Consumer diagnostics · Male fertility
Legacy
A mail-in kit that tests sperm, and then freezes it, without a clinic visit. Seven years in, it holds one active FDA tissue establishment registration, a CLIA certificate, and a New York state approval for two of its tests. The study that would show how its samples perform in IVF started in 2026.
A cup, a vial of pink fluid, and an overnight courier
The box holds a sterile cup, an insulated zippered container the company calls a vault, two padlocks, and a small vial of pink liquid. You produce a sample at home, mix in the liquid, lock the vault, and hand it to a courier. The instructions are specific: abstain two to five days, ship the same day, Monday through Thursday, because nobody is at the laboratory on the weekend.
Next morning the sample lands at an andrology laboratory in Hoboken, New Jersey. A technician replenishes the transport media, centrifuges the sample, and loads a slide into a computer-assisted sperm analysis system for count, concentration and motility. Morphology is still judged by a person at a microscope. Results appear on a phone inside 48 hours. If you paid to freeze, a cryoprotectant goes in, the vials go to minus 196 degrees Celsius by slow freeze, and a portion is thawed at once to check the sperm survived. Then the vials are split and shipped to more than one storage site.
The half of the problem that rarely gets tested
Male factor contributes to roughly half of infertility cases, and it is the cheaper half to measure: a microscope, a counting chamber, a trained technologist. Yet the test gets skipped constantly, for logistical and social reasons rather than clinical ones. A sample has to reach a laboratory within about an hour of ejaculation, which means a collection room down a corridor.
Mail-in testing attacks one stage of that, the one where a man has to walk into a building. It creates a new problem. Motility falls the moment a sample leaves the body, so every mail-in company sells a measurement taken hours after the thing it measures.
Hot tea, and a friend with cancer
Khaled Kteily studied public policy at the Harvard Kennedy School and worked as a healthcare consultant at Oliver Wyman, then at the World Economic Forum. Two events appear in his telling. In the Hacker News launch post he wrote that an accident left second degree burns on his thighs from very hot tea, and that a friend’s cancer diagnosis and pre-chemotherapy sperm freezing sent him to a clinic himself. In a Starter Story interview the friend comes first and the burns do not appear. Both accounts are his. The company came out of the Harvard Innovation Labs, announced a $1.5 million round led by Bain Capital Ventures in June 2019, and went through Y Combinator that summer.
Cambridge, then Boston, then New York, and a laboratory in Hoboken
The datelines track the company. Cambridge in 2019. Boston in May 2022, for a $25 million Series B led again by Bain Capital Ventures, with FirstMark Capital, Section 32, TQ Ventures and Valor Equity Partners, and a cap table that included Justin Bieber, The Weeknd, Orlando Bloom and DJ Khaled. Six weeks later the Boston Business Journal reported layoffs. New York from late 2023.
Federal records point somewhere else again. The National Provider Identifier 1366068454 lists GIVE LEGACY, INC. at 22 Hudson Pl Fl 4, Hoboken, New Jersey, as a clinical medical laboratory. The FDA tissue establishment register agrees: of four Give Legacy entities on file, only the New Jersey one is currently listed as Registered.
The military line
Infertility runs higher among veterans of the post-2001 wars than among civilians. The Pentagon announced a sperm and egg freezing benefit in 2016 and never launched it. Nonprofits filled the gap, and Legacy attached itself to them early: the Military Family Building Coalition and its Tadpole Project for Naval Special Warfare, the Green Beret Foundation, then a subcontract to the Department of Veterans Affairs through Veterans Evaluation Services, clearing a backlog of semen analyses needed for disability exams. A Department of Defense pilot opened on September 14, 2026, reimbursing eligible members up to $500 a year for sperm preservation.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA tissue establishment registration | An FDA HCTERS query for “give legacy” on Sep 23, 2026 returned four establishments. Hoboken, NJ (FEI 3024743004): Registered. New York, San Mateo and San Antonio: Inactive. The matching provider record, NPI 1366068454, lists GIVE LEGACY, INC. in Hoboken as a clinical medical laboratory. | Public record |
| CLIA certification | The FAQ states: “Yes, Legacy’s andrology lab is Clinical Laboratory Improvement Amendments (CLIA) certified. Our CLIA ID is 31D2285605.” Releases describe a “CLIA-certified, high-complexity andrology lab.” CLIA governs how a laboratory operates, not whether a test is accurate. | Company-stated |
| How those credentials are described | A company explainer says its laboratories and storage sites “have been rigorously screened for quality and high standards by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC)” and calls them FDA and CLIA certified. CLIA certificates come from CMS; FDA registers tissue establishments rather than certifying laboratories. | Looser than the record |
| New York State review | Release of Jun 24, 2026: the state Clinical Laboratory Evaluation Program approved two laboratory developed tests, semen analysis and DNA fragmentation, for at-home collection. The release adds that approval “does not constitute review or approval of any specimen collection device used in connection with the test” nor of the machine learning software in it. | Company release |
| Peer-reviewed work on the kit | Alexander et al, Am J Mens Health, Dec 2025: 30 participants, 60 samples, five timepoints to 30 hours. A model predicting baseline progressive motility from delayed data reported r = .86 and an intraclass correlation of .74. Two authors are Legacy employees, two are advisors. Four further papers use the Legacy dataset (513 men, 5,822 men, 3,469 samples), all observational. | Public record |
| Independent validation of mail-in analysis | Racicot et al, F S Rep, Dec 2024, validated a service run by Quest Diagnostics and ReproSource, not by Legacy. Under real shipment (n = 232), coefficients of variation were 15% for motility and 27% for concentration, concordance 86% and 93.1%, less variable than between-laboratory proficiency testing. | Public record |
| Independent view of the category | Ernandez et al, Andrology, Nov 2025, reviewed 20 direct-to-consumer products. “Only 25% were validated among subfertile men.” None highlighted the need for partner evaluation. | Public record |
| Device clearance and trials | No 510(k), PMA or ClinicalTrials.gov registration for this company. The only 510(k) a name search returns, K130942, belongs to Legacy Medical, Inc., a disposable blood pressure cuff. | Not found |
| Volume and storage | Jul 2024: “More than 25,000 sperm samples have been analyzed”. The 2026 site: “We’ve tested more than 75,000 semen samples, and more than 25,000 are stored in our secure facilities.” Vials are “split between 2 separate CLIA-registered labs”, unnamed. | Company-stated |
Read plainly: the operating credentials are real and checkable, and the New York approval is the most demanding review any at-home semen test in the United States has cleared. What is not on the record is how a sample that spent a night in a truck performs in an IVF or IUI cycle. Legacy says so itself. Announcing the Sperm Study, it wrote that work to date has “largely enrolled normozoospermic men only, relied on courier-transported rather than real-world-shipped specimens, and focused on short-term motility and concentration as primary endpoints.” That fits the evidence base, including the company’s own 30-person paper.
What to watch
- Results from the Sperm Study, announced May 2026 with more than $1 million behind it, up to 250 participants. Whether it appears on a public trials registry is itself a signal.
- Whether New Jersey stays the only active FDA registration as storage grows.
- Named storage partners. Multi-site storage is the core safety claim and the sites are unnamed.
- Uptake of the Defense Department pilot, and whether the $500 cap moves.
- Price. The basic analysis went from $295 to $145 in April 2026, a volume bet against Ro and Fellow Health.
In their words
“We use a transport medium that keeps sperm alive for up to 48 hours during transit.”
Khaled Kteily, founder and CEO, Launch HN, July 2020 · Founder
“you will never be able to bring risk down to zero”
Khaled Kteily, on cryostorage failure modes, Hacker News, July 2020 · Founder
“We’re not here to move fast and break things, but rather, to build a company that will be the market leader in 50- or 100-years’ time.”
Khaled Kteily, seed round release, June 2019 · Company release
“New York is arguably the most rigorous state-based evaluation of laboratory testing methodology in the country,”
Scott Lundy, MD, PhD, chief medical officer, June 2026 release · Company release
“Military life is specifically challenging for coital reproduction.”
Katy Bell Hendrickson, cofounder, Military Family Building Coalition, to Military.com, 2022 · Independent
“DTC products inconsistently provide clinical recommendations in accordance with guidelines.”
Ernandez, Cook, Berk, Berger and Kathrins, Brigham and Women’s Hospital, Andrology, 2025 · Peer reviewed
“DTC semen analysis and cryopreservation can enhance convenience and early engagement but should complement rather than replace standard evaluation.”
Shin and Kathrins, Current Urology Reports, February 2026 · Peer reviewed
Related companies
Sources
- Public recordFDA HCTERS query, give legacy
- Public recordNPPES NPI 1366068454
- Public recordFresh and delayed analysis, at-home collection kit
- Public recordValidation of a mail-in delayed semen analysis protocol
- Public recordDirect-to-consumer semen analysis products
- IndependentNonprofits Are Filling a Void of Fertility Help
- IndependentTech firms court demand for male fertility services
- IndependentA cold reach-out from a VC algorithm
- IndependentGive Legacy lays off workers after $25M round
- IndependentDoD to launch pilot to freeze sperm, eggs
- CompanyNew York State CLEP approval, two tests
- CompanyLegacy launches $1M Sperm Study
- CompanyLegacy secures $25M Series B
- CompanyLegacy site: how it works, FAQ, military, storage
- FounderLaunch HN: Legacy (YC S19)
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
