# US 5,344,762 A · Method for the early diagnosis of cancer

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- Number: US 5,344,762 A
- Document ID: US5344762A
- Status: Granted
- Kind: A
- Application number: 08/038,674
- Filed: 1993-03-26
- Granted: 1994-09-06
- Earliest claimed: 1992-03-29
- Assignees: ERA-Masis, Ltd.
- Inventors: Anait Karapetian
- Web page: https://patentgrep.com/patent/US5344762A

## CPC

- C12Q 1/14: Streptococcus; Staphylococcus
- C12Q 1/10: Enterobacteria
- G01N 33/56916: {Enterobacteria, e.g. shigella, salmonella, klebsiella, serratia}
- G01N 33/56944: {Streptococcus}
- G01N 33/575: for cancer
- G01N 2333/245: Escherichia (G)
- G01N 2333/315: from Streptococcus (G), e.g. Enterococci
- Y10S 435/848: Escherichia
- Y10S 435/885: Streptococcus
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

In a method for early diagnosis of human cancer, a human fecal sample of bacteria (Escherichia coli and/or Streptococcus faecalis), is incubated in vitro with a standard culture of a known number of cancer cells, for a period of time sufficient to enable the extent of interaction between the bacteria and the standard culture of cancer cells to be determined; the number of the interacted and/or non-interacted cancer cells present at the end of the period is determined and is utilized for the diagnosis based on the calculation of a tumor cell necrosis index (TCNI). The extent of interaction referred to may be calibrated against analogous interaction using a control preparation of bacteria, e.g. Escherichia coli A.T.C.C. 55373, 55374 and/or 55375, and/or Streptococcus faecalis A.T.C.C. 55376.

## Claims

### Claim 1

A method for the early diagnosis of cancer in a human, wherein a human feces-derived sample of bacteria selected from the group consisting of Escherichia coli and Streptococcus faecalis, is subjected to incubation in vitro with a standard culture of cancer cells containing a predetermined number of cancer cells, for a period of time sufficient to enable the extent of interaction between said bacteria and said standard culture of cancer cells to be determined, the number of the interacted and/or non-interacted cancer cells present at the end of the period of time being determined and being utilized for the purpose of said diagnosis based on the calculation of a tumor cell necrosis index (TCNI).

### Claim 2 (depends on 1)

A method according to claim 1, wherein said period of time lies within the range of about 2 to about 6 hours.

### Claim 3 (depends on 1)

A method according to claim 1, wherein said determination is made by counting the number of cancer cells remaining in the visual field of a microscope of a smear on a microscope slide, after fixing and dyeing.

### Claim 4 (depends on 2)

A method according to claim 2, wherein said determination is made by counting the number of cancer cells remaining in the visual field of a microscope of a smear on a microscope slide, after fixing and dyeing.

### Claim 5

A method for the early diagnosis of cancer in a human, wherein a human feces-derived sample of bacteria selected from the group consisting of Escherichia coli and Streptococcus faecalis, is subjected to incubation in vitro with a standard culture of cancer cells containing a predetermined number of cancer cells, for a period of time sufficient to enable the extent of interaction between said bacteria and said standard culture of cancer cells to be determined, the number of the interacted and/or non-interacted cancer cells present at the end of the period of time being determined and being utilized for the purpose of said diagnosis based on the calculation of a tumor cell necrosis index (TCNI), and wherein said extent of interaction between said bacteria and said standard culture of cancer cells is calibrated against the extent of interaction between a control preparation of bacteria incubated under the same conditions and said standard culture of cancer cells.

### Claim 6 (depends on 5)

A method according to claim 5, wherein said period of time lies within the range of about 2 to about 6 hours.

### Claim 7 (depends on 5)

A method according to claim 5, wherein said determination is made by counting the number of cancer cells remaining in the visual field of a microscope of a smear on a microscope slide, after fixing and dyeing.

### Claim 8 (depends on 6)

A method according to claim 6, wherein said determination is made by counting the number of cancer cells remaining in the visual field of a microscope of a smear on a microscope slide, after fixing and dyeing.

### Claim 9

A method for the early diagnosis of cancer in a human, wherein a human feces-derived sample of bacteria selected from the group consisting of Escherichia coli and Streiptococcus faecalis, is subjected to incubation in vitro with a standard culture of cancer cells containing a predetermined number of cancer cells, for a period of time sufficient to enable the extent of interaction between said bacteria and said standard culture of cancer cells to be determined, the number of the interacted and/or non-interacted cancer cells present at the end of the period of time being determined and being utilized for the purpose of said diagnosis based on the calculation of a tumor cell necrosis index (TCNI), wherein said extent of interaction between said bacteria and said standard culture of cancer cells is calibrated against the extent of interaction between a control preparation of bacteria incubated under the same conditions and said standard culture of cancer cells, and wherein in said control preparation of bacteria, there is used at least one strain selected from the group consisting of Escherichi coli A.T.C.C. 55373, Escherichia coli A.T.C.C. 55374, Escherichia coli A.T.C.C. 55375 and Streptococcus faecalis A.T.C.C. 55376.

### Claim 10 (depends on 9)

A method according to claim 9, wherein said period of time lies within the range of about 2 to about 6 hours.

### Claim 11 (depends on 9)

A method according to claim 9, wherein said determination is made by counting the number of cancer cells remaining in the visual field of a microscope of a smear on a microscope slide, after fixing and dyeing.

### Claim 12 (depends on 10)

A method according to claim 10, wherein said determination is made by counting the number of cancer cells remaining in the visual field of a microscope of a smear on a microscope slide, after fixing and dyeing.
