SBIR-STTR Award

Low-Cost, Portable and Automated Semen Analysis Using Computational Microscopy for Home-Based Testing of Male Wellness and Fertility
Award last edited on: 5/14/2020

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$1,724,511
Award Phase
2
Solicitation Topic Code
NICHD
Principal Investigator
Maxim Batalin

Company Information

Lucendi Inc

570 Westwood Plaza Building 114 Room 6350
Los Angeles, CA 90095
   (858) 405-8319
   info@lucendi.org
   www.lucendi.org
Location: Single
Congr. District: 33
County: Los Angeles

Phase I

Contract Number: 1R44HD093493-01
Start Date: 9/18/2017    Completed: 3/18/2018
Phase I year
2017
Phase I Amount
$224,831
One of the most significant events in our lives is the birth of a child. At the same time, on average 20% of couples find difficulties conceiving within the first year of trying. In our society, historically, fertility issues are mostly associated with females' health. However, in 40%-50% of these cases male fertility issues may be at the source of the problem, while, typically, are much easier to treat. The fundamental evaluation of male fertility in the clinical laboratory begins with sperm characterization, where the golden standard is to use a benchtop microscope (manually) and/or a computer-assisted automated semen analysis (CASA) system. Though, partially due to cost and partially due to social stigma associated with clinical evaluation or treatment, male infertility often stays undetected. This has generated a demand for inexpensive in-home sperm evaluation kits. However, there is currently no product on the market that offers in-home and quantitative measurement of sperm count and motility – parameters vital for interpretation of semen quality. This proposal aims to develop and commercialize a Lucendi Semen Performance Analytics (Lucendi SPA) platform. Lucendi SPA will be a rapid (

Public Health Relevance Statement:
Approximately 20% of couples find difficulties conceiving within the first year of trying, and in 40%-50% of these cases male fertility issues may be at the source of the problem. However, partially due to cost and partially due to social stigma associated with clinical evaluation or treatment, male infertility often stays undetected. This proposal aims to develop and commercialize a Semen Performance Analytics (SPA) platform that will be an in-home, rapid (

Project Terms:
Affect; Algorithmic Analysis; Algorithms; animal breeding; Area; base; Birth; cell motility; Characteristics; Child; Clinic; Clinical; Clinical Treatment; Clinical Trials; Collaborations; Collection; Companions; Computer Assisted; cost; cost effective; Couples; Custom; density; design; Detection; Development; Drug or Chemical; Evaluation; Event; Farming environment; Feedback; Fertility; Gold; graphical user interface; Head; Health; healthy lifestyle; high throughput analysis; Home environment; Human; Image; Image Analysis; imaging platform; improved; Infertility; Internet; intrauterine insemination; Laboratories; Lasers; lens; Life Style; light weight; male; Male Infertility; Manuals; Measurement; Measures; meetings; Microscope; Microscopic; Microscopy; mobile application; Modality; Monitor; Motion; novel; Optics; Performance; Phase; portability; Process; prototype; Reader; Recommendation; Research; research clinical testing; Resolution; response; Running; Sampling; Secure; Seminal fluid; sensor; social stigma; Societies; Source; Speed; sperm analysis; Sperm Banks; sperm cell; Sperm Count Procedure; Sperm Head; Sperm Motility; sperm quality; statistics; Suction; Suggestion; System; Systems Analysis; Tail; Technology; Testing; Time; TimeLine; Training; Update; Validation; Variant; Vasectomy; web app; Women's Health

Phase II

Contract Number: 4R44HD093493-02
Start Date: 8/1/2018    Completed: 7/31/2020
Phase II year
2018
(last award dollars: 2019)
Phase II Amount
$1,499,680

One of the most significant events in our lives is the birth of a child. At the same time, on average 20% of couples find difficulties conceiving within the first year of trying. In our society, historically, fertility issues are mostly associated with females' health. However, in 40%-50% of these cases male fertility issues may be at the source of the problem, while, typically, are much easier to treat. The fundamental evaluation of male fertility in the clinical laboratory begins with sperm characterization, where the golden standard is to use a benchtop microscope (manually) and/or a computer-assisted automated semen analysis (CASA) system. Though, partially due to cost and partially due to social stigma associated with clinical evaluation or treatment, male infertility often stays undetected. This has generated a demand for inexpensive in-home sperm evaluation kits. However, there is currently no product on the market that offers in-home and quantitative measurement of sperm count and motility – parameters vital for interpretation of semen quality. This proposal aims to develop and commercialize a Lucendi Semen Performance Analytics (Lucendi SPA) platform. Lucendi SPA will be a rapid (<2 minutes), simple-to-use, inexpensive, compact, lightweight, and portable product for automated analysis of sperm characteristics ideal for repeated and continual testing of male fertility and wellness. Lucendi SPA will be designed based on a novel lens-free microscopy technology developed over the past decade at UCLA by Prof. Ozcan's lab. Lucendi SPA system will consist of a disposable cartridge (for single use) and a multi-use computational reader. Another component of the Lucendi SPA system will be a mobile/web application that tracks and quantifies user's sperm characteristics and quality over time, provides actionable feedback and easy to understand metrics, offers wellness and lifestyle suggestions for improvement of results and stimulates an overall healthy lifestyle, promoting wellness. With the relatively low cost of computational power, we believe that such a compact, light-weight and cost- effective automated semen analysis platform running on a wide-field lensfree on-chip microscope would be especially useful for in-home male fertility tests. Potential other application areas of this unique semen analysis platform are vast and include post-vasectomy tests either at home or in clinics, sperm analysis in fertility clinics (including IVF procedures), semen quality evaluation in sperm banks, stud performance assessment at animal breeding centers, and stud health monitoring in farms. In addition to these, by using a larger-area image sensor, this platform can also be transformed into a significantly higher throughput analysis platform that can measure sperms' response to different drugs or chemicals of various concentrations in parallel.

Public Health Relevance Statement:
Approximately 20% of couples find difficulties conceiving within the first year of trying, and in 40%-50% of these cases male fertility issues may be at the source of the problem. However, partially due to cost and partially due to social stigma associated with clinical evaluation or treatment, male infertility often stays undetected. This proposal aims to develop and commercialize a Semen Performance Analytics (SPA) platform that will be an in-home, rapid (<2 minutes), simple-to-use, inexpensive and field-portable product for automated analysis of sperm characteristics ideal for repeated and continual testing of male fertility and wellness.

Project Terms:
Affect; Algorithmic Analysis; Algorithms; animal breeding; Area; base; Birth; cell motility; Characteristics; Child; Clinic; Clinical; Clinical Treatment; Clinical Trials; Collaborations; Collection; Companions; Computer Assisted; cost; cost effective; Couples; Custom; density; design; Detection; Development; Drug or Chemical; Evaluation; Event; Farming environment; Feedback; Fertility; Gold; graphical user interface; Head; Health; healthy lifestyle; high throughput analysis; Home environment; Human; Image; Image Analysis; imaging platform; improved; Infertility; Internet; intrauterine insemination; Laboratories; Lasers; lens; Life Style; light weight; male; male fertility; Male Infertility; Manuals; Measurement; Measures; meetings; Microscope; Microscopic; Microscopy; mobile application; Modality; Monitor; Motion; novel; Optics; Performance; Phase; portability; Procedures; Process; prototype; Reader; Recommendation; Research; research clinical testing; Resolution; response; Running; Sampling; Secure; Seminal fluid; sensor; social stigma; Societies; Source; Speed; sperm analysis; Sperm Banks; sperm cell; Sperm Count Procedure; Sperm Head; Sperm Motility; sperm quality; statistics; Suction; Suggestion; System; Systems Analysis; Tail; Technology; Testing; Time; TimeLine; Training; Update; Validation; Variant; Vasectomy; web app; Women's Health