Diagnostics · Blood cancer genomics
Data Driven Bioscience
A Durham company that sells hospital laboratories a kit for reading a tumor’s DNA and RNA in a single preparation, on the sequencer the lab already owns. The clinical validation was published in January 2026. The capital behind it is almost invisible.
A week of waiting, ten minutes away
In 2012 a patient sat at Duke University Hospital for nearly a week while the laboratory worked out whether he had lymphoma. The oncologist reviewing him kept returning to one question. “What’s taking so long?”
About a ten minute walk from that bed, Sandeep Dave’s research laboratory was routinely reading the complete genomic makeup of a tumor in a day or two. Same instruments, same chemistry. The delay lived in how clinical laboratories are organized, not in what sequencing can do.
“It was very frustrating that the technology existed in my lab but could not be immediately applied to patients,” Dave told Duke’s medical school in 2021.
Six years after that patient, he incorporated a company to close the gap. Data Driven Bioscience went through Y Combinator in the summer of 2018 on a one line pitch it still uses: cancer diagnosis 10X faster, 10X cheaper.
Two assays, and the send out
A modern blood cancer workup leans on two sequencing assays. DNA sequencing finds mutations, copy number changes and translocations. RNA sequencing finds gene expression and fusions. In most laboratories they are separate kits, separate preparations and separate timelines.
The company’s own grant abstract at the National Cancer Institute puts it flatly. The assays are “complex and usually separate, with different workflows and timelines for sample preparation.” The analysis is “complex and difficult to implement.” Turnaround “typically stretches over a week.”
Most community laboratories answer that by shipping the sample to a reference lab. Duoseq proposes the opposite: one preparation that builds both libraries, a panel of 475 recurrently altered genes, and cloud software that reads the run, so any laboratory with an Illumina sequencer keeps the work in house.
The trick is chemical. In most cancer biopsies RNA is close to 80 percent of the total nucleic acid and DNA only 20 percent. Duoseq adds interfering factors that make the ligation of sequencing barcodes to RNA much less efficient than to DNA, inverting the proportions so both libraries come out usable.
A computer scientist who became an oncologist
Dave majored in computer science and wrote his senior thesis on artificial intelligence, then walked away from it. “I came away very unhappy at what passed for artificial intelligence,” he told Duke in 2022. He went to Northwestern instead, collecting a master’s in bioengineering, an MD and an MBA. A fellowship at the National Institutes of Health put him in Louis Staudt’s laboratory.
He joined Duke in 2007 and was named the Wellcome Clinical Distinguished Professor of Medicine in May 2022. He directs the Molecular Genetics and Genomics Program at the Duke Cancer Institute and runs the Atlas of Blood Cancer Genomes, a consortium of 25 academic institutions that has collected roughly 15,000 tumor samples while trying to map every one of the more than 100 blood cancer types. That atlas is why the company exists. The building blocks it produced are what the diagnostic reads.
What shipped, and when
The trademark file is the cleanest record of the early years. Data Driven Bioscience, a Delaware corporation then at 701 West Main Street in Durham, claimed first use of the DUOSEQ mark on June 14, 2018 and filed on March 13, 2019. On June 8, 2020 it was declared abandoned for want of a statement of use. On July 29, 2020 the company petitioned to revive it and filed the statement, citing first use in commerce on July 15, 2020. Revival was granted the same day.
Validation then followed in public, in order. At ASCO in 2022, 111 formalin fixed lymphoma cases across three CLIA laboratories. At ASCO in 2023, 54 clinical cases measured against a FoundationOne Heme comparison. At the American Society of Hematology in December 2023, a full analytical validation carried out at two CLIA laboratories plus 153 clinical specimens. Then, in January 2026, the peer reviewed paper.
In between, the National Cancer Institute put money in: a Phase I award of $300,682 and a Phase II award of $1,022,841 both starting January 1, 2025, with a second Phase II year of $1,022,841 recorded for fiscal 2026. The company now trades as Duoseq. In March 2026 the Northwestern alumni magazine reported that several hospitals were using the test and that in its first year it had returned results on about 2,000 patient samples.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| Peer reviewed validation | Journal of Molecular Diagnostics, January 2026, validated in parallel at two clinical institutions. Limit of detection 5 percent variant allele frequency for single nucleotide variants, 10 percent for indels, 20 percent or greater tumor purity for structural variants. 197 formalin fixed specimens, accuracy above 95 percent for all three variant classes. | Public record |
| ASH 2023 | Abstract 3670. Concordance with commercial kits of 99.4 percent for DNA variants and R squared of 0.97 for RNA expression. On 153 specimens: 98 percent for single nucleotide variants, 96 percent for indels, 95 percent for translocations, 100 percent for Epstein Barr virus status. | Public record |
| ASCO 2022 and 2023 | 111 lymphoma cases across three CLIA laboratories in 2022, accuracy 95.9 percent for mutations. 54 cases against FoundationOne Heme in 2023, 98 percent sensitivity for single nucleotide variants. | Public record |
| Federal grants | NCI awards 1R43CA298055-01, 2R44CA298055-02 and 5R44CA298055-03, totalling $2,346,364, running to August 31, 2027. | Public record |
| Trademark | USPTO serial 88338647, DUOSEQ, for apparatus for DNA and RNA testing. Abandoned June 8, 2020, revived July 29, 2020. | Public record |
| Biopharma use | AUM Biosciences named a “DuoSeq-based” companion diagnostic in its 2023 prospectus filed with the SEC. | Public record |
| Regulatory footprint | No 510(k), premarket approval, device registration or registered clinical trial found as of September 22, 2026. | Not found |
| Own laboratory | No CLIA certificate and no National Provider Identifier found under the company name. | Not found |
| Turnaround time | The website says two days and under 48 hours. The abstracts and the grant abstract say 2 to 3 days. | Differs from the record |
| Detection threshold | ASCO 2023 reports 10 percent tumor purity for structural variants. ASH 2023 and the 2026 paper both report 20 percent or greater. | Reports differ |
| Customers | About 2,000 samples in the first year and several hospitals using the test. No customer named anywhere in public. | Company-stated |
Read plainly: the analytical evidence is unusually complete and unusually public, and it now clears the bar that matters most, a peer reviewed clinical validation in a diagnostics journal. What is missing is the commercial side. No named customer, no published price, no coverage decision on record, no laboratory of its own, and no regulatory filing of any kind. The test is real. The business is still a claim.
What to watch
- Whether any hospital puts its name to Duoseq in public. The website testimonials are unattributed.
- MolDX. The company offers submission support, but no coverage determination naming Duoseq has surfaced.
- The Phase II grant, which runs to August 31, 2027.
- Whether the AUM Biosciences companion diagnostic plan survived that company’s 2023 merger.
- A first SEC Form D. Eight years in, there is still none.
In their words
“It was very frustrating that the technology existed in my lab but could not be immediately applied to patients.”
Sandeep Dave, founder and CEO, Duke University School of Medicine, 2021 · Independent
“Waiting is agony for the patients and their families, and it is equally uncomfortable for treating oncologists who cannot begin treatment until the diagnosis is nailed down.”
Sandeep Dave, Northwestern Feinberg magazine, 2026 · Independent
“The technology already exists to make these connections in less than two days.”
Sandeep Dave, Duke University School of Medicine, 2021 · Independent
“It is almost 10 times faster, and it can be significantly cheaper because you have a single workflow that replaces many other workflows.”
Sandeep Dave, Northwestern Feinberg magazine, 2026 · Independent
“Once these genetic factors are understood, and the cost of sequencing is low, it will become standard of care.”
Nelson Chao, MD, MBA, Duke, 2021 · Independent
“In the time it takes us to FedEx a sample to another lab, we have comprehensive NGS results in hand.”
Unattributed testimonial, Duoseq website, 2026 · Company site
“These results establish Duoseq as a genomic profiling tool for blood cancers that can enable laboratories to provide critical diagnostic information in a time- and cost-effective manner.”
Journal of Molecular Diagnostics, January 2026 · Public record
Related companies
Sources
- Public recordClinical Validation of Duoseq, a Novel Assay for Clinical DNA and RNA Sequencing
- Public recordAnalytical and Clinical Validation of Duoseq, abstract 3670
- Public recordDevelopment and validation of Duoseq as a novel diagnostic and companion assay
- Public recordEstablishing clinical performance characteristics for Duoseq
- Public recordNIH RePORTER 1R43CA298055-01, 2R44CA298055-02, 5R44CA298055-03
- Public recordUSPTO trademark file 88338647, DUOSEQ
- Public recordAUM Biosciences Limited prospectus, Form 424B3
- Public recordNo FDA or trial records, no SEC registrant, no Form D
- IndependentBreaking Down Blood Cancers
- IndependentGetting Personal with Blood Cancers
- IndependentMeet Dr. Sandeep Dave: New Wellcome Clinical Distinguished Professor
- IndependentCompany profile, total raised and investor list
- IndependentDuoseq company profile, deal history and investors
- IndependentPortfolio entries listing Data Driven Bioscience
- CompanyDuoseq website: home, pathologists and biopharma pages
- CompanyExhibitor listing, booth 1223, with Durham address
- CompanyCompany and jobs pages
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
