# US 5,346,812 A · Teratogen assay

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- Number: US 5,346,812 A
- Document ID: US5346812A
- Status: Granted
- Kind: A
- Application number: 07/946,618
- Filed: 1992-09-18
- Granted: 1994-09-13
- Earliest claimed: 1989-09-07
- Assignees: University of Miami
- Inventors: Richard W. Voellmy; Jayakumar Ananthan-Nair
- Web page: https://patentgrep.com/patent/US5346812A

## CPC

- C12Q 1/6897: involving reporter genes operably linked to promoters
- 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

## Abstract

A method of screening a test substance for potential teratogenicity without employing vertebrate animals. In a representative embodiment, Drosophila primary embryonic cells, containing a hybrid game including a coding sequence for a detectable expression product under the control of a promoter sequence selected from among the 23 and 22 kDa Drosophila heat shock protein promoter sequences, are exposed to the test substance. The cells are thereafter assayed for the detectable expression product, the presence of the expression product in the cells providing an indication of the potential teratogenicity of the test substance. The primary embryonic cells containing the hybrid gene are conveniently provided by transformed flies.

## Claims

### Claim 1

A method of screening a test substance for potential teratogenicity, comprising the steps:
providing primary embryonic cells from a Drosophila transformed via a P element with a hybrid gene comprising a coding sequence for a detectable expression product under the control of the promoter and leader sequence of the 23 kDa Drosophila heat shock protein gene,
exposing said primary embryonic cells in vitro to the test substance, and
assaying in vitro for the detectable expression product in the cells, the presence of the expression product in the cells providing an indication of the potential teratogenicity of the test substance.

### Claim 2 (depends on 1)

The method of claim 1, wherein the detectable expression product is assayed by enzymatic means.

### Claim 3 (depends on 1)

The method of claim 1, wherein the detectable expression product is assayed by immunologic means.