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BeanStock Ventures

BeanStock Ventures has over 20 years experience developing medical device and clinical applications for various marketing which includes connectivity and participating in standards committees. We are a FDA recognized third party approver organization - so we understand what is takes to clear a medical device or SaMD (outside of EUA). From a company perspective we are developing a sample to answer platform to service our diverse client based, specifically in the genomics space, so we will...

Clinical Sample to Answer Platform - multi-modality

BeanStock Ventures is developing a sample to answer platform focused on taking in test and assay data (PCR, NGS, Microarray) providing a standardized interface for native data upload , processing, storage, comparison, review and reporting.

There are currently patient portal that allow patients to view results, this information already has their details. If we want to consider home testing with self reporting that is a bit different. Is that the main intent of this effort? If so we could develop a phone image capture of the lateral flow device and determine if they are positive or negative and sent via wifi or cellular, but them how do we handle rural areas (no smart phone)that's always a challenge. Is this most beneficial?

Typically in healthcare we rely on IHE (with Hl7) to take into account DICOM, HL7, SNOMED etc, without a COVID specific working group it's difficult to get community/industry consensus. Right now I think a good starting point is to provide an API that EHR/EMR and LIMS can connect to and leverage the work HL7 and IHE is doing (see below), as you know until there is some working group driving the standard, the EMR/EHR and LIMS work together to provide connectivity. At least with our platform our interface for EMR and LIMS with be standard per below and we can help drive standardization once we know exactly the major workflows and required and options data elements.
https://www.ihe.net/
For LIMS see:
https://www.ihe.net/resources/technical_frameworks/#laboratory
For public health see:
https://www.ihe.net/resources/technical_frameworks/#qrph
For COVID see:
https://blog.hl7.org/topic/covid-19

I prefer 30th, midnight - many of us are on travel for the holidays and 29th is a Sunday :)

1) Relies on LIMS or LIS, but will have API interface to obtain info needed for analysis, 2) Will be covered, need to tie patient information info the final report by sourcing from LIMS, 3) Yes - EMR/EHR, etc, 4) Yes

Pre-analytical if referring to accessioning will be covered by LIMS integration. Analytical is intended to be integrated. Post analytical will include QC step for approval or lab review prior to be sent to the patient or clinician. Report will comply with CLIA and access controls will be in place to protect patient privacy during analysis using an unique id.

I'm thinking there is value in correlating your detection with the actual positive/negative test results, either to validate your algorithm or improve and refine (reduce false pos/neg).

It would be great if this data could be correlated with the test results, our platform will host the test results.

Shawnnah Monterrey

San Diego, United States

Joined this community on Nov 13, 2020

Bio We combine a client-friendly approach with years of experience and proven methodologies. Additionally, as a diverse, female-led company working in technology, we are also able to offer a unique perspective on your products and process.

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Shawnnah's profile

Activity for Shawnnah Monterrey

BeanStock Ventures

BeanStock Ventures

Clinical Sample to Answer Platform - multi-modality

Clinical Sample to Answer Platform - multi-modality

Clinical Sample to Answer Platform - multi-modality

Vote on Nov 29 Midnight Extension

Clinical Sample to Answer Platform - multi-modality

Clinical Sample to Answer Platform - multi-modality

Signal Detection in Patient Level Data

Signal Detection in Patient Level Data

Shawnnah Monterrey

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