• Title/Summary/Keyword: clinical testing product

Search Result 23, Processing Time 0.021 seconds

Lean Startup Application Study in the Healthcare Industrial point of View : The Case of Humedix Corporation (헬스케어산업 관점에서 본 린스타트업 적용 사례연구: (주)휴메딕스 사례를 중심으로)

  • Lim, Sung-Hoon;Kim, Yong-Tae
    • Asia-Pacific Journal of Business Venturing and Entrepreneurship
    • /
    • v.10 no.3
    • /
    • pp.99-109
    • /
    • 2015
  • The investment in healthcare industry has recently increased not only for global ventures but also for the domestic ventures. However, there has been hardship of founding and investment caused by healthcare startups characteristics that are costly and time consuming. In this study, the applicability of 'Lean Startup' theory to healthcare ventures was explored through the case of a domestic startup which accomplished funding from VC and KOSDAQ after establishing based on its technology in healthcare industry. There have been numerous case studies that applied 'Lean Startup' to IT industry. However, this case study that applied 'Lean Startup' to healthcare industry have some implications as follow: First, it is critical to conduct a hypothesis testing at initial research stage through R&D of 'MVP' (Minimum Viable Product) as the prototype testing is strictly prohibited in healthcare industry. Second, healthcare R&D teams ought to be well organized as startup teams and all researchers should be equipped with entrepreneurship as the licensing process in healthcare industry is time-consuming and costly due to issues like clinical studies. Lastly, management skills as smart and light as 'Lean Startup' are required in order to encourage young engineers' technology startups.

  • PDF

Massive Parallel Sequencing for Diagnostic Genetic Testing of BRCA Genes - a Single Center Experience

  • Ermolenko, Natalya A;Boyarskikh, Uljana A;Kechin, Andrey A;Mazitova, Alexandra M;Khrapov, Evgeny A;Petrova, Valentina D;Lazarev, Alexandr F;Kushlinskii, Nikolay E;Filipenko, Maxim L
    • Asian Pacific Journal of Cancer Prevention
    • /
    • v.16 no.17
    • /
    • pp.7935-7941
    • /
    • 2015
  • The aim of this study was to implement massive parallel sequencing (MPS) technology in clinical genetics testing. We developed and tested an amplicon-based method for resequencing the BRCA1 and BRCA2 genes on an Illumina MiSeq to identify disease-causing mutations in patients with hereditary breast or ovarian cancer (HBOC). The coding regions of BRCA1 and BRCA2 were resequenced in 96 HBOC patient DNA samples obtained from different sample types: peripheral blood leukocytes, whole blood drops dried on paper, and buccal wash epithelia. A total of 16 random DNA samples were characterized using standard Sanger sequencing and applied to optimize the variant calling process and evaluate the accuracy of the MPS-method. The best bioinformatics workflow included the filtration of variants using GATK with the following cut-offs: variant frequency >14%, coverage ($>25{\times}$) and presence in both the forward and reverse reads. The MPS method had 100% sensitivity and 94.4% specificity. Similar accuracy levels were achieved for DNA obtained from the different sample types. The workflow presented herein requires low amounts of DNA samples (170 ng) and is cost-effective due to the elimination of DNA and PCR product normalization steps.

A Test to Compare the Water Resistance Sun Protection Factor of General Water, Artificial Seawater, and Natural Seawater of Sunscreen (자외선 차단제의 일반 물, 인공 해수, 자연 해수의 내수성 차단지수를 비교하기 위한 시험)

  • Hyoung Hoon Hwang;Eun Young Kang;Su Yeong Kim;Hui Jeong Jung;Jun Seong Yang;Won Kyu Hong;Hong Suk Kim
    • Journal of the Society of Cosmetic Scientists of Korea
    • /
    • v.49 no.4
    • /
    • pp.349-354
    • /
    • 2023
  • Sunscreen is a product that protects against ultraviolet rays by blocking and scattering ultraviolet rays, and has now become a daily necessity beyond cosmetics. Applying sunscreen is a common and easy way to prevent skin damage caused by ultraviolet rays. Due to its significance, the evaluation of sunscreen has evolved since its regulation by the FDA in 1978, progressing to standardized methods established by ISO. Additionally, to assess the loss of sunscreen due to activities such as water exposure or sweating, the Ministry of Food and Drug Safety in Korea and ISO have established protocols for evaluating the water-resistant sun protection factor (SPF). However, existing evaluations of water resistance have been mainly confined to test methods involving plain water, and methods accounting for the impact of seawater during activities like beach leisure, sports, and recreation are yet to be established. Based on the existing guidelines for testing the water-resistant UV protection index, this study compared the water-resistant UV protection index in water, artificial seawater (salt water) and natural seawater (sea water) to evaluate the UV protection index in real-world situations such as marine leisure, sports, and leisure activities. Through these results, we were able to compare the differences between water resistance sun protection index tests in ordinary water, artificial seawater, and natural seawater, and suggest a method for water resistance sun protection index tests using natural seawater.

Clinical features of Senior-Loken syndrome with IQCB1/NPHP5 mutation in a Filipino man

  • Chiu, Harold Henrison C.;Sucaldito, Ma. Sergia Fatima P.;Maceda, Ebner Bon G.;Montemayor, Jan Andre S.;Tamondong-Lachica, Diana R.
    • Journal of Genetic Medicine
    • /
    • v.17 no.1
    • /
    • pp.39-42
    • /
    • 2020
  • The Senior-Loken syndrome was first described in 1961 as an oculo-renal disease consisting of familial juvenile nephronophthisis and Leber congenital amaurosis. It is a rare autosomal recessive disorder with a prevalence of 1:1,000,000 caused by mutations in nine genes (NPHP 1-8 and NPHP 10). Ocular manifestations (e.g., photophobia, nystagmus, and extreme hyperopia) occur within the first few years of life while renal manifestations (e.g., formation of multiple cysts impairing kidney function and end-stage renal disease) appear in late childhood to adolescence. Here, we report a case of a Filipino male presenting with rotatory nystagmus and progressive deterioration of vision since childhood. He had congenital amaurosis and juvenile nephronophthisis that progressed to end stage renal disease by age 19. All laboratory and imaging findings were consistent with chronic kidney disease. Molecular genetic testing of ciliopathy-related genes was performed revealing a homozygous mutation in exon 11 of the IQCB1/NPHP5 gene, c.1090C>T (p.Arg364). This sequence change created a premature translational stop signal resulting in a truncated protein product, nephrocystin-5 and its consequent loss of function. His symptoms eventually improved with initiation dialysis. The prognosis of Senior-Loken syndrome remains dismal and a high index of suspicion, early diagnosis and timely intervention of renal complications are warranted.

Convergence Assessment of the Salivary Relationship between dental caries and periodontitis among the University students. - Sill-Ha ST-4910 Salivary Testing Instrument - (일부 여대생의 치아우식병과 치주병 예측을 위한 타액의 융합적 평가 - 타액측정시스템(Sill-Ha ST-4910)이용 -)

  • Choi, Eun-Mi;Kim, Young-Hee
    • Journal of the Korea Convergence Society
    • /
    • v.11 no.7
    • /
    • pp.273-280
    • /
    • 2020
  • Upon investigating the dental health of teeth and gum, and the cleanliness of the oral cavity of female college students in the early 20's, it was reported to be that the number of cariogenic bacteria was heavily related to the acidity of saliva or ammonia. Also, cariogenic bacteria and ammonia was found out to be related with proteins (p<0.01), and ammonia, the synthetic product of cariogenic bacteria was heavily related to blood and white blood cells (p<0.01). To conclude, the healthiness of teeth was related to the acidity of saliva and ammonia, the healthiness of gum was related to blood, proteins and white blood cells while the oral hygiene was most likely to be related to ammonia. This result matched to the seven oral disease cause analyses of the saliva analysis apparatus (Sill-Ha ST-4910), which implied further utilization of this data to clinical implications. However, this study is limited to young personnel who does not have any chronic or general diseases; therefore further study is required to generalize this study.

Comparison of Clinical Outcomes Using Various First-Aid Cooling Method for Burn (다양한 화상 응급처치의 치료효과 비교)

  • Lee, Jung Hwan;Song, Woo Jin;Kwon, Min Ju;Park, Yang Seo;Ko, Jang Hyu
    • Journal of the Korean Burn Society
    • /
    • v.24 no.1
    • /
    • pp.7-13
    • /
    • 2021
  • Purpose: Currently, the most recommended method for burn first aid is the cool running water for 20 minutes (CRW20). If CRW20 is not practicable, cooling dressing products with tea tree oil are used as substitutes. In this study, we analyze the effect of various burn first aids, including CRW20, cooling products, on the treatment period. Methods: This study was conducted on patients who suffered burns and visited Hangangsoo Hospital from March 2019 to March 2020. The study conducted in a retrospective method. The duration of treatment was analyzed by dividing the experimental group. Results: The treatment period was shortened when first aid was given (P<0.001). Cold water, ice, and ice packs resulted in reduced treatment periods (P<0.001, P=0.004). The treatment period was reduced when cooling dressing products were used in all groups (P=0.041). The implementation of first aid has reduced the duration of burn treatment. This means that cooling helps burn treatment. CRW20 did not show statistically meaningful results. This is the result of a failure to fully control the temperature and time of tap water. In addition, the change in temperature of tap water according to season, the use of water is higher than that of animal testing, and the general lack of information on proper burn first aid may have affected. Conclusion: The treatment period was statistically significantly reduced in the group that performed first aid. Among the various first aid methods, cold water and ice reduced the treatment period.

Acute Oral, Pulmonary and Intravenous Toxicity/Pathogenicity Testing of Burkholderia pyrrocinia CAB08106-4 of in Rats (랫드를 이용한 Burkholderia pyrrocinia CAB08106-4의 급성경구, 호흡기, 정맥독성/병원성시험)

  • Kwon, Min;Kang, Tae-Ku;Chung, Chang-Kook;Park, Cheol-Beom
    • The Korean Journal of Pesticide Science
    • /
    • v.17 no.3
    • /
    • pp.193-199
    • /
    • 2013
  • Burkholderia pyrrocinia CAB08106-4 has an anti-bacterial effect on Garlic White Rot caused by Sclereotium cepivorum and Sclereotium sp.. It is an environmentally friendly microbial product that prevents and controls a variety of phytopathogens involving Garlic White Rot caused by Sclereotium cepivorum and Sclereotium sp.. The aim of this study was to assess and to compare the pathogenicity of Burkholderia pyrrocinia CAB08106-4 by single exposure of rats through several routes such as oral, intranasal and intravenous. For the acute toxicity / pathogenicity study, the animals were sacrificed on days 3, 7, 14 and 21, and macroscopically observed their organs to examine the numbers of internally-retained pesticidal microbes. Clinical examinations were performed daily during administration period, and body weight gain was evaluated. In the study, no clinical sign, weight gain and mortality were observed in relation to the administration of test article. The significant changes of internal/external microbes by test article were not detected. The pathological findings in relation to the administration of the test article in the necropsy were not observed. It could be concluded that the microorganism was not toxic or pathogenic in rats via oral, intranasal and intravenous route.

The New in vitro Oral Irritation Test Method for Toothpaste using YD-38 Oral Mucosal Cell Line (치약에 대한 YD-38 세포주를 활용한 새로운 구강 점막 자극 시험방법)

  • Nam, Gi Baeg;Cho, Sun-A;Cho, Jun-Cheol;Kim, Chanho;Kim, Yoo-Jin;Lee, John Hwan;Shin, Kyeho
    • Journal of the Society of Cosmetic Scientists of Korea
    • /
    • v.38 no.4
    • /
    • pp.305-310
    • /
    • 2012
  • Through our entire life, oral care products such as toothpaste are used. Thus the safety of oral care products used every day to our mouth is very important. As the previous study in animal tests or clinical trials, surfactant in toothpaste may cause the oral irritation. However, EU cosmetics legislation prohibits animal testing of cosmetics and its ingredient for animal welfare. Therefore the development of alternative in vitro test has been actively performed to replace or reduce using the animal in many areas. However, the way to evaluate oral mucosal toxicity has been done using animal models or clinical trials from now on. Even more, the experiment with human oral 3D tissue or human oral cell line is used recently. The aim of this study is the development of oral mucosal irritation method without using animal for the safety of the oral care product. We developed in vitro test method for oral irritation by using human oral cell line (YD-38 cell) acceptable to toothpaste which contains insoluble material. By the results of this assay, we could discriminate toothpaste with or without irritating substance as same manner in animal studies reported previously. In addition, we confirmed that toothpaste for babies and children toothpaste irritated oral musoca lower than the general adult toothpaste. The present study suggest that this new in vitro method by using human oral cell line (YD-38 cell) could be used for evaluation of oral irritation without using animal.

Studies on Anti-Wrinkle and Whitening Effects of Liposomes Containing Acerola Extract Mixture (아세로라 추출물 혼합 리포좀의 주름, 미백 효과에 대한 연구)

  • Kim, Su Jin;Oh, Won Jun;Kwon, Sung Pil;Nam, Gaewon
    • Journal of the Society of Cosmetic Scientists of Korea
    • /
    • v.47 no.4
    • /
    • pp.341-352
    • /
    • 2021
  • Acerola is an excellent ingredient because of its high natural vitamin C content, but it is difficult to stabilize and has hardly been studied as a cosmetic material. Therefore, this study developed a mixed liposome preparation for stabilizing acerola extract. As a safety test, the skin irritation test was evaluated by BCOP assay and HET-CAM assay. We evaluated the inhibition of tyrosinase activity, the whitening effect of melanin production, and the wrinkle effect of prochloragentype-I C-peptide production, and confirmed the possibility of functional cosmetics. In addition, a cream of liposomes containing acerola extract mixture was developed to evaluate the clinical studies of skin wrinkles and whitening. BCOP assay, HET-CAM assay and human skin primary irritation test results of liposomes containing acerola extract mixture showed no irritation and were safe from skin and eye. The result of tyrosinase activity by 75.8% at 1,000 ㎍/mL. As a result of the melanogenesis inhibition test, liposome with acerola extract showed the melanin content by 46.2% at 1,000 ㎍/mL that does not effect the viability of the B16F10 cell line. The result of collagen production test using ELISA kit, liposomes containing acerola extract mixture showed collagen synthesis ability by 152.1% at 1,000 ㎍/mL that does not affect the viability of the HS68 cell line. But it did not showed any inhibition of collagenase (MMP-1) activity at all concentrations in the MMP-1 activity inhibition test in the HS68 cell line. We performed clinical studies for the whitening and skin-wrinkle activity of cream containing acerola extract mixes liposome, was showed that the melanin contents and wrinkle was statistically significant reduction. These results suggest that liposomes containing acerola extract mixture have safe natural material, and skin wrinkle, whitening effects allowing their application in cosmetics as a natural product.

VCUG Studies on the Clinical Usefulness of Aids (VCUG 보조기구의 임상적 유용성에 관한 고찰)

  • Choe, Dea yeon;Kim, Dong hyun
    • Journal of the Korean Society of Radiology
    • /
    • v.9 no.7
    • /
    • pp.529-533
    • /
    • 2015
  • VCUG(Voiding Cystourethrography) study is being performed to check urinary reflex symptom from bladder to ureter or kidney in the method of filling the bladder with radiation opaque contrast agent. However, VCUG study have been performed impersonally, patients have to be naked and open their legs and then void. This method is so impersonal that it is immediately needed to improve the way of testing and crete new aid. Therefore, this study through producing underwear for VCUG, analysis and compares the test time of VCUG, patient radiation dose and patient satisfaction. The target of this study was 79 Male and Female patients who visited genitourinary clinic of PNUYH for their VCUG tests AXIUM Iconos R200(Siemens Medical System : Germany) and self-produced plastic underwears made by vinyl and plasic molding machine were used. The 79 patient were divided into two groups : experiment of patient and comparison group of we patient (using aid) in order to compare, testing time, DAP (dose area product) and patient satisfaction. There was time reduction, from 35.3min of comparison group to 27.8min experimentation group by 7.5min decrease. And comparison group of $4566.6{\mu}Gym^2$(DAP) decreased experimental group (using aid) of $3411.9{\mu}Gym^2$ by $1154.7{\mu}Gym^2$. In the case of patients satisfaction study, anxiety had a drop by 3.45 of comparison group to 2.51 experimentation group by 0.94 decrease. in experimental group. And shame had a drop by 4.02 of comparison group to 3.08 experimentation group by 0.94 increase. in experimental group. Difference of the smooth voiding had a drop by 1.90 of comparison group to 2.84 experimentation group by 0.94 increase. in experimental group. In addition satisfaction had a rise by 1.19 in experimental group. There were also other opinions of uncomfortableness on it and troublesome to wear. VCUG is one of the sensitive care required test. Therefore staff and the aid can give patients such comfortable and the aid can consentive on voiding. As a result test time and DAP can be reduced. It is needed to make testing at more comfortable for patients.