling the interface variability that multi-lab CDx programs always encounter.
03
Result Delivery Systems
Result delivery reaches prescribers reliably through EHR integration or direct channels, since undelivered results delay treatment decisions.
04
Molecular and Pathology Context
Where molecular or image-based testing is involved, our pathology AI work covers digital pathology integration patterns.
05
Precision Medicine Integration
CDx sits within broader precision medicine delivery, connecting with our precision medicine platform work on genomic workflow.
06
Regulatory Classification Support
Where components meet device definitions, our FDA SaMD compliance services cover classification and validation requirements.
Benefits of Companion Diagnostics Software
The benefits concentrate in testing rate visibility, faster result turnaround, and documented eligibility. CDx programs frequently underperform because eligible patients are never tested, and that gap is usually operational rather than clinical: prescribers do not know which test to order, or results take too long to influence the treatment decision. We publish no figures on testing rates, turnaround, or therapy uptake, because those depend entirely on the product, testing network, and clinical setting.
Clearer Test Ordering
Explicit identification of the required assay reduces incorrect test ordering, which is a common and largely invisible failure in CDx programs.
Faster Result Turnaround
Logistics tracking and result routing reduce delay between specimen collection and the prescriber receiving an actionable finding.
Visible Testing Gaps
Testing analytics show where eligible patients are not being tested, which is where most CDx programs lose patients before therapy is ever considered.
Documented Eligibility
Structured eligibility records support the label requirement and reimbursement documentation without the software determining qualification.
Better Trial Connection
Result data supports trial identification, connecting with AI clinical trial matching where biomarker criteria apply.
Program Performance Insight
Aggregate data informs program decisions on laboratory network, education, and support, made by medical and commercial leadership.
Our Companion Diagnostics Process
We deliver companion diagnostics software projects in gated phases so regulatory, medical, and commercial stakeholders approve direction before engineering cost accumulates. Discovery establishes the approved CDx and therapy labeling, the testing network, and which software components may constitute device software. That classification question comes first because it determines validation obligations for those components and materially affects timeline. Result delivery reliability receives particular attention, since undelivered results have direct clinical consequence.
Discovery and Regulatory Classification
Discovery reviews the approved labeling and assesses which components meet device definitions, since that determines validation and submission obligations.
Testing Network Assessment
We evaluate the laboratory network and interface capability, which varies considerably and determines integration effort more than platform design does.
Ordering Workflow Design
We design ordering with prescribers, since assay specificity confusion is a leading cause of incorrect testing and consequent eligibility delay.
Result Delivery Engineering
Delivery reliability is engineered with confirmation and exception handling, because a result that fails to arrive delays a treatment decision silently.
Validation Where Applicable
Components meeting device definitions follow validation protocols with documented testing appropriate to their regulatory classification.
Rollout and Ongoing Support
Rollout expands by region or laboratory with turnaround monitoring, program analytics, and continuing support as networks and labeling change.
Technology and Compliance
Companion diagnostics software operates at a regulatory intersection. The diagnostic is an IVD, typically approved alongside the therapy, and software reporting patient-specific results influencing treatment may itself be a regulated device. Laboratory operations fall under CLIA, and result data is PHI handled under HIPAA where the software operates in a covered entity or business associate context. Taction holds ISO 27001 certification. The boundary that matters most is interpretation: the laboratory director or pathologist interprets results, and software presents rather than concludes.
Device Classification Assessment
Software reporting patient-specific results may constitute a regulated device, which we assess during discovery rather than assuming exemption.
Interpretation Boundary
Result interpretation belongs to the laboratory director or pathologist. Software presents findings and does not generate diagnostic conclusions.
Label-Driven Eligibility
Eligibility follows approved labeling. Software documents that required testing occurred rather than determining which patients qualify for therapy.
CLIA and Laboratory Requirements
CLIA governs laboratory operations and result reporting, informing how results are transmitted, documented, and amended when corrections occur.
PHI Handling
Result data is PHI in clinical contexts, requiring HIPAA-aligned controls. Our HIPAA compliance practice defines them.
Deployment Security
Deployments run in your cloud tenancy or hybrid, with network segmentation, signed container images, and documented penetration testing before release.
Why Choose Taction Software
Taction Software was founded in 2013 and has spent over 12 years building healthcare and life sciences software, delivering more than 200 healthcare projects from four US offices in Chicago, Cheyenne, Austin, and Sacramento, with ISO 27001 certification. Our relevant strength here is that CDx software spans pharma, laboratory, and provider environments simultaneously, and we build in all three. Vendors from one side alone tend to underestimate the constraints on the others. Our leadership brings more than 20 years of personal experience in the field.
01
Cross-Environment Experience
We build pharma, laboratory, and provider systems, which is what CDx workflow spans and what single-environment vendors underestimate.
02
Regulatory Classification Discipline
We assess device classification early, since components reporting patient-specific results carry obligations that surprise programs late in development.
03
Established Healthcare Focus
Founded in 2013, we have concentrated on healthcare and life sciences rather than treating them as one vertical among several.
04
Regulated Product Experience
We delivered the FDA-registered applications Revive Ease and PainKare, so design controls and validation documentation are established practice.
05
Result Delivery Rigor
We engineer delivery confirmation and exception handling, since a silently undelivered result delays treatment without anyone noticing.
06
Certified Security Posture
ISO 27001 certification means security controls are documented and auditable, supporting sponsor and laboratory vendor assessment efficiently.
Pricing
Companion diagnostics software pricing depends on scope, laboratory network size, whether components require device validation, and result delivery complexity. Device classification is the largest swing factor, since validated components carry documentation obligations that non-device tooling does not. Discovery produces an itemized, fixed-scope estimate with phase-level breakdown after regulatory classification is assessed. Laboratory interface fees, cloud infrastructure, and third-party licensing are separate from engineering.
MVP or Single Module
An MVP covering ordering workflow or result delivery for one laboratory typically runs $40,000 to $80,000.
Full Platform Build
A full platform with ordering, logistics tracking, multi-lab integration, and program analytics typically falls between $80,000 and $200,000.
Enterprise Deployment
Enterprise engagements covering co-development programs, device-classified components, and global laboratory networks start at $200,000.
Discovery Phase Scoping
Discovery is a paid, time-boxed phase producing an itemized estimate, architecture plan, and regulatory classification assessment.
Cost Drivers to Expect
Device classification, laboratory network size, EHR integration breadth, and validation scope are the largest variables, identified during discovery.
Ongoing Support Costs
Post-launch network expansion, labeling changes, revalidation, and support are quoted separately as a retainer sized to testing volume.
Get Started
If you are evaluating companion diagnostics software for test ordering, result delivery, eligibility documentation, or program analytics, the fastest next step is a discovery call with our team. We will assess regulatory classification, review your laboratory network, and return an itemized, fixed-scope estimate. Contact us to schedule that conversation.
FAQs
Frequently Asked Questions
Program and regulatory leaders evaluating companion diagnostics software usually ask whether their software is a device, how eligibility is handled, and why testing rates underperform. The answers below reflect how we scope these projects.
It may be, particularly where it reports or interprets patient-specific results influencing treatment. Ordering logistics and program analytics generally are not. We assess classification during discovery rather than assuming, because discovering a device obligation late in development is expensive and delays launch.
No. Eligibility follows the approved labeling, and the software documents that required testing occurred and what the laboratory reported. Interpretation belongs to the laboratory director or pathologist, and the treatment decision belongs to the prescriber. Software that concluded eligibility would be making a clinical determination.
Usually operational rather than clinical. Prescribers may not know which specific assay the label requires, specimens take too long to reach the laboratory, or results arrive after the treatment decision was already made. Testing analytics identify which of these applies in your program.
An MVP covering ordering or result delivery runs $40,000 to $80,000. A full platform typically falls between $80,000 and $200,000. Enterprise co-development programs with device-classified components start at $200,000. Device classification is the largest cost variable.
Yes, and most programs need it. Laboratory interfaces vary considerably in capability and standard conformance, so we build adapters where necessary and standardize result presentation so prescribers see consistent output regardless of which laboratory performed the test.
Where germline testing is involved, we build referral and documentation workflow supporting counseling requirements. The software does not deliver counseling or interpret genetic implications, which requires qualified professionals, but it can ensure the referral pathway exists and is documented.